Part 201View 21 CFR 201.128Meaning of “intended uses”Letters3212026 so far81 +23 vs 2025Part 211View 21 CFR 211.22Responsibilities of quality control unitLetters2922026 so far66 +14 vs 2025Part 211View 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closuresLetters2752026 so far46 -3 vs 2025Part 211View 21 CFR 211.100Written procedures; deviationsLetters2432026 so far43 -1 vs 2025Part 201View 21 CFR 201.5Drugs; adequate directions for useLetters2092026 so far30 +5 vs 2025Part 211View 21 CFR 211.165Testing and release for distributionLetters2022026 so far28 -4 vs 2025Part 211View 21 CFR 211.192Production record reviewLetters1932026 so far41 +5 vs 2025Part 211View 21 CFR 211.166Stability testingLetters1662026 so far28 -5 vs 2025Part 211View 21 CFR 211.160General requirementsLetters1402026 so far38 +18 vs 2025Part 201View 21 CFR 201.115New drugs or new animal drugsLetters1342026 so far26 -6 vs 2025Part 211View 21 CFR 211.113Control of microbiological contaminationLetters1152026 so far32 +11 vs 2025Part 820View 21 CFR 820.30Design controlsLetters1122026 so far16 -11 vs 2025Part 211View 21 CFR 211.67Equipment cleaning and maintenanceLetters1062026 so far17 same vs 2025Part 820View 21 CFR 820.100Corrective and preventive actionLetters1052026 so far16 -10 vs 2025Part 807View 21 CFR 807.81When a premarket notification submission is requiredLetters1002026 so far19 -1 vs 2025Part 211View 21 CFR 211.42Design and construction featuresLetters982026 so far27 +7 vs 2025Part 820View 21 CFR 820.198Complaint filesLetters912026 so far12 -14 vs 2025Part 211View 21 CFR 211.188Batch production and control recordsLetters762026 so far14 +2 vs 2025Part 803View 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?Letters632026 so far7 -12 vs 2025Part 803View 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?Letters562026 so far7 -6 vs 2025Part 330View 21 CFR 330.1General conditions for general recognition as safe, effective and not misbrandedLetters552026 so far0 -1 vs 2025Part 201View 21 CFR 201.1Drugs; name and place of business of manufacturer, packer, or distributorLetters522026 so far51 +51 vs 2025Part 1271View 21 CFR 1271.3How does FDA define important terms in this part?Letters522026 so far8 -1 vs 2025Part 803View 21 CFR 803.3How does FDA define the terms used in this part?Letters512026 so far7 -6 vs 2025Part 820View 21 CFR 820.75Process validationLetters512026 so far5 -7 vs 2025Part 820View 21 CFR 820.50Purchasing controlsLetters492026 so far7 -8 vs 2025Part 201View 21 CFR 201.66Format and content requirements for over-the-counter (OTC) drug product labelingLetters462026 so far3 -3 vs 2025Part 211View 21 CFR 211.194Laboratory recordsLetters462026 so far15 +8 vs 2025Part 312View 21 CFR 312.60General responsibilities of investigatorsLetters442026 so far10 +2 vs 2025Part 211View 21 CFR 211.68Automatic, mechanical, and electronic equipmentLetters432026 so far5 -5 vs 2025Part 820View 21 CFR 820.90Nonconforming productLetters432026 so far5 -8 vs 2025Part 200View 21 CFR 200.10Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical manufacturersLetters412026 so far8 -2 vs 2025Part 210View 21 CFR 210.1Status of current good manufacturing practice regulationsLetters412026 so far8 -2 vs 2025Part 820View 21 CFR 820.80Receiving, in-process, and finished device acceptanceLetters402026 so far4 -6 vs 2025Part 211View 21 CFR 211.180General requirementsLetters392026 so far6 -3 vs 2025Part 1271View 21 CFR 1271.10Are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part, and if so what must I do?Letters362026 so far6 same vs 2025Part 1271View 21 CFR 1271.15Are there any exceptions from the requirements of this part?Letters362026 so far6 same vs 2025Part 820View 21 CFR 820.70Production and process controlsLetters312026 so far4 -3 vs 2025Part 806View 21 CFR 806.10Reports of corrections and removalsLetters302026 so far7 -3 vs 2025Part 211View 21 CFR 211.137Expiration datingLetters282026 so far4 -2 vs 2025Part 207View 21 CFR 207.57What information must registrants submit when updating listing information and when?Letters272026 so far2 -3 vs 2025Part 820View 21 CFR 820.22Quality auditLetters262026 so far4 -4 vs 2025Part 820View 21 CFR 820.184Device history recordLetters262026 so far2 -5 vs 2025Part 211View 21 CFR 211.63Equipment design, size, and locationLetters252026 so far6 +1 vs 2025Part 211View 21 CFR 211.198Complaint filesLetters242026 so far4 +1 vs 2025Part 801View 21 CFR 801.20Label to bear a unique device identifierLetters242026 so far5 -3 vs 2025Part 830View 21 CFR 830.300Devices subject to device identification data submission requirementsLetters242026 so far5 -2 vs 2025Part 211View 21 CFR 211.25Personnel qualificationsLetters232026 so far6 same vs 2025Part 312View 21 CFR 312.2ApplicabilityLetters232026 so far2 -1 vs 2025Part 830View 21 CFR 830.3DefinitionsLetters222026 so far5 -1 vs 2025Part 201View 21 CFR 201.100Prescription drugs for human useLetters212026 so far0 -1 vs 2025Part 803View 21 CFR 803.18What are the requirements for establishing and maintaining MDR files or records that apply to me?Letters212026 so far2 -4 vs 2025Part 207View 21 CFR 207.41Who must list drugs and what drugs must they list?Letters202026 so far5 +4 vs 2025Part 207View 21 CFR 207.77What legal status is conferred by registration and listing?Letters192026 so far3 -1 vs 2025Part 803View 21 CFR 803.12How do I submit initial and supplemental or followup reports?Letters192026 so far3 -4 vs 2025Part 820View 21 CFR 820.20Management responsibilityLetters192026 so far3 -3 vs 2025Part 207View 21 CFR 207.49What listing information must a registrant submit for a drug it manufactures?Letters182026 so far3 same vs 2025Part 312View 21 CFR 312.20Requirement for an INDLetters182026 so far2 -1 vs 2025Part 801View 21 CFR 801.3DefinitionsLetters182026 so far3 -2 vs 2025Part 820View 21 CFR 820.25PersonnelLetters182026 so far2 -6 vs 2025Part 1271View 21 CFR 1271.75How do I screen a donor?Letters182026 so far4 +2 vs 2025Part 1271View 21 CFR 1271.20If my HCT/P's do not meet the criteria in § 1271.10, and I do not qualify for any of the exceptions in § 1271.15, what regulations apply?Letters172026 so far6 same vs 2025Part 111View 21 CFR 111.70What specifications must you establish?Letters162026 so far2 same vs 2025Part 801View 21 CFR 801.40Form of a unique device identifierLetters162026 so far3 -2 vs 2025Part 101View 21 CFR 101.9Nutrition labeling of foodLetters152026 so far0 -1 vs 2025Part 314View 21 CFR 314.81Other postmarketing reportsLetters152026 so far2 -7 vs 2025Part 111View 21 CFR 111.260What must the batch record include?Letters142026 so far3 +1 vs 2025Part 207View 21 CFR 207.17Who must register?Letters142026 so far2 +2 vs 2025Part 803View 21 CFR 803.20How do I complete and submit an individual adverse event report?Letters142026 so far3 same vs 2025Part 50View 21 CFR 50.20General requirements for informed consentLetters132026 so far6 +3 vs 2025Part 101View 21 CFR 101.4Food; designation of ingredientsLetters132026 so far0 -1 vs 2025Part 101View 21 CFR 101.36Nutrition labeling of dietary supplementsLetters132026 so far0 -1 vs 2025Part 111View 21 CFR 111.75What must you do to determine whether specifications are met?Letters132026 so far2 +1 vs 2025Part 202View 21 CFR 202.1Prescription-drug advertisementsLetters132026 so far2 -6 vs 2025Part 211View 21 CFR 211.58MaintenanceLetters132026 so far4 +2 vs 2025Part 310View 21 CFR 310.305Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applicationsLetters132026 so far1 -3 vs 2025Part 807View 21 CFR 807.39Misbranding by reference to establishment registration or to registration numberLetters132026 so far1 +1 vs 2025Part 1271View 21 CFR 1271.60What quarantine and other requirements apply before the donor-eligibility determination is complete?Letters132026 so far3 +1 vs 2025Part 111View 21 CFR 111.255What is the requirement to establish a batch production record?Letters122026 so far2 same vs 2025Part 820View 21 CFR 820.40Document controlsLetters122026 so far1 -2 vs 2025Part 820View 21 CFR 820.181Device master recordLetters122026 so far0 -2 vs 2025Part 1271View 21 CFR 1271.85What donor testing is required for different types of cells and tissues?Letters122026 so far3 +1 vs 2025Part 1271View 21 CFR 1271.90Are there other exceptions and what labeling requirements apply?Letters122026 so far3 +1 vs 2025Part 1271View 21 CFR 1271.155Exemptions and alternativesLetters122026 so far3 +1 vs 2025Part 58View 21 CFR 58.35Quality assurance unitLetters112026 so far2 same vs 2025Part 211View 21 CFR 211.110Sampling and testing of in-process materials and drug productsLetters112026 so far2 -1 vs 2025Part 1271View 21 CFR 1271.47What procedures must I establish and maintain?Letters112026 so far2 same vs 2025Part 1271View 21 CFR 1271.80What are the general requirements for donor testing?Letters112026 so far2 same vs 2025Part 101View 21 CFR 101.3Identity labeling of food in packaged formLetters102026 so far0 same vs 2025Part 211View 21 CFR 211.56SanitationLetters102026 so far0 -1 vs 2025Part 312View 21 CFR 312.40General requirements for use of an investigational new drug in a clinical investigationLetters102026 so far2 -1 vs 2025Part 312View 21 CFR 312.62Investigator recordkeeping and record retentionLetters102026 so far2 +1 vs 2025Part 820View 21 CFR 820.72Inspection, measuring, and test equipmentLetters102026 so far0 -2 vs 2025Part 890View 21 CFR 890.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)Letters102026 so far1 -3 vs 2025Part 58View 21 CFR 58.33Study directorLetters92026 so far1 -1 vs 2025Part 111View 21 CFR 111.210What must the master manufacturing record include?Letters92026 so far2 +2 vs 2025Part 170View 21 CFR 170.30Eligibility for classification as generally recognized as safe (GRAS)Letters92026 so far0 -3 vs 2025Part 207View 21 CFR 207.29What are the requirements for reviewing and updating registration information?Letters92026 so far2 +2 vs 2025Part 211View 21 CFR 211.167Special testing requirementsLetters92026 so far1 -3 vs 2025Part 1271View 21 CFR 1271.45What requirements does this subpart contain?Letters92026 so far2 same vs 2025Part 1271View 21 CFR 1271.50How do I determine whether a donor is eligible?Letters92026 so far2 +1 vs 2025Part 50View 21 CFR 50.23Exception from general requirementsLetters82026 so far2 -1 vs 2025Part 101View 21 CFR 101.12Reference amounts customarily consumed per eating occasionLetters82026 so far0 same vs 2025Part 101View 21 CFR 101.93Certain types of statements for dietary supplementsLetters82026 so far1 +1 vs 2025Part 111View 21 CFR 111.95Under this subpart E, what records must you make and keep?Letters82026 so far0 same vs 2025Part 111View 21 CFR 111.103What are the requirements under this subpart F for written procedures?Letters82026 so far0 -2 vs 2025Part 200View 21 CFR 200.50Ophthalmic preparations and dispensersLetters82026 so far0 same vs 2025Part 201View 21 CFR 201.10Drugs; statement of ingredientsLetters82026 so far2 same vs 2025Part 207View 21 CFR 207.33What is the National Drug Code (NDC), how is it assigned, and what are its requirements?Letters82026 so far1 -1 vs 2025Part 211View 21 CFR 211.34ConsultantsLetters82026 so far1 +1 vs 2025Part 211View 21 CFR 211.130Packaging and labeling operationsLetters82026 so far2 +1 vs 2025Part 310View 21 CFR 310.545Drug products containing certain active ingredients offered over-the-counter (OTC) for certain usesLetters82026 so far1 +1 vs 2025Part 312View 21 CFR 312.66Assurance of IRB reviewLetters82026 so far0 -1 vs 2025Part 820View 21 CFR 820.3DefinitionsLetters82026 so far1 -2 vs 2025Part 820View 21 CFR 820.120Device labelingLetters82026 so far0 -4 vs 2025Part 50View 21 CFR 50.24Exception from informed consent requirements for emergency researchLetters72026 so far2 -1 vs 2025Part 101View 21 CFR 101.5Food; name and place of business of manufacturer, packer, or distributorLetters72026 so far0 same vs 2025Part 111View 21 CFR 111.205What is the requirement to establish a master manufacturing record?Letters72026 so far2 +1 vs 2025Part 210View 21 CFR 210.3DefinitionsLetters72026 so far1 same vs 2025Part 820View 21 CFR 820.86Acceptance statusLetters72026 so far0 -3 vs 2025Part 1271View 21 CFR 1271.2Letters72026 so far2 +1 vs 2025Part 1271View 21 CFR 1271.55What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?Letters72026 so far1 same vs 2025Part 56View 21 CFR 56.109IRB review of researchLetters62026 so far0 -1 vs 2025Part 58View 21 CFR 58.81Standard operating proceduresLetters62026 so far1 same vs 2025Part 111View 21 CFR 111.73What is your responsibility for determining whether established specifications are met?Letters62026 so far1 same vs 2025Part 201View 21 CFR 201.61Statement of identityLetters62026 so far0 same vs 2025Part 211View 21 CFR 211.170Reserve samplesLetters62026 so far1 same vs 2025Part 312View 21 CFR 312.7Promotion of investigational drugsLetters62026 so far0 same vs 2025Part 803View 21 CFR 803.52If I am a manufacturer, what information must I submit in my individual adverse event reports?Letters62026 so far3 same vs 2025Part 820View 21 CFR 820.160DistributionLetters62026 so far0 -2 vs 2025Part 820View 21 CFR 820.250Statistical techniquesLetters62026 so far1 -2 vs 2025Part 890View 21 CFR 890.5500Infrared lampLetters62026 so far0 -3 vs 2025Part 1271View 21 CFR 1271.1What are the purpose and scope of this part?Letters62026 so far3 +1 vs 2025Part 1271View 21 CFR 1271.65How do I store an HCT/P from a donor determined to be ineligible, and what uses of the HCT/P are not prohibited?Letters62026 so far2 +1 vs 2025Part 50View 21 CFR 50.27Documentation of informed consentLetters52026 so far1 same vs 2025Part 56View 21 CFR 56.115IRB recordsLetters52026 so far0 same vs 2025Part 58View 21 CFR 58.185Reporting of nonclinical laboratory study resultsLetters52026 so far1 same vs 2025Part 58View 21 CFR 58.202Grounds for disqualificationLetters52026 so far0 -2 vs 2025Part 101View 21 CFR 101.2Information panel of package form foodLetters52026 so far0 same vs 2025Part 101View 21 CFR 101.7Declaration of net quantity of contentsLetters52026 so far0 same vs 2025Part 101View 21 CFR 101.15Food; prominence of required statementsLetters52026 so far0 same vs 2025Part 211View 21 CFR 211.28Personnel responsibilitiesLetters52026 so far0 -1 vs 2025Part 312View 21 CFR 312.3Definitions and interpretationsLetters52026 so far1 +1 vs 2025Part 314View 21 CFR 314.3DefinitionsLetters52026 so far0 same vs 2025ISO 13485View ISO 13485 7.1Planning of product realizationLetters52026 so far5 +5 vs 2025Part 50View 21 CFR 50.25Elements of informed consentLetters42026 so far2 +2 vs 2025Part 56View 21 CFR 56.108IRB functions and operationsLetters42026 so far0 same vs 2025Part 58View 21 CFR 58.31Testing facility managementLetters42026 so far1 +1 vs 2025Part 58View 21 CFR 58.90Animal careLetters42026 so far0 -2 vs 2025Part 111View 21 CFR 111.25What are the requirements under this subpart D for written procedures?Letters42026 so far0 same vs 2025Part 111View 21 CFR 111.105What must quality control personnel do?Letters42026 so far1 +1 vs 2025Part 111View 21 CFR 111.113What quality control operations are required for a material review and disposition decision?Letters42026 so far1 +1 vs 2025Part 111View 21 CFR 111.453What are the requirements under this subpart for M written procedures?Letters42026 so far0 same vs 2025Part 111View 21 CFR 111.503What are the requirements under this subpart N for written procedures?Letters42026 so far0 same vs 2025Part 111View 21 CFR 111.553What are the requirements under this subpart O for written procedures?Letters42026 so far0 same vs 2025Part 201View 21 CFR 201.15Drugs; prominence of required label statementsLetters42026 so far0 same vs 2025Part 211View 21 CFR 211.94Drug product containers and closuresLetters42026 so far0 same vs 2025Part 211View 21 CFR 211.125Labeling issuanceLetters42026 so far1 same vs 2025Part 211View 21 CFR 211.142Warehousing proceduresLetters42026 so far2 +2 vs 2025Part 211View 21 CFR 211.182Equipment cleaning and use logLetters42026 so far0 -1 vs 2025Part 211View 21 CFR 211.186Master production and control recordsLetters42026 so far0 -1 vs 2025Part 320View 21 CFR 320.31Applicability of requirements regarding an “Investigational New Drug Application.”Letters42026 so far3 +3 vs 2025Part 803View 21 CFR 803.56If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?Letters42026 so far1 -1 vs 2025Part 820View 21 CFR 820.200ServicingLetters42026 so far0 -3 vs 2025ISO 13485View ISO 13485 7.4.1Purchasing processLetters42026 so far4 +4 vs 2025ISO 13485View ISO 13485 8.5.2Corrective actionLetters42026 so far4 +4 vs 2025Part 1View 21 CFR 1.74Human drugsLetters32026 so far1 same vs 2025Part 3View 21 CFR 3.2DefinitionsLetters32026 so far0 same vs 2025Part 50View 21 CFR 50.22Exception from informed consent requirements for minimal risk clinical investigationsLetters32026 so far3 +3 vs 2025Part 58View 21 CFR 58.130Conduct of a nonclinical laboratory studyLetters32026 so far0 -1 vs 2025Part 81View 21 CFR 81.30Cancellation of certificatesLetters32026 so far3 +3 vs 2025Part 101View 21 CFR 101.54Nutrient content claims for “good source,” “high,” “more,” and “high potency.”Letters32026 so far0 same vs 2025Part 111View 21 CFR 111.27What requirements apply to the equipment and utensils that you use?Letters32026 so far0 same vs 2025Part 111View 21 CFR 111.35Under this subpart D, what records must you make and keep?Letters32026 so far0 same vs 2025Part 111View 21 CFR 111.65What are the requirements for quality control operations?Letters32026 so far0 -1 vs 2025Part 111View 21 CFR 111.315What are the requirements for laboratory control processes?Letters32026 so far1 +1 vs 2025Part 111View 21 CFR 111.475Under this subpart M, what records must you make and keep?Letters32026 so far0 same vs 2025Part 111View 21 CFR 111.535Under this subpart N, what records must you make and keep?Letters32026 so far0 same vs 2025Part 190View 21 CFR 190.6Requirement for premarket notificationLetters32026 so far0 same vs 2025Part 207View 21 CFR 207.30Letters32026 so far1 +1 vs 2025Part 211View 21 CFR 211.80General requirementsLetters32026 so far1 +1 vs 2025Part 211View 21 CFR 211.101Charge-in of componentsLetters32026 so far0 same vs 2025Part 212View 21 CFR 212.30What requirements must my facilities and equipment meet?Letters32026 so far1 +1 vs 2025Part 310View 21 CFR 310.548Drug products containing colloidal silver ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of diseaseLetters32026 so far0 -2 vs 2025Part 312View 21 CFR 312.57Recordkeeping and record retentionLetters32026 so far0 -1 vs 2025Part 600View 21 CFR 600.3DefinitionsLetters32026 so far0 same vs 2025Part 806View 21 CFR 806.2DefinitionsLetters32026 so far0 same vs 2025Part 807View 21 CFR 807.20Who must register and submit a device list?Letters32026 so far0 same vs 2025Part 812View 21 CFR 812.40General responsibilities of sponsorsLetters32026 so far1 same vs 2025Part 820View 21 CFR 820.60IdentificationLetters32026 so far0 -2 vs 2025Part 820View 21 CFR 820.180General requirementsLetters32026 so far0 -2 vs 2025Part 820View 21 CFR 820.186Quality system recordLetters32026 so far0 -1 vs 2025Part 882View 21 CFR 882.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)Letters32026 so far0 same vs 2025Part 1271View 21 CFR 1271.230Process validationLetters32026 so far0 same vs 2025ISO 13485View ISO 13485 7.3.1GeneralLetters32026 so far3 +3 vs 2025ISO 13485View ISO 13485 7.3.9Control of design and development changesLetters32026 so far3 +3 vs 2025ISO 13485View ISO 13485 7.6Control of monitoring and measuring equipmentLetters32026 so far3 +3 vs 2025Part 50View 21 CFR 50.55Requirements for permission by parents or guardians and for assent by childrenLetters22026 so far0 -1 vs 2025Part 56View 21 CFR 56.113Suspension or termination of IRB approval of researchLetters22026 so far0 same vs 2025Part 58View 21 CFR 58.29PersonnelLetters22026 so far0 same vs 2025Part 58View 21 CFR 58.190Storage and retrieval of records and dataLetters22026 so far0 -1 vs 2025Part 111View 21 CFR 111.15What sanitation requirements apply to your physical plant and grounds?Letters22026 so far1 +1 vs 2025Part 111View 21 CFR 111.55What are the requirements to implement a production and process control system?Letters22026 so far0 same vs 2025Part 111View 21 CFR 111.83What are the requirements for reserve samples?Letters22026 so far0 -1 vs 2025Part 111View 21 CFR 111.123What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing operations?Letters22026 so far0 same vs 2025Part 111View 21 CFR 111.127What quality control operations are required for packaging and labeling operations?Letters22026 so far0 same vs 2025Part 111View 21 CFR 111.140Under this subpart F, what records must you make and keep?Letters22026 so far0 same vs 2025Part 111View 21 CFR 111.320What requirements apply to laboratory methods for testing and examination?Letters22026 so far0 same vs 2025Part 111View 21 CFR 111.560What requirements apply to the review and investigation of a product complaint?Letters22026 so far0 same vs 2025Part 117View 21 CFR 117.35Sanitary operationsLetters22026 so far1 +1 vs 2025Part 117View 21 CFR 117.135Preventive controlsLetters22026 so far1 +1 vs 2025Part 207View 21 CFR 207.1What definitions and interpretations of terms apply to this part?Letters22026 so far1 +1 vs 2025Part 211View 21 CFR 211.87Retesting of approved components, drug product containers, and closuresLetters22026 so far0 -1 vs 2025Part 211View 21 CFR 211.150Distribution proceduresLetters22026 so far1 +1 vs 2025Part 212View 21 CFR 212.20What activities must I perform to ensure drug quality?Letters22026 so far1 +1 vs 2025Part 312View 21 CFR 312.21Phases of an investigationLetters22026 so far0 -1 vs 2025Part 312View 21 CFR 312.50General responsibilities of sponsorsLetters22026 so far0 -1 vs 2025Part 330View 21 CFR 330.2Pregnancy-nursing warningLetters22026 so far0 same vs 2025Part 610View 21 CFR 610.12SterilityLetters22026 so far0 same vs 2025Part 801View 21 CFR 801.4Meaning of intended usesLetters22026 so far1 same vs 2025Part 801View 21 CFR 801.6Medical devices; misleading statementsLetters22026 so far0 same vs 2025Part 803View 21 CFR 803.10Generally, what are the reporting requirements that apply to me?Letters22026 so far0 -2 vs 2025Part 807View 21 CFR 807.3DefinitionsLetters22026 so far0 same vs 2025Part 809View 21 CFR 809.10Labeling for in vitro diagnostic productsLetters22026 so far0 same vs 2025Part 812View 21 CFR 812.46Monitoring investigationsLetters22026 so far1 same vs 2025Part 812View 21 CFR 812.100General responsibilities of investigatorsLetters22026 so far1 same vs 2025Part 812View 21 CFR 812.140RecordsLetters22026 so far1 same vs 2025Part 820View 21 CFR 820.5Quality systemLetters22026 so far1 same vs 2025Part 820View 21 CFR 820.140HandlingLetters22026 so far0 -1 vs 2025Part 820View 21 CFR 820.150StorageLetters22026 so far0 -1 vs 2025Part 862View 21 CFR 862.1355Integrated continuous glucose monitoring systemLetters22026 so far1 same vs 2025Part 878View 21 CFR 878.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)Letters22026 so far1 +1 vs 2025Part 878View 21 CFR 878.4040Surgical apparelLetters22026 so far0 same vs 2025Part 882View 21 CFR 882.1275Electroconductive mediaLetters22026 so far1 +1 vs 2025Part 882View 21 CFR 882.5890Transcutaneous electrical nerve stimulator for pain reliefLetters22026 so far1 +1 vs 2025Part 886View 21 CFR 886.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)Letters22026 so far1 same vs 2025Part 890View 21 CFR 890.5360Measuring exercise equipmentLetters22026 so far0 -2 vs 2025Part 1010View 21 CFR 1010.2CertificationLetters22026 so far1 same vs 2025Part 1020View 21 CFR 1020.30Diagnostic x-ray systems and their major componentsLetters22026 so far0 -1 vs 2025Part 1271View 21 CFR 1271.195Environmental control and monitoringLetters22026 so far0 same vs 2025Part 1271View 21 CFR 1271.220Processing and process controlsLetters22026 so far0 same vs 2025Part 1271View 21 CFR 1271.265Receipt, predistribution shipment, and distribution of an HCT/PLetters22026 so far0 same vs 2025Part 1271View 21 CFR 1271.350ReportingLetters22026 so far0 same vs 2025Part 1View 21 CFR 1.226Who does not have to register under this subpart?Letters12026 so far0 same vs 2025Part 7View 21 CFR 7.3DefinitionsLetters12026 so far1 +1 vs 2025Part 11View 21 CFR 11.260Letters12026 so far0 same vs 2025Part 50View 21 CFR 50.3DefinitionsLetters12026 so far1 +1 vs 2025Part 50View 21 CFR 50.33Letters12026 so far1 +1 vs 2025Part 50View 21 CFR 50.52Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjectsLetters12026 so far0 -1 vs 2025Part 56View 21 CFR 56.104Exemptions from IRB requirementLetters12026 so far0 same vs 2025Part 56View 21 CFR 56.107IRB membershipLetters12026 so far0 same vs 2025Part 58View 21 CFR 58.43Animal care facilitiesLetters12026 so far0 -1 vs 2025Part 58View 21 CFR 58.49Laboratory operation areasLetters12026 so far0 -1 vs 2025Part 58View 21 CFR 58.51Specimen and data storage facilitiesLetters12026 so far0 -1 vs 2025Part 58View 21 CFR 58.61Equipment designLetters12026 so far1 +1 vs 2025Part 58View 21 CFR 58.107Test and control article handlingLetters12026 so far0 -1 vs 2025Part 58View 21 CFR 58.113Mixtures of articles with carriersLetters12026 so far1 +1 vs 2025Part 58View 21 CFR 58.120ProtocolLetters12026 so far0 same vs 2025Part 101View 21 CFR 101.13Nutrient content claims, general principlesLetters12026 so far0 same vs 2025Part 101View 21 CFR 101.22Foods; labeling of spices, flavorings, colorings and chemical preservativesLetters12026 so far0 same vs 2025Part 101View 21 CFR 101.60Nutrient content claims for the calorie content of foodsLetters12026 so far0 same vs 2025Part 101View 21 CFR 101.65Implied nutrient content claims and related label statementsLetters12026 so far0 same vs 2025Part 111View 21 CFR 111.3What definitions apply to this part?Letters12026 so far0 same vs 2025Part 111View 21 CFR 111.16What are the requirements under this subpart C for written procedures?Letters12026 so far0 same vs 2025Part 111View 21 CFR 111.23Under this subpart C, what records must you make and keep?Letters12026 so far0 same vs 2025Part 111View 21 CFR 111.77What must you do if established specifications are not met?Letters12026 so far0 same vs 2025Part 111View 21 CFR 111.303What are the requirements under this subpart J for written procedures?Letters12026 so far0 same vs 2025Part 111View 21 CFR 111.365What precautions must you take to prevent contamination?Letters12026 so far0 same vs 2025Part 111View 21 CFR 111.403What are the requirements under this subpart L for written procedures?Letters12026 so far0 same vs 2025Part 111View 21 CFR 111.410What requirements apply to packaging and labels?Letters12026 so far0 same vs 2025Part 111View 21 CFR 111.455What requirements apply to holding components, dietary supplements, packaging, and labels?Letters12026 so far0 same vs 2025Part 117View 21 CFR 117.20Plant and groundsLetters12026 so far1 +1 vs 2025Part 117View 21 CFR 117.40Equipment and utensilsLetters12026 so far1 +1 vs 2025Part 117View 21 CFR 117.126Food safety planLetters12026 so far0 same vs 2025Part 117View 21 CFR 117.130Hazard analysisLetters12026 so far0 same vs 2025Part 117View 21 CFR 117.139Recall planLetters12026 so far0 same vs 2025Part 117View 21 CFR 117.140Preventive control management componentsLetters12026 so far0 same vs 2025Part 117View 21 CFR 117.145MonitoringLetters12026 so far0 same vs 2025Part 117View 21 CFR 117.150Corrective actions and correctionsLetters12026 so far0 same vs 2025Part 117View 21 CFR 117.160ValidationLetters12026 so far0 same vs 2025Part 117View 21 CFR 117.165Verification of implementation and effectivenessLetters12026 so far0 same vs 2025Part 117View 21 CFR 117.405Requirement to establish and implement a supply-chain programLetters12026 so far0 same vs 2025Part 117View 21 CFR 117.410General requirements applicable to a supply-chain programLetters12026 so far0 same vs 2025Part 117View 21 CFR 117.430Conducting supplier verification activities for raw materials and other ingredientsLetters12026 so far0 same vs 2025Part 165View 21 CFR 165.110Bottled waterLetters12026 so far0 same vs 2025Part 172View 21 CFR 172.345Folic acid (folacin)Letters12026 so far0 same vs 2025Part 172View 21 CFR 172.379Vitamin DLetters12026 so far0 same vs 2025Part 184View 21 CFR 184.1Substances added directly to human food affirmed as generally recognized as safe (GRAS)Letters12026 so far0 same vs 2025Part 184View 21 CFR 184.1950Vitamin DLetters12026 so far0 same vs 2025Part 201View 21 CFR 201.62Declaration of net quantity of contentsLetters12026 so far0 same vs 2025Part 201View 21 CFR 201.122Drugs for processing, repacking, or manufacturingLetters12026 so far0 same vs 2025Part 207View 21 CFR 207.25What information is required for registration?Letters12026 so far1 +1 vs 2025Part 207View 21 CFR 207.53What listing information must a registrant submit for a drug that it repacks or relabels?Letters12026 so far0 same vs 2025Part 211View 21 CFR 211.46Ventilation, air filtration, air heating and coolingLetters12026 so far0 same vs 2025Part 211View 21 CFR 211.103Calculation of yieldLetters12026 so far1 +1 vs 2025Part 211View 21 CFR 211.111Time limitations on productionLetters12026 so far0 same vs 2025Part 211View 21 CFR 211.115ReprocessingLetters12026 so far1 +1 vs 2025Part 211View 21 CFR 211.176Penicillin contaminationLetters12026 so far0 same vs 2025Part 211View 21 CFR 211.204Returned drug productsLetters12026 so far0 same vs 2025Part 211View 21 CFR 211.208Drug product salvagingLetters12026 so far0 same vs 2025Part 212View 21 CFR 212.50What production and process controls must I have?Letters12026 so far0 same vs 2025Part 212View 21 CFR 212.60What requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products?Letters12026 so far0 same vs 2025Part 213View 21 CFR 213.22Responsibilities of quality unitLetters12026 so far1 +1 vs 2025Part 213View 21 CFR 213.82Receipt and storage of incoming designated medical gasesLetters12026 so far1 +1 vs 2025Part 213View 21 CFR 213.165Testing and release for distributionLetters12026 so far1 +1 vs 2025Part 213View 21 CFR 213.192Production record reviewLetters12026 so far1 +1 vs 2025Part 213View 21 CFR 213.198Complaint filesLetters12026 so far1 +1 vs 2025Part 216View 21 CFR 216.23Bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic ActLetters12026 so far0 same vs 2025Part 299View 21 CFR 299.5Drugs; compendial nameLetters12026 so far0 same vs 2025Part 310View 21 CFR 310.502Certain drugs accorded new drug status through rulemaking proceduresLetters12026 so far0 same vs 2025Part 310View 21 CFR 310.527Drug products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss preventionLetters12026 so far0 -1 vs 2025Part 310View 21 CFR 310.530Topically applied hormone-containing drug products for over-the-counter (OTC) human useLetters12026 so far0 same vs 2025Part 312View 21 CFR 312.30Protocol amendmentsLetters12026 so far0 same vs 2025Part 312View 21 CFR 312.33Annual reportsLetters12026 so far0 same vs 2025Part 312View 21 CFR 312.34Letters12026 so far1 +1 vs 2025Part 312View 21 CFR 312.52Transfer of obligations to a contract research organizationLetters12026 so far0 same vs 2025Part 312View 21 CFR 312.58Inspection of sponsor's records and reportsLetters12026 so far0 same vs 2025Part 312View 21 CFR 312.69Handling of controlled substancesLetters12026 so far0 same vs 2025Part 312View 21 CFR 312.305Requirements for all expanded access usesLetters12026 so far0 same vs 2025Part 312View 21 CFR 312.310Individual patients, including for emergency useLetters12026 so far0 same vs 2025Part 314View 21 CFR 314.50Content and format of an NDALetters12026 so far0 same vs 2025Part 314View 21 CFR 314.80Postmarketing reporting of adverse drug experiencesLetters12026 so far1 +1 vs 2025Part 330View 21 CFR 330.3Imprinting of solid oral dosage form drug productsLetters12026 so far0 same vs 2025Part 330View 21 CFR 330.6Letters12026 so far0 same vs 2025Part 349View 21 CFR 349.18Ophthalmic vasoconstrictorsLetters12026 so far0 same vs 2025Part 606View 21 CFR 606.20PersonnelLetters12026 so far0 same vs 2025Part 606View 21 CFR 606.100Standard operating proceduresLetters12026 so far0 same vs 2025Part 606View 21 CFR 606.160RecordsLetters12026 so far0 same vs 2025Part 640View 21 CFR 640.65PlasmapheresisLetters12026 so far0 same vs 2025Part 801View 21 CFR 801.1Medical devices; name and place of business of manufacturer, packer or distributorLetters12026 so far0 same vs 2025Part 801View 21 CFR 801.5Medical devices; adequate directions for useLetters12026 so far0 same vs 2025Part 801View 21 CFR 801.18Format of dates provided on a medical device labelLetters12026 so far0 -1 vs 2025Part 801View 21 CFR 801.87Letters12026 so far0 same vs 2025Part 801View 21 CFR 801.109Prescription devicesLetters12026 so far0 same vs 2025Part 801View 21 CFR 801.119In vitro diagnostic productsLetters12026 so far0 same vs 2025Part 803View 21 CFR 803.11What form should I use to submit reports of individual adverse events and where do I obtain these forms?Letters12026 so far0 -1 vs 2025Part 803View 21 CFR 803.19Are there exemptions, variances, or alternative forms of adverse event reporting requirements?Letters12026 so far0 -1 vs 2025Part 803View 21 CFR 803.53If I am a manufacturer, in which circumstances must I submit a 5-day report?Letters12026 so far0 same vs 2025Part 806View 21 CFR 806.1ScopeLetters12026 so far1 +1 vs 2025Part 806View 21 CFR 806.20Records of corrections and removals not required to be reportedLetters12026 so far0 same vs 2025Part 807View 21 CFR 807.22Times for establishment registration and device listingLetters12026 so far0 -1 vs 2025Part 807View 21 CFR 807.40Establishment registration and device listing for foreign establishments importing or offering for import devices into the United StatesLetters12026 so far0 same vs 2025Part 807View 21 CFR 807.65Exemptions for device establishmentsLetters12026 so far0 -1 vs 2025Part 807View 21 CFR 807.97Misbranding by reference to premarket notificationLetters12026 so far0 same vs 2025Part 812View 21 CFR 812.3DefinitionsLetters12026 so far0 -1 vs 2025Part 812View 21 CFR 812.5Labeling of investigational devicesLetters12026 so far1 +1 vs 2025Part 812View 21 CFR 812.7Prohibition of promotion and other practicesLetters12026 so far1 +1 vs 2025Part 812View 21 CFR 812.20ApplicationLetters12026 so far0 -1 vs 2025Part 812View 21 CFR 812.35Supplemental applicationsLetters12026 so far1 +1 vs 2025Part 812View 21 CFR 812.43Selecting investigators and monitorsLetters12026 so far0 same vs 2025Part 812View 21 CFR 812.110Specific responsibilities of investigatorsLetters12026 so far1 +1 vs 2025Part 812View 21 CFR 812.150ReportsLetters12026 so far0 -1 vs 2025Part 820View 21 CFR 820.35Control of recordsLetters12026 so far1 +1 vs 2025Part 820View 21 CFR 820.65TraceabilityLetters12026 so far0 -1 vs 2025Part 820View 21 CFR 820.130Device packagingLetters12026 so far0 -1 vs 2025Part 820View 21 CFR 820.170InstallationLetters12026 so far0 -1 vs 2025Part 830View 21 CFR 830.50Changes that require use of a new device identifierLetters12026 so far0 same vs 2025Part 830View 21 CFR 830.60Relabeling of a device that is required to bear a unique device identifierLetters12026 so far0 same vs 2025Part 862View 21 CFR 862.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)Letters12026 so far0 -1 vs 2025Part 862View 21 CFR 862.1205Cortisol (hydrocortisone and hydroxycorticosterone) test systemLetters12026 so far0 -1 vs 2025Part 864View 21 CFR 864.6550Occult blood testLetters12026 so far0 same vs 2025Part 864View 21 CFR 864.7280Factor V Leiden DNA mutation detection systemsLetters12026 so far0 same vs 2025Part 868View 21 CFR 868.5470Hyperbaric chamberLetters12026 so far0 same vs 2025Part 868View 21 CFR 868.6810Tracheobronchial suction catheterLetters12026 so far0 same vs 2025Part 870View 21 CFR 870.1025Arrhythmia detector and alarm (including ST-segment measurement and alarm)Letters12026 so far1 +1 vs 2025Part 870View 21 CFR 870.1130Noninvasive blood pressure measurement systemLetters12026 so far0 -1 vs 2025Part 870View 21 CFR 870.5225External counter-pulsating deviceLetters12026 so far0 same vs 2025Part 870View 21 CFR 870.5310Automated external defibrillator systemLetters12026 so far0 same vs 2025Part 872View 21 CFR 872.3590Preformed plastic denture toothLetters12026 so far0 -1 vs 2025Part 872View 21 CFR 872.3660Impression materialLetters12026 so far0 -1 vs 2025Part 872View 21 CFR 872.3760Denture relining, repairing, or rebasing resinLetters12026 so far0 -1 vs 2025Part 876View 21 CFR 876.5020External penile rigidity devicesLetters12026 so far0 same vs 2025Part 876View 21 CFR 876.5220Colonic irrigation systemLetters12026 so far1 +1 vs 2025Part 876View 21 CFR 876.5665Water purification system for hemodialysisLetters12026 so far0 same vs 2025Part 876View 21 CFR 876.5820Hemodialysis system and accessoriesLetters12026 so far1 +1 vs 2025Part 878View 21 CFR 878.4400Electrosurgical cutting and coagulation device and accessoriesLetters12026 so far0 same vs 2025Part 878View 21 CFR 878.4430Microneedling device for aesthetic useLetters12026 so far0 same vs 2025Part 878View 21 CFR 878.4490Absorbable hemostatic agent and dressingLetters12026 so far0 -1 vs 2025Part 878View 21 CFR 878.4590Focused ultrasound stimulator system for aesthetic useLetters12026 so far0 same vs 2025Part 878View 21 CFR 878.4800Manual surgical instrument for general useLetters12026 so far0 same vs 2025Part 878View 21 CFR 878.4810Laser surgical instrument for use in general and plastic surgery and in dermatologyLetters12026 so far0 same vs 2025Part 878View 21 CFR 878.4820Surgical instrument motors and accessories/attachmentsLetters12026 so far1 +1 vs 2025Part 878View 21 CFR 878.5350Needle-type epilatorLetters12026 so far0 same vs 2025Part 880View 21 CFR 880.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)Letters12026 so far1 +1 vs 2025Part 880View 21 CFR 880.2910Clinical electronic thermometerLetters12026 so far0 same vs 2025Part 880View 21 CFR 880.5440Intravascular administration setLetters12026 so far1 +1 vs 2025Part 880View 21 CFR 880.5690Infant supine sleep systemLetters12026 so far1 +1 vs 2025Part 880View 21 CFR 880.5725Infusion pumpLetters12026 so far0 -1 vs 2025Part 880View 21 CFR 880.6430Liquid medication dispenserLetters12026 so far1 +1 vs 2025Part 880View 21 CFR 880.6890General purpose disinfectantsLetters12026 so far0 same vs 2025Part 880View 21 CFR 880.6992Medical washer-disinfectorLetters12026 so far1 +1 vs 2025Part 882View 21 CFR 882.1320Cutaneous electrodeLetters12026 so far0 same vs 2025Part 882View 21 CFR 882.1400ElectroencephalographLetters12026 so far0 same vs 2025Part 882View 21 CFR 882.1460NystagmographLetters12026 so far0 same vs 2025Part 882View 21 CFR 882.1540Galvanic skin response measurement deviceLetters12026 so far0 same vs 2025Part 882View 21 CFR 882.5050Biofeedback deviceLetters12026 so far0 same vs 2025Part 884View 21 CFR 884.5970Clitoral engorgement deviceLetters12026 so far0 same vs 2025Part 886View 21 CFR 886.4250Ophthalmic electrolysis unitLetters12026 so far1 +1 vs 2025Part 886View 21 CFR 886.4350Manual ophthalmic surgical instrumentLetters12026 so far1 +1 vs 2025Part 888View 21 CFR 888.1240AC-powered dynamometerLetters12026 so far0 -1 vs 2025Part 888View 21 CFR 888.2910Letters12026 so far0 same vs 2025Part 888View 21 CFR 888.3410Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesisLetters12026 so far0 same vs 2025Part 890View 21 CFR 890.1175Electrode cableLetters12026 so far1 +1 vs 2025Part 890View 21 CFR 890.1925Isokinetic testing and evaluation systemLetters12026 so far0 same vs 2025Part 890View 21 CFR 890.3475Limb orthosisLetters12026 so far0 same vs 2025Part 890View 21 CFR 890.3900Standup wheelchairLetters12026 so far0 -1 vs 2025Part 890View 21 CFR 890.5525Iontophoresis deviceLetters12026 so far0 same vs 2025Part 890View 21 CFR 890.5550Letters12026 so far0 same vs 2025Part 890View 21 CFR 890.5660Therapeutic massagerLetters12026 so far1 +1 vs 2025Part 890View 21 CFR 890.5850Powered muscle stimulatorLetters12026 so far0 same vs 2025Part 892View 21 CFR 892.2050Medical image management and processing systemLetters12026 so far0 -1 vs 2025Part 1002View 21 CFR 1002.10Product reportsLetters12026 so far0 -1 vs 2025Part 1002View 21 CFR 1002.13Annual reportsLetters12026 so far0 -1 vs 2025Part 1002View 21 CFR 1002.20Reporting of accidental radiation occurrencesLetters12026 so far0 same vs 2025Part 1002View 21 CFR 1002.30Records to be maintained by manufacturersLetters12026 so far0 -1 vs 2025Part 1003View 21 CFR 1003.2Defect in an electronic productLetters12026 so far0 same vs 2025Part 1003View 21 CFR 1003.10Discovery of defect or failure of compliance by manufacturer; notice requirementsLetters12026 so far0 same vs 2025Part 1003View 21 CFR 1003.20Notification by the manufacturer to the SecretaryLetters12026 so far0 same vs 2025Part 1010View 21 CFR 1010.3IdentificationLetters12026 so far0 -1 vs 2025Part 1020View 21 CFR 1020.31Radiographic equipmentLetters12026 so far0 same vs 2025Part 1040View 21 CFR 1040.10Laser productsLetters12026 so far0 -1 vs 2025Part 1040View 21 CFR 1040.20Sunlamp products and ultraviolet lamps intended for use in sunlamp productsLetters12026 so far1 +1 vs 2025Part 1271View 21 CFR 1271.4Letters12026 so far0 -1 vs 2025Part 1271View 21 CFR 1271.6Letters12026 so far1 +1 vs 2025Part 1271View 21 CFR 1271.160Establishment and maintenance of a quality programLetters12026 so far0 same vs 2025Part 1271View 21 CFR 1271.180ProceduresLetters12026 so far0 same vs 2025Part 1271View 21 CFR 1271.190FacilitiesLetters12026 so far0 same vs 2025Part 1271View 21 CFR 1271.200EquipmentLetters12026 so far0 same vs 2025Part 1271View 21 CFR 1271.210Supplies and reagentsLetters12026 so far0 same vs 2025Part 1271View 21 CFR 1271.215RecoveryLetters12026 so far0 same vs 2025Part 1271View 21 CFR 1271.250Labeling controlsLetters12026 so far0 same vs 2025Part 1271View 21 CFR 1271.260StorageLetters12026 so far0 same vs 2025Part 1271View 21 CFR 1271.270RecordsLetters12026 so far0 same vs 2025Part 1271View 21 CFR 1271.290TrackingLetters12026 so far0 same vs 2025Part 1271View 21 CFR 1271.320Complaint fileLetters12026 so far0 same vs 2025Part 1308View 21 CFR 1308.13Schedule IIILetters12026 so far0 same vs 2025ISO 13485View ISO 13485 4.1.4Letters12026 so far1 +1 vs 2025ISO 13485View ISO 13485 6.3InfrastructureLetters12026 so far1 +1 vs 2025ISO 13485View ISO 13485 6.4.1Work environmentLetters12026 so far1 +1 vs 2025ISO 13485View ISO 13485 7.4.2Purchasing informationLetters12026 so far1 +1 vs 2025ISO 13485View ISO 13485 7.5.6Validation of processes for production and service provisionLetters12026 so far1 +1 vs 2025ISO 13485View ISO 13485 8.2.6Monitoring and measurement of productLetters12026 so far1 +1 vs 2025ISO 13485View ISO 13485 8.3.1GeneralLetters12026 so far1 +1 vs 2025ISO 13485View ISO 13485 8.3.4ReworkLetters12026 so far1 +1 vs 2025
No regulation matches. Clear the search or pick another Part.