21 CFR 820.50
Purchasing controls
21 CFR 820.50 is the regulation titled “Purchasing controls” in 21 CFR Part 820, Quality System Regulation (before Feb 2, 2026). Since 2021, 49 FDA warning letters have cited it.
Part 820 changed when FDA's Quality Management System Regulation took effect on February 2, 2026. This is the earlier text these letters cite.
- Letters citing it
- 49 since 2021
- Jan 1 to Oct 30, 2026
- 7 against 15 on the same dates in 2025
- Most often cited with
- 21 CFR 820.30, in 40 letters
- Closed out
- 14% of these letters have a published close-out
Letters citing it, by year issued
Most are medical device letters (48 of 49). 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 820.50 most often, as written in the letters.
- 4 lettersFailure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50
- 2 lettersFailure to adequately establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50
- 2 lettersFailure to adequately establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50
The regulation
Read the text of 21 CFR 820.50 (eCFR, as of Jun 1, 2025)
Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.
(a) Evaluation of suppliers, contractors, and consultants. Each manufacturer shall establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. Each manufacturer shall:
(1) Evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation shall be documented.
(2) Define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results.
(3) Establish and maintain records of acceptable suppliers, contractors, and consultants.
(b) Purchasing data. Each manufacturer shall establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services. Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device. Purchasing data shall be approved in accordance with § 820.40.
Text from eCFR as of Jun 1, 2025.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 820.50.
- 21 CFR 820.30Design controls40 letters cite both
- 21 CFR 820.100Corrective and preventive action35 letters cite both
- 21 CFR 820.198Complaint files34 letters cite both
- 21 CFR 807.81When a premarket notification submission is required26 letters cite both
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?20 letters cite both
- 21 CFR 820.80Receiving, in-process, and finished device acceptance20 letters cite both
- 21 CFR 820.90Nonconforming product19 letters cite both
- 21 CFR 820.22Quality audit18 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 820.50 that FDA posted most recently.
- DevicesView Chirp Innovations, LLCChirp Halo Wireless Muscle StimulatorIssuedOct 2, 2026PostedOct 27, 2026
- DevicesView Peter Schiff Enterprisescardiac electrode pads and AC cardiac fibrillatorsIssuedAug 26, 2026PostedOct 27, 2026
- DevicesView Olympus Medical Systems CorporationSurgical and endotherapy devices including clips, sphincterotomes, cystoscopes, bronchoscopes, and insufflators.IssuedOct 7, 2026PostedOct 20, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.