Neitz Instruments Company Ltd.

During an inspection of your firm located in Ichibancho, Japan on May 15, 2023, through May 19, 2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Neitz Halogen Ophthalmoscope BXa, 13A Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.

Our inspection revealed that your firm’s devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:

Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17

For example, during the inspection, the following documents were presented as your firm’s MDR procedure.

“Complaint Handling Procedure”, (b)(4), dated 5/27/2022

“Post-market Safety Control Operating Procedure”, (b)(4), dated 11/28/2022

“Corrective Action Procedure”, No Document Number, (b)(4), dated 6/30/2022

“Recall Procedure for Overseas Market”, (b)(4), dated 3/13/2023

After collectively reviewing these documents, we determined that they do not contain information that would indicate that your MDR procedures created in accordance with the requirements in 21 CFR 803.17. Specifically,

1. The procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, as required by 21 CFR 803.17(a)(1). For example:

a. There are no definitions of what your firm will consider to be a reportable event under 21 CFR Part 803. The exclusion of definitions from 21 CFR 803.3 for the terms “become aware,” “caused or contributed,” “malfunction,” “MDR reportable event,” and “serious injury,” and the definition for the term “reasonably suggests,” found in 803.20(c)(1) may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a). b. The procedure does not include instructions for how your firm will evaluate information about an event to make MDR reportability determinations in a timely manner.

2. The procedure does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part, as required by 21 CFR 803.17(a)(2). For example,

a. There are no instructions for conducting an investigation of each MDR reportable event and evaluating the cause of the event. b. The procedure, as written, does not specify who makes the decision for reporting events to FDA.

3. The procedure does not establish internal systems that provide for timely transmission of complete medical device reports, as required by 21 CFR 803.17(a)(3). Specifically, the procedure does not include:

a. Instructions for how to obtain and complete the FDA 3500A form. b. The circumstances under which your firm must submit initial (30 day) reports, supplemental/follow-up reports, or 5-day reports, and the requirements for such reports. c. A process for submitting initial and supplement or follow-up reports to FDA in an electronic format that FDA can process, review and archive in accordance with 21 CFR 803.12(a); d. How your firm will ensure that all information reasonably known to you is submitted for each event. Specifically, which sections of the Form 3500A will need to be completed to include all information found in your firm’s possession and any information that becomes available as a result of a reasonable follow-up within your firm.

4. The procedure does not describe how your firm will address documentation and recordkeeping requirements, as required by 21 CFR 803.17(b), including: a. Documentation of adverse event related information maintained as MDR event files. b. Information that was evaluated to determine if an event was reportable. c. Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable, as required under 21 CFR 803.18(b)(1)(i).

Additionally, based on our records, as of July 14, 2023, there is no evidence that your firm established an active Electronic Submissions Gateway (ESG) production account for the electronic submission of MDR reports. Information about the ESG can be found at: How to Enroll in eMDR Program | FDA.

We reviewed your firm’s response dated June 16, 2023 and conclude that it is not adequate. The response notes that your firm is in the process of revising its procedures to incorporate the requirements of 21 CFR 803.17. Specifically, while it includes an excerpt of its revised procedure titled “Complaint and Quality Information Handling Procedure”, Rev. 14, and Section 5.3, which incorporates the definitions from 21 CFR 803.3 for the terms “MDR reportable event” and “serious injury,” it does not include additional definitions listed above. Furthermore, the additional deficiencies previously listed have not been addressed in your firm’s response.

Other federal agencies may take your compliance with the FD&C Act and its implementation regulations into account when considering the award of federal contracts

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective action (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review. We will notify you regarding the adequacy of your firm’s response(s) and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent via email to CDRHWarningLetterResponses@fda.hhs.gov or by mail to Food and Drug Administration, Center for Devices and Radiological Health, Office of Regulatory Programs, Division of Regulatory Programs 2, FDA Regulatory Inspections and Audits Team, White Oak Building 66, 10903 New Hampshire Ave., Silver Spring, MD 20993. (Refer to CMS case # 664336 when replying). If you have any questions about the contents of this letter, please contact: Elvin Ng at 240-402-6195 or Elvin.Ng@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.