FDA ADDRESSES the PRE-AMENDMENT DEVICE STATUS

“Dear “Medical Device Manufacturer”

The Food and Drug Administration (FDA) is reaching out to all companies who have listed one or more preamendment devices within the registration process to remind registrants of the factors for determining preamendment status and to request additional listing information under 21 CFR 807.26 related to the continued preamendment status of any such device listed.

According to our records, you are currently marketing the following device(s) without a premarket notification (510(k)) and are claiming preamendment status as a rationale for not using a cleared 510(k) or other marketing authorization to list your device(s):

• DXXXXXXX

On May 28, 1976, Congress enacted the Medical Device Amendments (MDA) to the Federal Food, Drug, and Cosmetic (FD&C) Act, 21 U.S.C. §§ 360c-360k, which set forth a detailed system for classification and premarket review and authorization of medical devices. The MDA did not require any premarket review for preamendment devices, which are devices that were legally marketed in the U.S. by a particular firm before May 28, 1976, and which have not been significantly changed or modified since May 28, 1976, and for which a regulation requiring an application for premarket approval (PMA) has not been published by FDA. Devices meeting the above criteria qualify for preamendment status and do not require premarket authorization. However, if there has been a major change or modification in the intended use of the device or the device has been changed or modified in a way that could significantly affect safety or effectiveness (e.g., a significant change or modification in design, material, chemical composition, energy source or manufacturing process), a 510(k) or other marketing authorization must be submitted to FDA. See section 510(k) of the FD&C Act (21 U.S.C. § 360(k)); 21 CFR 807.81.¹

We appreciate that over the course of four decades, changes may have been made to a preamendment device that, in the aggregate over time, could trigger the requirement to submit a 510(k) or other premarket submission.

At this time, we request that you review all preamendment devices you are currently marketing and compare the currently marketed version of [the device / each device listed above] to the preamendment version of each device using the regulatory criteria outlined in 21 CFR 807.81(a)(3).²

Please remember that manufacturers may make a number of changes without having to submit a new 510(k),³ but each time a change is made, the newly modified device should be compared to the original marketed preamendment device. When the cumulative effect of individual changes triggers the regulatory threshold for submission, the manufacturer should submit a new 510(k) or other premarket submission and receive marketing authorization prior to introducing such product into the marketplace.

If you conclude based on your review that your current device(s) continue to qualify for preamendment status, then FDA specifically requests, pursuant to 21 CFR 807.26(e)(4), additional listing information in the form of a statement of the basis upon which you have determined that such devices are not subject to section 514 or 515 of the FD&C Act. We recommend that your statement include that you have reviewed the requirements in 21 CFR 807.81(a)(3) and FDA’s guidance “Deciding When to Submit a 510(k) for a Change to an Existing Device” and determined that there has not been a major change or modification in the intended use of the device and that no changes or modifications have been made to the device that could significantly affect the safety and effectiveness of the device. Please submit this information electronically to the Device Determination program mailbox at devicedetermination@fda.hhs.gov within 30 days of the receipt of this letter.

Otherwise, if you conclude based on your review that your current device(s) no longer qualify for preamendment status because there has been a major change or modification in the intended use of the device or the device has been changed or modified in a way that could significantly affect safety or effectiveness (e.g., a significant change or modification in design, material, chemical composition, energy source or manufacturing process), the submission of a 510(k) or other premarket submission is required for each such device. In such cases and where we have not yet received a submission, the firm is welcome to discuss with the Agency a proposed plan for submission and FDA review of your device(s) within a reasonable timeframe.

If you require additional time beyond 30 days to complete your review, please send an email to devicedetermination@fda.hhs.gov with a rationale and the amount of additional time you are requesting.

For questions regarding this letter, please contact us at devicedetermination@fda.hhs.gov.

Sincerely,

XXXX
Director
Division 1: Division of Submission Support
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Food and Drug Administration

¹For further information on deciding when to submit a 510(k) for a change to an existing device, please review our guidance titled “Deciding When to Submit a 510(k) for a Change to an Existing Device” at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device.
²Ibid.
³Regardless of whether a change requires premarket review, the QS regulation requires manufacturers of finished medical devices to review and approve changes to device design and production (21 CFR 820.30 and 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Any process whose results cannot be fully verified by subsequent inspection and testing must be validated (21 CFR 820.75), and changes to the process require review, evaluation, and revalidation of the process where appropriate (21 CFR 820.75(c))”.