We recently seen a new initiative from the FDA. The FDA seems to be reaching out to medical device companies that have been listing devices within the registration process that they are claiming to be covered under the device “pre-amendment” status. This is a very NEW initiative from the FDA and the first time we have seen this concern from the Agency.
The following is a copy of the letter that one of mdi’s clients recently received (all confidential information was removed):
“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):
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 firstname.lastname@example.org 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 email@example.com with a rationale and the amount of additional time you are requesting.
For questions regarding this letter, please contact us at firstname.lastname@example.org.
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.
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))”.
We suspect that there are not many companies still marketing their pre-amendment devices. However, those companies that are, they must now do a critical review to determine the impact of various changes made over the life time of their device. The review must be done in accordance with the 21 CFR 807.81(a)(3) and FDA’s guidance “Deciding When to Submit a 510(k) for a Change to an Existing Device”.
Even if it is determined there has not been a major change or modification in the intended use of the device and/or changes that could significantly affect the safety and effectiveness of the device, this conclusion needs to be submitted to FDA electronically within 30 days of the receipt of the above letter.
If a company determines their device no longer qualifies for preamendment status because of a major change or modification, the submission of a 510(k) or other premarket submission is required for each such device. FDA warns companies to compare the currently marketed version of a preamendment device to the original preamendment version of the device. The cumulative changes made to a preamendment device over time can aggregate and trigger the requirement to submit a 510(k) or other premarket submission.
It is important to get in touch with the Agency within 30 days of receipt of the above letter and discuss a 510(k) submission plan if more than 30 days are needed.
With the annual registration period (October 1, 2023 through December 31, 2023) shortly approaching, the companies marketing preamendment devices need to take notice they will no longer be able to simply list their devices when renewing the FDA registration.
They will need to attest to FDA in writing their currently marketed device version was reviewed against the original preamendment device version and no changes/modifications in the intended use or changes/modifications affecting the device safety and effectiveness were identified.
Alternatively, if the device’s currently marketed version is different from its original preamendment version in the intended use 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.
mdi has assisted 100s of companies over the 45 years we have been in business with review of their device changes and determination whether a new 510(k) or another submission is required. If you would like our assistance in reviewing your pre-amendment devices status and/or the changes you have made to your devices, please contact mdi at: email@example.com and RE: pre-amendment status.