US FDA re-tackles device changes needing a new 510(k)
This article was originally published in Clinica
Executive Summary
The controversial issue of what types of changes made to medical devices already on the US market would warrant a new pre-market notification or 510(k) application is to be discussed at a public meeting organized by the US Food and Drug Administration on 13 June.
The controversial issue of what types of changes made to medical devices already on the US market would warrant a new pre-market notification or 510(k) application is to be discussed at a public meeting organized by the US Food and Drug Administration on 13 June.
Though the FDA issued a draft guideline on this topic in July 2011, the FDA Safety and Innovation Act requires the agency to withdraw the document in light of concerns from industry that enforcement of the guideline could lead to a 300-500% increase in new 510(k)s (www.clinica.co.uk, 27 October 2011). FDASIA also gives the agency 18 months to submit a report on this topic to two congressional committees – Senate's Committee on Health, Education, Labor and Pensions (HELP) and House of Representatives' Committee on Energy and Commerce.
Feedback from the public meeting will be used to formulate the FDA's report to Congress, as well as any future guidance on this topic. Specifically, the FDA is looking for feedback on how:
- risk management can be used appropriately and consistently in deciding whether a device modification requires a new 510(k) submission;
- design control activities, such as design verification and validation, can be utilized to ensure that device modifications are appropriately evaluated prior to marketing;
- critical specifications – a new concept – can be used to make decisions on whether a 510(k) is required for a device modification easier. Under this approach, if the FDA and manufacturers can identify essential device specifications – critical specifications –and can agree on limits and testing protocols for those specifications within a 510(k), then a device manufacturer may make modifications to a device, and as long as the resulting device remains within the agreed-upon limits for all of the critical specifications, no new 510(k) would be required for that modified device;
- device types can be stratified using a risk-based approach for 510(k) modification purposes (eg requiring a 510(k) for modifications made to higher-risk devices and for only certain modifications made to low-risk devices); and
- periodic reporting can be used for modified devices that do not require a new 510(k) submission.
In addition, the FDA is seeking specific examples of device changes that device manufacturers may have made to their products that should not trigger the requirement for a new 510(k) submission, with explanations as to why a 510(k) submissions should not be required.
Stakeholders can also submit written comments on this topic until 13 July regardless of whether or not they attend the public meeting, which will be held at the FDA's White Oak Campus in Maryland.