AdvaMed Says FDA Should Stick with 1997 Guidance for 510(k) Changes

AdvaMed says that a 1997 FDA guidance document on submitting a 510(k) for a change to an existing device, combined with the Quality System Regulation, gives both the agency and industry a strong foundation for determining when a premarket notification should be submitted for a modification or change to a legally marketed device. The association provided its opinion in a whitepaper submission to FDA with industry’s analysis and conclusions on the issue.

The trade association’s paper questions whether there is a real problem that needs to be solved. It notes that the 1997 guidance has given manufacturers a “consistent, predictable tool to assist their assessment of when submissions are needed for device modifications” for 16 years and asserts that there is no indication of any widespread or systemic misuse of the guidance that would lead to a significant departure from it.

FDA’s 2011 draft guidance on deciding when to submit a 510(k) for a change to an existing device significantly departs from the agency’s historical approach to device modification in several key aspects, AdvaMed says. It says that three modifications to the 1997 guidance could meet many of FDA’s current concerns:

In its comments on the draft guidance, the 510(k) Coalition says there is no pressing public health issue to mandate any significant change. “In addition,” it says, “no safety issue appears to derive from these changes. An examination of Class 1 recalls, for example, does not identify any significant number or pattern of product safety issues relating to a failure to submit a new 510(k) for a device modification.”

In other comments, Europe-based 510(k) Consulting Services said FDA should require device company CEOs to sign the document containing the periodic reporting for modifications to 510(k)-cleared devices that do not require new 510(k) submissions (i.e. the Annual Report) under the penalty of perjury.

“If not,” it cautions, “then many companies will be tempted to not be truthful in including all of their modifications, especially the memo-to-file modifications that they did in order to avoid going through a 510(k) in the first place. Currently, many companies will pursue a 510(k) for a new device, but only include the most basic and safe features of that new device, with the 510(k) application. Medical device companies, especially here in Europe, are very intimidated by the 510(k) process and only want to do as few 510(k) submissions as possible. They believe that if they add too many features which are not completely safe and tested, then the FDA will simply never grant them the 510(k) clearance for their device or force them to lower their claims.”