Sponsored By

FDA is changing how manufacturers determine whether a cleared device requires a new clearance. Device industry lobbying group would like things to remain the same.

June 13, 2013

3 Min Read
AdvaMed's Message to FDA on 510(k) Modification Guidance: Change is Not Good

The FDA is scheduled to deliver information to Congress in January on how to change the guidance to medical device companies with respect to whether modifications to a cleared device would require a new 510(k) application.

The issue is contentious because what constitutes a big enough change to warrant a new 510(k) application is viewed differently by the agency and the industry. FDA is holding a public meeting Thursday to gather input before it issues a final guidance document.

But on Wednesday, in advance of the meeting, AdvaMed issued a white paper and held a conference call with reporters with an overarching message: changing the way things have been done is not good. Representatives from two member companies, who participated in developing the white paper, also joined the call.

"We believe that the FDA holds a rich and robust regulatory legacy from which to draw," said Tamima Itani, Vice President, Global Regulatory Affairs at Boston Scientific, on the call, referring mainly to a 1997 document in which FDA formalized the requirements for when a new 510(k) would be needed. "The 1997 guidance document has been in existence and used for over 16 years now, providing manufacturers with a consistent, predictable tool to assist their assessment of when submissions are needed for device changes.

Itani added that in developing the white paper, AdvaMed conducted a comprehensive analysis of past documents noting that the review "did not reveal any systemic public health issue or systemic compliance issues that would indicate that the current issue is not robust or does not work. 

The issue goes back to 2011 when the FDA issued a proposed revision to the 1997 guidance document for when a change to a cleared medical device would require the manufacturer to file for a premarket notification or a 510(k).

"It appeared to lower the threshold as to when a change resulted in a need for a new 510(k) submission," said Janet Trunzo, AdvaMed's senior executive vice president, Technology and Regulatory Affairs, on the call Wednesday. "It had the potential to triple the number of 510(k) submissions that the FDA receives. It also shifted the decision making from the company to the reviewer."

Ultimately, FDA withdrew the draft regulation and reinstated the 1997 modifications guidance document, Trunzo said. But changes are coming nevertheless because of a Congressional requirement for FDA to revise the current 510(k) modification policy.

Given that change is inevitable, AdvaMed provided the following recommendations to the FDA hoping that they are incorporated in the final guidance document. As explained by Danelle Miller, Legal Counsel, Global Quality and Regulatory Affairs, Roche Diagnostics, they are:

  • Add an explicit requirement in the final document that when a change is made to a specification, a method, a procedure of a cleared device, a manufacturer should evaluate the change under the established procedures to determine if a submission of a 510(k) is needed. 

  • To require manufacturers to retain records of these evaluations and the results that would help the FDA to inspect the records during routine inspections. This exists in the current document but can be strengthened, Miller said.

  • Add an explicit requirement in the final document such that manufacturers leverage existing quality system procedures that ensure changes to the device design are reviewed, validated, verified as appropriate, and approved

  • Decisions related to “significantly affecting safety and effectiveness” be based on the results of validation (or verification testing when applicable) undertaken in compliance with the QSR (quality systems regulation."

-- By Arundhati Parmar, Senior Editor, MD+DI

Sign up for the QMED & MD+DI Daily newsletter.

You May Also Like