AdvaMed urges FDA to make minor 510(k) changes

The Advanced Medical Technology Association is urging the FDA to move forward with changes to the premarket review program for low- and moderate-risk medical devices "in a way that builds on the strengths of the current program." In comments submitted to the FDA in response to its release of more than 60 proposals to change the 510(k) process, the association expresses concern that the number and scope of the changes could have a negative impact on the agency's mission to ensure patients have access to safe and effective medical technologies.

The association has pushed against a major overhaul, saying the process works well and needs only modest updating, the Wall Street Journal notes. Last month, the AdvaMed pointed to a report--conducted by an outside group with association backing--showing only a small number of devices approved through the 510(k) process since 1998 were involved in serious recalls.

"[W]e are concerned that the cumulative effect of the multiple CDRH proposals in the two reports would result in a revolutionary change in both the 510(k) process and in the larger regulatory framework and may adversely affect the ability of CDRH to effectively carry out mission-critical functions, including timely reviews. Wholesale changes to the program will also impact industry's ability to efficiently bring new devices to market," AdvaMed says in its comments.

The system is relied upon heavily by big device companies like Zimmer Holdings and Johnson & Johnson. But, as the WSJ notes, the FDA is reviewing the 510(k) rules amid criticism that they have been too lax and inconsistently applied. Public Citizen, for example, said the process "has failed to keep dangerous and ineffective medical devices from the market."

- see AdvaMed's release
- check out the association's comments
- read the WSJ report