By Joe Rotino, VP of Quality and Regulatory Affairs at Pro-Dex

September 29, 2011

1 Min Read
Conquering the 510(k) Mountain

An important quote that came out of the AdvaMed panel, “Impact of 510(k) Review Process Changes” was:

“No mountain is insurmountable when you have the right approach.”


This appropriate, and timely statement was given by John Linehan, Professor of Biomedical Engineering at Northwestern University. Linehan is one of two investigators of a comprehensive analysis of the 510(k) process.


Over 355 people responded to this comprehensive survey which took 90 minutes per person to complete.


When asked, 45 percent of respondents said that, in the last three years, they’ve changed the way they’ve been approaching R&D in relation to the 510(k) process.


The study showed that, as a whole, the industry doesn’t mind changing their processes if they are clear about what it is they are expected to do—currently, they are not.


For example, when asked about the documents required and the FDA review, 7 out of 10 respondents perceived conflicting differences.


Another issue is a change in reviewers. 1 out of 5 smaller companies said that their 510(k) reviewer changed during the process and perceived this to be a hardship.


The study reveals even more insightful information, but the bottom line is that there’s a lot of confusion associated with the 510(k) process—reform or no reform.


The current attempt to upgrade it is appreciated, but there needs to be a better balance between a medical device review process that consumers are vocally concerned about and a 510k process that the MedTech industry thinks is fine as-is.


Comprehensive and practical patient safety and guidance are important, but ineffective if they place U.S. OEM’s and their suppliers at a disadvantage.

Mountain image from the National Archives.

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