FDA 510(k) Pre-Market Review Latest News

September 10, 2010

By Sparta Editorial


Key Highlights of FDA 510(k) Reform

The FDA has recently released two comprehensive internal reports regarding potential 510(k) reform, including recommendations, and is seeking public comments thru October 4, 2010. Also, there was a live webinar with the agency to respond to questions from the industry.

See the following link for webinar information as well as the reports: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm220272.htm.

Some highlights include:

  1. A major focus is ”enhancing regulatory predictability.” The industry has been reporting that the FDA review process is inconsistent and not transparent; these recommendations are designed to improve on such. One example is providing clarity around what determines if a device is “substantially equivalent” – which is the basis of the 510(k) process.

  2. A new requirement to explicitly require more complete safety and effectiveness information as part of the 510(k) process.

  3. The FDA is proposing a stronger online database for patients and healthcare providers to search for devices – including schematics and photographs. The theory is that it will help each make more informed decisions by strengthening what is available online, such as determining what device is appropriate for a patient or helping device manufacturers effectively study/improve upon predicate devices.

These proposals are designed to help improve patient safety while providing a platform for companies to invest in new products. The initial reaction I’ve been hearing has been quite positive on the “enhancing regulatory predictability” side, while concerns have been raised about the risk of exposing too much intellectual property as part of the enhanced device database.

Time will tell how these proposals proceed, but certainly change is in the air for the 510(k) process.

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