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Amendments for High Risk Device Type Regulatory Pathway

BayBiotech.NET
Government Accounting Office (“GAO”) has issued a long-awaited report evaluating the use of the 510(k) process by the Food and Drug Administration (“FDA” or the “Agency”) in the January of 2009. Report mainly focused on Preamendment class III devices.

Although most high-risk class III medical devices are subject to the demanding premarket approval (“PMA”) process, preamendment class III devices may be cleared through the 510(k) pathway until FDA issues regulations requiring a PMA. Under the Safe Medical Devices Act of 1990, FDA was required either to reclassify preamendment class III devices into class I or II, or (2) issue regulations requiring PMA approval for the devices, GAO noted that 20 preamendment class III device types have not yet been addressed by the Agency.

GAO has urged FDA to take required steps to address the remaining class III devices that continue to be eligible for 510(k) review.

As a result of the report, FDA has committed to address all remaining preamendment class III devices for which 510(k) review is currently permitted. These devices will be reclassified either into class I or class II, or PMA submissions will be required.

Thus, going forward, companies that currently market 510(k) cleared class III devices may be required to file PMA submissions, if FDA determines that their products should remain in class III.

Reference:
United States Government Accountability Office, Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process, January 15, 2009, available athttp://www.gao.gov/new.items/d09190.pdf (GAO report).

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