FDA Announces Change to Medical Device Review Process

The Food and Drug Administration released a draft guidance Tuesday that explains what types of changes to a previously approved device would require the manufacturer to submit a new request for approval.

The guidance affects devices cleared through the 510(k) process, which is the review pathway for lower-risk medical devices and the way that most are approved for use in the United States. Manufacturers have to show that a new or modified device is substantially equivalent to another medical device that has already been approved for sale. Manufacturers often make changes to a product after FDA approval.

The draft guidance comes a few days before a more significant development affecting the industry will be announced. The Institute of Medicine is expected to release July 29 a report recommending several changes to the 510(k) process that were so controversial that the FDA asked the IOM to weigh in.

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