FDA to Guide Device Makers on Marketing Application

FDA plans to provide medical device makers feedback before they apply for marketing approval to help companies identify regulatory requirements early in the device development process.

The new program, called Pre-Sub, was introduced one day after the Congress passed the FDA User Fee Reauthorization Bill.

A similar process, called a Special Protocol Assessment, already exists for drugs and medicines, in which FDA and drugmakers agree upon a specific design and main goals for a clinical study. The drugmaker receives guidance on the marketing application for the drug, reducing chances of rejection after review.

FDA is seeking public comment on the Pre-Sub draft guidance.


REFERENCE

FDA to guide device makers on marketing application. Reuters, July 12, 2012.