FDA Establishes Pre-Market Approval Pilot Program

As part of its effort to streamline the approval process for high-risk medical devices, the U.S. Food and Drug Administration (FDA) has announced a new pilot program that will eliminate pre-market approval inspections.

According to a Notice published in the Federal Register on September 12, the pilot program will commence in late September and will include up to nine PMA registrants. PMA applicants who are selected to participate in the pilot program will not be subject to pre-market approval inspections, but instead will submit to post-approval inspections that will focus on design, manufacturing and quality assurance practices.

Read the complete text of the Notice of the FDA’s pilot program, which includes information on how to apply to participate.

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