PMA Methods- Streamlined PMA

The streamlined PMA is a pilot program in the Division of Clinical Laboratory Devices. A complete PMA is submitted as in a traditional PMA; however, the Streamlined PMA is for a device in which the technology and use are well known to FDA. A Streamlined PMA review may be appropriate for PMAs when there is either:

• an FDA guidance document or other published methods for review which have been evaluated by FDA, or
• an FDA review history dealing with like products (two or more of a kind)

During the protocol and PMA review, the sponsor must be available for an interactive review process. Ideally, prior to beginning studies to determine the safety and effectiveness of the product to be included in this pilot program, the sponsor would submit its protocol for FDA review. Familiarity with the product and protocol as part of this up-front evaluation should streamline the review of the PMA once filed.