Varun Saxena from fiercemedicaldevices.com wrote an interesting article on the proposed plan of Expedited Access PMA (EAP). The FDA talked about how EAP is not a new path to market but a collaborative approach to facilitate product development under existing FDA guidelines. It is targeted for a very specific type of high-risk medical devices and allows the company to interact early and on a regular basis with FDA. Quoted in the article was CDRH Director Jeffrey Shuren, “We are excited to offer a proposed program for expedited access for certain high-risk medical devices.” To read the full article click here.
