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FDA kills it; records highest PMA approval rate in this century

FDA gets a lot of flak from the medical device industry for its slow, heavy handed approach to the regulatory approval process. Rather than grin and bear it, medtech manufacturers have adopted a Europe-first strategy for many years now to take advantage of a more predictable pathway to market for new medical technologies. FDA, it seems, is fighting back: The agency claims to have approved 98% of all high-risk medical devices submitted during the most recent fiscal year, the highest rate in at least 15 years, reports the Chicago Tribune.

Norbert Sparrow

December 2, 2015

1 Min Read
FDA kills it; records highest PMA approval rate in this century

These devices were submitted through FDA's premarket approval program, which it describes as the "most stringent regulatory process" at the Center for Devices and Radiological Health, which is tasked with regulating medical devices within the agency.

FDA also reports that it has improved its record for 510(k) premarket notifications, which involve devices that are "substantially equivalent" to a device that is currently on the market. The agency says that it has cleared 85% of all applications in fiscal year 2015, its highest rate since 2010, reports Med Device Online. FDA also says that it accelerated clearance of 510(k) applications from 126 days on average in 2014 to 95 days in 2015.

Is this a welcome trend or simply a one-off? It is worth noting that FDA has come under consistent criticism from industry and some legislators for its cumbersome approval process. Consequently, the agency has vowed to implement internal reforms and accelerate the approval process. Perhaps, we are seeing the fruits of those efforts.

About the Author(s)

Norbert Sparrow

Editor in chief of PlasticsToday since 2015, Norbert Sparrow has more than 30 years of editorial experience in business-to-business media. He studied journalism at the Centre Universitaire d'Etudes du Journalisme in Strasbourg, France, where he earned a master's degree.


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