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FDA’s 510(k) Clearance Does NOT Lead to Safer Gyn Medical Devices

Mesh Medical Device News Desk, April 11, 2018 ~ The Food and Drug Administration's 510(k) clearance process for medical devices has been called a fast-track to market clearance process. This study reveals it does not lead to safer gynecologic medical devices. FDA Approval of Gynecologic Medical Devices Image: Desara mesh by [...]

By |2018-06-05T11:11:01-04:00April 11th, 2018|FDA News|0 Comments

FDA Follows Industry Lead to Shorten Time to Market

October 30, 2012 ~    The FDA has issued the new rules for medical device makers to speed up the time it takes for medical devices to make it to market. Earlier this year industry agreed to pay $595 million over 5 years to the FDA as part of its [...]

By |2012-10-31T00:27:06-04:00October 31st, 2012|FDA News|1 Comment