510(k) clearance

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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 Read more

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