FDA Plans to Issue Earlier Warnings Associated with Risky Medical Devices

Posted by Sarah Showard | Jan 07, 2016 | 0 Comments

The move to take a more aggressive posture in reporting potential risks with medical devices follows several high profile lawsuits involving the safety and risks of medical products. Among them a hip implant, a defibrillator that stopped working, and a mesh implant to prevent incontinence in women, which has been reported to erode. The FDA has an established system of issuing public warnings, however they have historically waited to release information until after analyzing adverse events, of which hundreds of thousands are submitted each year.

About the Author

Sarah Showard

Sarah Showard graduated from the University of Maryland in 1985, Magna Cum Laude with a Bachelor of Arts in English-Linguistics and a Certification in Womens Studies. She then graduated from New York University School of Law in 1988. Sarah began practice initially as an insurance defense attorne...


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