Riegel v Medtronic

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Gateway FDA: The New 510 (k) Guidance: A Product Liability Perspective, Gateway FDA, August 26, 2011

This August 26, 2011 blog on Gateway FDA is written for the medical device industry and its lawyers. The FDA recently issued new draft guidelines so manufacturers understand how to comply with the controversial 510(k) fast-track approval for marketing of their medical device. The new guidelines replace the 1997 guidelines [...]

By |2011-08-26T22:52:14-04:00August 26th, 2011|FDA News, Media Reports|0 Comments