Minn. group aims to reverse changes to 510(k) process

01/7/2013 | MedCityNews.com

The Minnesota Medical Device Alliance has filed a petition asking the FDA to discontinue certain definitions and administrative measures that the group says unlawfully alter the 510(k) clearance process. The petition cites practices adopted by the FDA since 2009, including wrongly applying "assurance case" and risk mitigation principles to 510(k) criteria.

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