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What Does the Future Hold for FDA's Clearance Process and How Does it Impact Medical Device Companies?

16 November 2010

Webinar Recording
If you were unable to join us for the original presentation on Tuesday, November 16, 2010, you may access the webinar recording and presentation materials below:

Program Overview
The U.S. Food and Drug Administration recently announced its intention to rescind a 510 (k) clearance of a company’s medical device product after they previously granted marketing clearance for the product in 2008.  K&L Gates Partner, Suzan Onel discussed this recent rescission decision and the implications it will have for the medical device industry. 

Topics included:

  • How this decision may affect medical device companies
  • How this decision may affect investments into the medical device industry
  • Status of proposed reforms to the 510 (k) program