FDA issues final rule for 3 Class III devices

08/18/2011 | MedCityNews.com

The FDA released a final rule requiring makers of three Class III devices that were once considered for 510(k) review to submit premarket approval applications to the agency. Makers of ventricular bypass devices, female condoms and pacemaker repair and replacement material must file a PMA with the agency within 90 days of Tuesday, according to the rule.

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