Monday, June 24, 2013

Industry Says Update To 510(k) Modification Policy Should Emphasize Design Controls, Risk Management

Industry Says Update To 510(k) Modification Policy Should Emphasize Design Controls, Risk Management-thegraysheet:  FDA’s current policy for determining when a modified device needs a new 510(k) works well without major changes, device industry representatives say. But they say it could be improved with more emphasis on the importance of design controls and risk management procedures to guide a company’s decision-making process.