guidance Archives - Boston Biomedical Associates

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CDRH Modular PMA Alert – Process Changes

The FDA’s Center for Device and Radiological Health (CDRH) has issued a memo to modular PMA Holders regarding the implementation of PMA process changes that went into effect on June 13, 2016. The memo addresses how incoming Modular PMA submissions will be…

Final FDA Guidance – Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act

The FDA Issued a final guidance on May 16, 2016 intended to provide assistance and clarification to manufacturers of devices subject to FDA postmarket surveillance orders. These orders are issued at the time of device approval or clearance or any time thereafter….

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Fact Sheet

CDRH Modular PMA Alert – Process Changes

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Final FDA Guidance – Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act

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