Fact Sheets

Fact Sheet

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…

Fact Sheet

Regulatory Information or Regulatory Intelligence? What About ROI?

The following commentary explores the responsibilities of consultants and clients to achieve an effective partnership. A session at the 2015 RAPS’ Regulatory Convergence in Baltimore discussed the differences between regulatory information and regulatory intelligence. Which are you paying for when you hire…

Fact Sheet

Updated FDA Requirements for AED Systems

Effective on February 3, 2015 the Food and Drug Administration issued a final order requiring premarket approval applications (PMA) to be filed for automated external defibrillator (AED) systems and accessories (such as pad electrodes, batteries, and adapters). This order was prompted by…

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