Charles Tritt

FDA CDRH Priority List

Posted by Charles Tritt Dec 5, 2013

The Center for Devices and Radiologic Health (CDRH) is the part of the FDA that deals with medical device regulations. As part of a new law, they will now annually publish a list of their priorities for the coming year. The complete  2014 list can be found at:

CDRH Fiscal Year 2014 (FY 2014) Proposed Guidance Development

Biomedical engineers should be aware of the items on this. Here are some highlights that I noticed:

Final Guidance Topics

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

The Pre-Submission Program and Meetings with FDA Staff

The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications

Types of Communication During the Review of Medical Device Submissions

Applying Human Factors and Usability Engineering to Optimize Medical Device Design

Global Unique Device Identification Database

Design Considerations for Pivotal Clinical Investigations for Medical Devices

Draft Guidance Topics

Benefit-Risk Determinations in Premarket Notifications (510(k)s)

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions

Custom Devices

Hearing Aids and Personal Sound Amplification Products (PSAPs)

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