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New and Noteworth
- FDA issues proposal to improve the quality of automated external defibrillators. The proposed order, if finalized, will require manufacturers of these life-saving devices to submit pre-market approval (PMA) applications. [Press Announcement]
- FDA announces public-private partnership to develop regulatory science that will speed patient access to new medical device technologies [Press Announcement]
- FDA posts a letter to industry announcing the launch of the CDRH Export Certification and Tracking System (CECATS) [FAQ]
- The Society of Clinical Research Associates (SoCRA) is pleased to announce an FDA Clinical Trial Requirements Regulations, Compliance, and Good Clinical Practice Conference in co-sponsorship with the FDA Dallas District Office on March 6 through 7, 2013 [More Information]
- FDA posted an intersting video on Regulatory Science
- Did you know that you can now submit online a request for information to the FDA under the Freedom of Information Act (FOIA)?
- FDA CDRH Letter to Industry: “Medical Device Establishment Registration and Listing – Notice of Changes for FY 2013″ [HTML]
- FDA CDRH issues a new draft guidance: “Refuse to Accept Policy for 510(k)s” [PDF]
- FDA issues a new guidance on FY 2013 Medical Device User Fee Small Business Qualification and Certification [PDF]
- FDA CDRH issues a new draft guidance, “Acceptance and Filing Review for Premarket Approval Applications (PMAs),” on July 31, 2012, for comment purposes [PDF] [Comment]
- FDA issues a “Draft Guidance for Industry and FDA Staff Medical Devices on The Pre-Submission Program and Meetings with FDA Staff” [Guidance] [Comment]
- FDA proposes unique device identification system for medical devices [Press Release]
- FDA publishes new guidance on considerations used in device approval, de novo decisions [Press Release] [Guidance]
- How FDA’s Science and Engineering Labs Solve Public Health Problems: The Huber Needle Story [Video]
- Networking, Social Media, and staying informed:
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