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New and Noteworthy

  • The Food and Drug Administration (FDA) is proposing to reclassify ultraviolet (UV) lamps intended to tan the skin from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and to rename them sunlamp products. FDA is also designating special controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the device. FDA is proposing this reclassification on its own initiative based on new information. [Proposed Order]
  • 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 interesting 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  • FDA CDRH issues a new draft guidance: “Refuse to Accept Policy for 510(k)s” [PDF]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  • FDA CDRH issues a new draft guidance, “Acceptance and Filing Review for Premarket Approval Applications (PMAs),” on July 31, 2012, for comment purposes [PDF] [Comment]
  • FDA issues a “Draft Guidance for Industry and FDA Staff Medical Devices on The Pre-Submission Program and Meetings with FDA Staff” [Guidance] [Comment]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]
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