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Compliance In Focus
Posted by John Lehmann on Tue, Nov 27, 2012

FDA’s To-Do List 2013 - PART II

As a follow-up to yesterday’s blog, here is a list of guidance documents FDA plans to fullyPart II - 2013 Guidance Documents publish, and intends to publish in the upcoming fiscal year. Remember, these lists and increased transparency efforts are in part the result of FDA negotiations with industry for the Agency to meet different quantitative and qualitative goals for the medical device industry. This is done in hopes to allow safe and effective devices to the public in a faster, more efficient method.

Without further ado…

Prioritized medical device guidance documents that FDA intends to publish in FY 2013

Final Guidance Topics

  • Refuse to Accept (RTA) Policy for 510(k) Submissions
  • Acceptance and Filing Review for Premarket Approval Applications
  • Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies
  • In Vitro Companion Diagnostic Devices
  • Design Considerations for Pivotal Clinical Investigations for Medical Devices
  • De Novo Classification Process (Evaluation of Automatic Class III Designation)
  • The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications
  • CDRH Appeals Processes
  • Medical Device Classification Product Codes
  • The Pre-Submission Program and Meetings with FDA Staff
  • Mobile Medical Applications
  • eCopy
  • Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents

Draft Guidance Topics

  • Distinguishing and Reporting Medical Device Recalls from Product Enhancements
  • Types of Communication During the Review of Medical Device Submissions
  • FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations
  • eCopy
  • Appropriate Use of Voluntary Consensus Standards in Premarket Submissions

Device guidance documents that the Agency intends to publish, as the FDA’s resources permit:

Final Guidance Topics

  • Finalizing existing draft guidance documents

Draft Guidance Topics

  • Benefit-Risk Determinations in Premarket Notifications (510(k)s)
  • Direct to Consumer (DTC) Genetic Testing: IVDs
  • Transfer of Ownership of a Premarket Notification (510(k)) - Questions and Answers
  • Custom Devices

Guidance documents withdrawn by CDRH in FY 2013

  • The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program

Is this list full of guidance topics you were hoping to see? Any areas that you are excited about? Wishing one on the second list would be a top priority? Voice your opinion below!

Photo Credit: cathredfern
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Topics: Medical Devices, 2013 To-Do List, Guidance Documents, FDA


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