Prioritized medical device guidance documents that the Agency intends to publish in FY 2013 ("A-list")
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Draft Guidance Topics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 Agency’s guidance-development resources permit each in FY 2013 ("B-list")
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- Finalizing existing draft guidance documents.
Draft Guidance Topics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
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