CDRHNew
Date: November 7, 2013
The following new items were added to the CDRH web pages on November 6, 2013. Previous CDRH New Items can be found on the CDRHNew Page.
- Class I Medical Device Recall: Baylis Medical TorFlex Transseptal Guiding Sheath Kit
- Design Considerations for Pivotal Clinical Investigations for Medical Devices - Guidance for Industry, Clinical Investigators, Institutional Review Boards and Food and Drug Administration Staff
- Federal Register: Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2014 Proposed Guidance Development
- Meeting materials posted for November 8, 2013 Ear, Nose and Throat Devices Panel of the Medical Devices Advisory CommitteeMeeting
- Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products - Draft Guidance for Industry and Food and Drug Administration Staff
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