Guidance on Non-Clinical Testing for Intravascular Stents
08/30/2013
Federal Register Notice: FDA is making available a draft guidance entitled Select Updates for Non-Clinical Engineering Tests and R...
Info on Submitting Info to CVM with e-Submission Gateway
08/30/2013
Federal Register Notice: FDA’s proposed collection of information, “Guidance for Industry 108 on How To Submit Informa...
Guidance on Certification for Medical Gases
12/18/2012
Federal Register Notice: FDA is making available a draft guidance for industry, Certification Process for Designated Medical Gases...
Guidance on Enrichment Strategies in Trials for NDAs, BLAs
12/17/2012
Comments Sought on HDE Applications
12/17/2012
Federal Register Notice: FDA is seeking public comment on information to accompany humanitarian device exemption applications and ...
Guide on RFID Studies is Extended
12/17/2012
Info on Tobacco Industry Meeting Guidance Sent to OMB
12/13/2012
Guidance Out on Design Considerations for Home Use Devices
12/13/2012
Guidance on Product Design Safety Considerations
12/13/2012
Device Product Name Corrected
12/13/2012
