New FDA Medical Device Guidelines for the 1st Quarter 2013

Document Center Inc. is pleased to announce that the following new FDA Guidelines released during the first 3 months of 2013 are now available:

• Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi
• Guidance for Industry and FDA Staff - Investigational Device Exemption (IDE) Guidance for Retinal Prostheses
• Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff
• Guidance for Clinical Investigators, Industry, and FDA Staff - Financial Disclosure by Clinical Investigators
• Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation - Guidance for Industry and Food and Drug Administration Staff
• Refuse to Accept Policy for 510(k)s - Guidance for Industry and Food and Drug Administration Staff
• Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) - Guidance for Industry and Food and Drug Administration Staff
• eCopy Program for Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff

Want to see more new FDA Guidance documents?  Please see my blog, New FDA Medical Guidance Documents from the 2nd Quarter of 2013.  And I've also reviewed more in my New FDA Medical Guidance Documents from the 3rd Quarter of 2013.   For the Medical UDI Database and Labeling ruling, see Compliance Dates for the new FDA UDI Ruling.

And to get the latest information for 2015:

New FDA Medical Device Guidance Documents for the 1st Quarter 2015

Document Center can assist you not only with the standards you need, but with the regulations you must meet.  Please check in with us if there is any regulatory requirement you're having trouble finding.