July 27, 2011
The FDA Draft Guidance entitled, “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device”, is available.

July 26, 2011
The FDA Guidance entitled, “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems”, is available.

July 26, 2011
The FDA has announced the availability of a draft report entitled, “Identifying CDER's Science and Research Needs”.

July 21, 2011
The FDA has announced the availability of the draft guidance entitled, “Mobile Medical Applications”.

Jul 21, 2011
The FDA Guidance entitled, “Class II Special Controls Guidance Document: Electrocardiograph Electrodes”, is available.

July 20, 2011
An analysis of Premarket Review Times under the 510(k) Program is available.

July 19, 2011
The Center for Drug Evaluation and Research has issued a comprehensive list of Guidance Documents.

July 15, 2011
The FDA Guidance entitled, “Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses”, is available.

July 14, 2011
The FDA has announced the availability of a draft guidance entitled, “In Vitro Companion Diagnostic Devices”.

July 12, 2011
The FDA has announced the availability of the draft guidance entitled, “Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices”.