Regulatory Roundup: FDA Reports and Guidances in August

Courtney A. Stevens, Esq. | Senior Attorney, Medmarc Loss Control

Recommendations for a National Medical Device Evaluation System

On August 20, the FDA released, for public comment, a report from the Medical Device Registry Task Force and the Medical Devices FDA logo.jpgEpidemiology Network. The report described the inadequacies in the existing framework for medical device evaluation, what a more effective system would look like, what devices would be particularly ripe for evaluation via such a system, and how the system could be implemented. The full report can be found here.

FDA Issued Several New Drug and Device Guidances

The Agency issued several new guidance documents in August, including the following.




FDA Report Indicates Significant Improvement in Device Approval Times

In a report released last month as part of the Agency’s renewal of the Medical Device User Fee Act (MDUFA), the FDA revealed that it has made significant progress over the last 5 years in hastening the time to market for 510(k), PMA, and IDE devices. The most substantial change was seen in IDE review times, which were reduced by almost a year to, on average, only 30 days in 2015 (in contrast to 442 days in 2011). The full report, FDA’s Role in Ensuring American Patients Have Access to Safe and Effective Medical Device Technology, can be found here.