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 Epidemiology 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.
- Direct to Consumer Advertising – Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs
- Compounding – Guidance for Entities Considering Whether to Register as Outsourcing Facilities Under § 503B of the FDCA
- Biologics – Nonproprietary Naming of Biological Products
- 510(k)s – Refuse to Accept Policy for 510(k)s
- UDI Update – GUDID: Data Submission Compliance Date of September 24, 2015
- PMAs – Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements
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.