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. Continue reading “Regulatory Roundup: FDA Reports and Guidances in August”