Reevaluation in the Cards for FDA
MD&DI Associate Editor Maria Fontanazza just returned from the Medical Device Regulatory and Compliance Conference at Harvard University. Here is her report:
As the pace of medical innovation continues to accelerate, expect some changes from CDRH in the coming months. Scott Gottlieb, deputy commissioner for medical and scientific affairs in the Office of the Commissioner at FDA, saidÂ the agencyÂ is ready to tackle regulatory, product, and communication challenges. And with the cost of healthcare increasing, FDA needs to take steps to develop a more efficient approach, said Gottlieb.
A broad initiative, complete with a guidance document, to improve CDRHâEUR(TM)s premarket evaluation process could be coming soon. The agency is reevaluating its system for premarket review and will be working harder at monitoring the performance of products after approval. FDA also wants to communicate more effectively with the broader medical community and keep patients more informed about device issues. This includes a new approach to releasing information about recalls.