US FDA calls for updated product safety data:
This article was originally published in Clinica
Executive Summary
The FDA has asked for updated safety data on certain products to help it reach decisions on reclassification. The request applies to Class III devices in 15 product areas which were on the market prior to 1976. The agency intends to review whether these should be reclassified as Class II or I devices or be subject to a PMA review. The FDA said manufacturers need to submit their 515(i) information by August 14th and recommended that companies making similar products collaborate on a single document for submission.