FDA recently issued draft guidance, entitled “Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements.” The guidance was issued to clarify when a change in a medical device product warrants a recall. Additionally, the guidance distinguishes and defines a product enhancement from a product recall. FDA is accepting comments until May 23, 2013. To read the full draft guidance, click here. To read a related article, click here. Need help with a medical device submission? Please contact us at 317-899-9341 to help with your submissions.
