It’s All About Risk Definition For Device Recalls
Posted by Michael Jay on Wed, Feb 23, 2011
RxTrials welcomes Gretchen Bowker with Pearl IRB as a guest blogger who wrote the below post:
A recent article in The Archives of Internal Medicine entitled Medical Device Recalls and the FDA Approval Process, reviews and challenges the apparent lack of device class designation linkage to recall risk.
http://archinte.ama-assn.org/cgi/content/full/archinternmed.2011.30
Classification of a new device is based on risk and novelty. more...