The Annual Registration of Device Establishment, Form FDA 2891a, has changed substantially, the FDA announced. Companies need to complete, sign and return the original two page FDA 2891a, within 30 days of receipt. By returning the form, companies will be renewing its establishment registration for the entire year of 2007. Failure to return the form will result in the establishment not having a valid FDA medical device establishment registration.
In addition, there is no detachable "coupon" on this form as there had been on previous versions, so companies must make photocopies if they wish to retain a copy. FDA will send a confirmation letter or email upon receipt of the updated form.
Access the letter at http://www.fda.gov/cdrh/registration/2007cycleletter.html (http://www.fda.gov/cdrh/registration/2007cycleletter.html).