As of Oct. 1, 2012, medical device establishments will be required to follow these new registration/listing requirements and responsibilities:
On Sept. 12, 2012, FDA released a document entitled “Frequently Asked Questions about the New Device Registration and Listing Requirements.” The purpose of the FAQs is to assist medical device establishments in understanding and complying with the new requirements and responsibilities for registration and listing.
For advice on whether your company must comply with these new requirements, and how to do so, please contact us.