Keeping in Compliance

The majority of domestic laboratories do not have to register with the FDA. Only those who fabricate appliances meant to treat sleep apnea and snoring, considered anesthesia devices, must complete a medical listing form with the FDA. Laboratories that are initial importers for foreign laboratories must register as well. Here is background information and many of the forms you will need to keep in compliance with FDA regulations as a medical device manufacturer or importer. 

Establishment Registration Background
U.S. Agents for Devices Background

Initial Registration Form

Medical Device Listing Background
Medical Device Listing Form

Author Information