Center for Devices and Radiological Health regulates the firms involved in manufacturing, repackaging, labelling or importing of medical devices in the United States. Below are the basic regulatory requirements that distributors must comply with in order to get an approval from FDA: Establishment Registration – 21 CFR Part 807 Medical Device Listing – 21 CFR Part 807 Premarket Notification 510(k) – 21 CFR Part 807 Subpart E Premarket Approval (PMA) – 21 CFR Part 814 Investigational Device Exemption (IDE) – 21 CFR Part 812 Quality System Regulation (QS)/Good Manufacturing Practices (GMP) – 21 CFR Part 820 Labeling – 21 CFR Part 801 Medical Device Reporting – 21 CFR Part 803.
