Medical Devices For US Market
The Center for Devices and Radiological Health (CDRH) of US FDA is responsible for regulating firms who manufacture, repackage, re-label, and/or import medical devices sold in the United States. The Federal Food, Drug, and Cosmetics Act (FD&C Act), Title 21 Code of Federal Regulations 21 (CFR) Parts 800 to 1299 are the regulations for governing the medical devices in the States.
Below please find some key regulations for general or special controls of medical devices for your reference: Establishment Registration - 21 CFR Part 807 Medical Device Listing - 21CFR Part 807 Pre-market Notification 510(k) - 21 CFR Part 807 Subpart E Pre-market Approval (PMA) - 21 CFR Part 814 Quality System Regulation (QS)/Good Manufacturing Practices (GMP) - 21 CFR Part 820 (QS) / (GMP) – 21 CFR 820 Labeling - 21 CFR Part 801 Medical Device Reporting - 21 CFR Part 803 Post-market Surveillance - 21 CFR Part 822 Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Pre-market Notification 510(k); most Class II devices require Pre-market Notification 510(k); and most Class III devices require Pre-market Approval.
ClassControlProduct ExampleClass I
General ControlsBand Aids
Patient Examination Glove
General ControlsSpecial Controls (e.g. 510(k)) Surgical Mask
Hypodermic Single Lumen Needle
General ControlsSpecial ControlsPre-market Approval (PMA)
Implantable Pacemaker Pulse Generator
Implanted Neuromuscular Stimulator
We offer testing services on medical devices. Should you have the needs, please contact us now!
Man Mak (Life Science)
t: + 852 2609 9611 (ext 3353)
f: + 852 2603 7577
Man Chan (Hardlines)
t: + 852 2774 7168
f: + 852 2646 0026
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