The US Food and Drug Administration (FDA) regulates medical devices in the United States.
Medical Device Definition
A medical device in the United States is any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or another similar or related article, including a component part or accessory which is:
It does not achieve its primary intended purposes through chemical action within or on the body of man or other animals. Therefore, it is not dependent upon being metabolized to achieve its primary intended purposes.
- Recognized in the official National Formulary, the United States Pharmacopoeia, or any supplement to them
- Intended for use in the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, in man or other animals
- Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals
Medical Device Classification System
||Tongue depressors, bandages, and hand-held surgical instruments
||Wheelchairs, pregnancy test kits, and certain types of pacemakers
||Implantable pacemakers, breast implants, and heart valves
||Class I:- 1 Month, Class II:- 4-8 Months, Class III:- 18-30 Months
|License validity period
||Device registration: unlimited as long as there are no substantial changes to the device.
510(K) :- $19,870 (For small business:- $4967)
PMA :- $441,547 (For small business :- $110,387)
De novo classification request :- $132,464 (For small business :- $33,116)