Prescription Only Medical Devices

Overview of Regulatory Requirements: Medical Devices

https://www.fda.gov/training-and-continuing-education/cdrh-learn/overview-regulatory-requirements-medical-devices-transcript

FDA has classified all medical devices into either Class I, II, and III. Currently, in the Code of Federal Regulations, there are about 1700 devices that have been classified by the FDA. They...

https://www.fda.gov/medical-devices/products-and-medical-procedures/over-counter-otc-medical-devices-considerations-device-manufacturers

Over-the-Counter (OTC) Medical Devices: Considerations for Device Manufacturers Over-the-counter (OTC) medical devices are those that may be offered …

CFR - Code of Federal Regulations Title 21 - Food and …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=801.109

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Sec. 801.109 Prescription devices. A device which, …

801.109 - Prescription devices. - LII / Legal Information …

https://www.law.cornell.edu/cfr/text/21/801.109

A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the …