Federal Drug Administration Medical Devices

Medical Devices | FDA - U.S. Food and Drug Administration

https://www.fda.gov/Medical-Devices

Approvals and clearances, information on medical devices by type Digital Health Center of Excellence Cybersecurity, mobile medical apps, wireless medical devices, AI/ML in Software as a...

U.S. Food and Drug Administration

https://www.fda.gov/

Drugs More Recalls Market Withdrawals & Safety Alerts Subscribe to the Enforcement Report Mailing List FDA VOICES: PERSPECTIVES FROM FDA EXPERTS FDA …

Overview of Device Regulation | FDA - U.S. Food and …

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave …

How to Determine if Your Product is a Medical Device | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device

FD&C Act Chapter V: Drugs and Devices | FDA

https://www.fda.gov/regulatory-information/federal-food-drug-and-cosmetic-act-fdc-act/fdc-act-chapter-v-drugs-and-devices

FD&C Act Chapter V: Drugs and Devices | FDA An official website of the United States government Here’s how you know U.S. Food and Drug Administration Search …

Classification of Products as Drugs and Devices and …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/classification-products-drugs-and-devices-and-additional-product-classification-issues

FDA’s determination of whether to classify a product as a drug or device is based on statutory definitions, as set forth in sections 201(g) and 201(h) of the FD&C Act, …

Contact FDA | FDA - U.S. Food and Drug Administration

https://www.fda.gov/about-fda/contact-fda

To report an emergency involving food, drugs, medical devices, dietary supplements, or cosmetics, call 1-866-300-4374 or 1-301-796-8240. Report a problem …

Federal Register :: Medical Devices; Ear, Nose, and …

https://www.federalregister.gov/documents/2022/08/17/2022-17230/medical-devices-ear-nose-and-throat-devices-establishing-over-the-counter-hearing-aids

Under § 801.109(a), a prescription device is a device that is: (1) either in the possession of a person, or his agents or employees, regularly and lawfully engaged in the …

Federal Register :: Medical Devices; Hematology and …

https://www.federalregister.gov/documents/2023/02/02/2023-02141/medical-devices-hematology-and-pathology-devices-classification-of-the-software-algorithm-device-to

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is classifying the software algorithm device to assist users in digital pathology into class II …