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How to Determine if Your Product is a Medical Device
- https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device
- Is your product a Device Software Function?The FDA refers to software functions that are device functions as “device softw…What to do if your product is not a medical deviceIf your product does not meet the definition of a medical device, it may … See more
Referencing the Definition of "Device" in the Federal …
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/referencing-definition-device-federal-food-drug-and-cosmetic-act-guidance-regulatory-documents
- FDA is issuing this guidance to clarify our approach for referencing the terms “device” and “counterfeit device” in FDA documents. For many years, the definition of …
Is My Product a Medical Device? - Food and Drug …
- https://www.fda.gov/media/131268/download
- Definition of a Medical Device Section 201(h)of the Food, Drug & Cosmetic Act (FD&C Act) defines a device as: An instrument, apparatus, implement, …
FD&C Act Chapter V: Drugs and Devices | FDA - U.S.
- https://www.fda.gov/regulatory-information/federal-food-drug-and-cosmetic-act-fdc-act/fdc-act-chapter-v-drugs-and-devices
- Federal Food, Drug, and Cosmetic Act (FD&C Act) FD&C Act Chapter V: …
Federal Food, Drug, and Cosmetic Act (FD&C Act) | FDA
- https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act
- The Federal Food, Drug, and Cosmetic Act and subsequent amending statutes are codified into Title 21 Chapter 9 of the United States Code. The listing of FD&C Act …
Referencing the Definition of “Device” in the Federal …
- https://www.federalregister.gov/documents/2021/12/16/2021-27266/referencing-the-definition-of-device-in-the-federal-food-drug-and-cosmetic-act-in-guidance
- The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Referencing the Definition of `Device' in the …
eCFR :: 21 CFR Part 860 -- Medical Device Classification …
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-860
- ( 1) It is the responsibility of each manufacturer and importer of a device to assure that adequate, valid scientific evidence exists, and to furnish such evidence to the Food and …
Device Labeling | FDA - U.S. Food and Drug Administration
- https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling
- The Federal Food, Drug and Cosmetic Act (FFDCA) is the law under which the FDA takes action against regulated products. Specifically: Section 201 (k) defines …
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
- A. Statutory Definitions 1. Drug 2. Device B. Certain key provisions of the definition of device 1. “Similar or related article” in the definition of device 2. “Primary intended...
Referencing the Definition of “Device” in the Federal …
- https://www.federalregister.gov/documents/2022/11/14/2022-24707/referencing-the-definition-of-device-in-the-federal-food-drug-and-cosmetic-act-in-guidance
- The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled “Referencing the Definition of `Device' in the …
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