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General Controls for Medical Devices | FDA
- https://www.fda.gov/medical-devices/regulatory-controls/general-controls-medical-devices
- Medical devices are subject to the adulteration provisions of the FD&C Act under Section 501. The first two provisions of Section 501 define adulteration for most cases. A device is held to be adulterated if it includes any filthy, putrid, or decomposed substance, or if it is prepared, packed, or held … See more
21 U.S. Code § 351 - Adulterated drugs and devices
- https://www.law.cornell.edu/uscode/text/21/351
- A drug or device shall be deemed to be adulterated—. (a) Poisonous, insanitary, etc., ingredients; adequate controls in manufacture. (1) If it consists in whole or in part of any …
Regulatory Controls | FDA - U.S. Food and Drug …
- https://www.fda.gov/medical-devices/overview-device-regulation/regulatory-controls
- Federal law (Federal Food, Drug, and Cosmetic Act, section 513), established the risk-based device classification system for medical devices. Each device is assigned to one …
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 …
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 …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=225.1
- (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act provides that a drug (including a drug contained in a medicated feed) shall be …
Misbranded & Adulterated Medical Devices - FDA …
- https://blog.clevercompliance.io/medical-product-compliance/misbranded-adulterated-medical-devices/
- An adulterated medical device is any product that has been corrupted or debased by incorporating an impure or spurious substance. The FDCA has …
Introduction to Medical Device Recalls
- https://www.fda.gov/media/78333/download
- Adulterated – includes but is not limited to a device that does not meet the performance standard established under section 514 of the FD&C Act; a device that is not in …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=110&showFR=1
- (a) The criteria and definitions in this part shall apply in determining whether a food is adulterated (1) within the meaning of section 402(a)(3) of the act in that the …
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
- The FDA refers to software functions that are device functions as “device software functions.” Device software functions may include “Software as a Medical …
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