Regulations For Medical Implants

Implants and Prosthetics | FDA

https://www.fda.gov/medical-devices/products-and-medical-procedures/implants-and-prosthetics

The risks of medical implants include surgical risks during placement or removal, infection, and implant failure. Some people also have reactions to the materials used in implants. All surgical ...

Medical Device Standards and Implant Standards

https://www.astm.org/products-services/standards-and-publications/standards/medical-device-standards-and-implant-standards.html

ASTM's medical device and implant standards are instrumental in specifying and evaluating the design and performance requirements of a number of biomedical …

Dental Implants: What You Should Know | FDA

https://www.fda.gov/medical-devices/dental-devices/dental-implants-what-you-should-know

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=812.3

(a) Act means the Federal Food, Drug, and Cosmetic Act (sections 201-901, 52 Stat. 1040 et seq., as amended (21 U.S.C. 301-392)). (b) A custom device means a …

Safety of Metals and Other Materials Used in Medical …

https://www.fda.gov/medical-devices/products-and-medical-procedures/safety-metals-and-other-materials-used-medical-devices

The FDA accepted feedback through August 18, 2021 in a public docket FDA-2021-N-0334 . Numerous types of materials, including metals, polymers and …

Overview of Device Regulation | FDA

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

Device Advice. Overview of regulations for medical devices: premarket notifications (510(k)), establishment registration, device listing, quality systems, labeling …

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=860.3

The information on this page is current as of Jan 17, 2023. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations …

Tissue Implants - Traceability of Records - Joint …

https://www.jointcommission.org/standards/standard-faqs/ambulatory/transplant-safety-ts/000001800/

Alternatively, the patient's physician might notify the infection control nurse of a post-op infection associated with the tissue implant. Procedures and records should …

Medical Device Regulation: Requirements for Dental

https://pubmed.ncbi.nlm.nih.gov/33722134/

A custom-made device (CMD) is a medical device intended for the sole use of a particular patient. In a dental setting, CMDs include prosthodontic devices, orthodontic appliances, …

Medical Regulations and Guidance Resource Links

https://www.fmcsa.dot.gov/regulations/medical/medical-regulations-and-guidance-resource-links

Provides requirements for medical examiners to maintain their certification and listing on the National Registry. Reasons for removal from the National Registry of Certified …