Fda Medical Device Facilities In Us

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

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

FDA regulates the sale of medical device products in the U.S. and monitors the safety of all regulated medical products.

Search Registration and Listing | FDA

https://www.fda.gov/medical-devices/device-registration-and-listing/search-registration-and-listing

Releasable establishment registration and listing information under the Freedom of Information Act is available by searching the Establishment Registration and Listing …

Establishment Registration & Device Listing - Food and …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/TextSearch.cfm

Establishment Registration & Device Listing - Food and …

https://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfRL/rl.cfm?xss=1

Device Registration and Listing | FDA

https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing

For assistance with registration and listing status, please contact the CDRH Registration and Listing Help Desk at: Phone: 301-796-7400. Email: …

MAUDE - Manufacturer and User Facility Device …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters 1 (manufacturers, importers and device user facilities) and voluntary reporters …

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 …

Medical Device Manufacturers | FDA

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-technical-guides/medical-device-manufacturers

A - Medical Device Industry Initiative. 25. B - Temporary Enforcement Moratorium. 29. C - FOI and Design Controls. 31. Note: this document is reference materials for …

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

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/fda-bioresearch-monitoring-information/facilities

Facilities -. Animal Rooms. 58.43. A testing facility shall have a sufficient number of animal rooms or areas, as needed, to assure proper: Separation of species or test …