Establishment Registration And Medical Device Listing

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: …

Search Registration and Listing | FDA

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

Establishment Registration and Medical Device Listing Files for Download ; Releasable establishment registration and listing information under the Freedom of Information Act is available by ...

Establishment Registration & Device Listing - Food and …

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

Establishment Registration and Medical Device Listing …

https://www.fda.gov/medical-devices/device-registration-and-listing/establishment-registration-and-medical-device-listing-files-download

ESTABLISHMENT. TYPE ID. ESTABLISHMENT DESCRIPTION. 1. Manufacture Medical Device for Another Party (Contract Manufacturer) 2. Sterilize …

How to Register and List | FDA

https://www.fda.gov/medical-devices/device-registration-and-listing/how-register-and-list

The registration of a medical device establishment is a two-step process. First you must pay the annual registration user fee. ... Identify the manufacturer by using either its …

Establishment Registration & Device Listing - Food and …

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

Databases. This database includes: medical device manufacturers registered with FDA and. medical devices listed with FDA. Note: Registration of a …

When to Register and List | FDA

https://www.fda.gov/medical-devices/device-registration-and-listing/when-register-and-list

Initial Registration. Submit registration and /or listing information within 30 days of an establishment beginning an activity or putting a device into commercial distribution.

eCFR :: 21 CFR Part 807 -- Establishment Registration and Device ...

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-807

(a) Any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a device that is imported or offered for import into the United States shall register such establishment and list such devices using the FDA electronic device registration and listing system in conformance with ...

Who Must Register, List and Pay the Fee | FDA

https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee

Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States (U.S.) are required to register annually with the FDA.

Establishment Registration & Device Listing

https://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfRL/rl.cfm?lid=800899&lpcd=FGX

Establishment Registration & Device Listing. FDA Home; Medical Devices; Databases - New Search: Back To Search Results: Classification Name: SNARE, NON …