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Medical Device Tracking | FDA
- https://www.fda.gov/medical-devices/postmarket-requirements-devices/medical-device-tracking
- Medical Device Tracking | FDA Medical Device Tracking Manufacturers are required to track certain devices from their manufacture through the distribution chain when they …
Medical Device Tracking | FDA
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-tracking
- FDA is issuing this guidance to announce that both the list of devices subject to medical device tracking requirements, and the list of medical devices released from tracking...
Medical Device Tracking Guidance for Industry and …
- https://www.fda.gov/media/71205/download
- The Food and Drug Administration (FDA) is issuing this guidance to announce that both the list of devices subject to medical device tracking requirements, and the list of medical...
CAPA Medical Device Tracking | FDA
- https://www.fda.gov/capa-medical-device-tracking
- Verify that the firm is aware of its obligation to: (1) notify FDA if it goes out of business and provide copies of its tracking records to its FDA District Office; (2) transfer tracking...
Guidance Documents (Medical Devices and Radiation …
- https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products
- Guidance documents are documents prepared for FDA staff, regulated industry, and the public that describe the agency's interpretation of or policy on a regulatory issue. …
eCFR :: 21 CFR Part 821 -- Medical Device Tracking …
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-821
- § 821.25 Device tracking system and content requirements: manufacturer requirements. ( a) A manufacturer of a tracked device shall adopt a method of tracking for each such …
Search for FDA Guidance Documents | FDA - U.S. Food …
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents
- The table below lists all official FDA Guidance Documents and other regulatory guidance. You can search for documents using key words, and you can narrow or filter your results …
Send and Track Medical Device Premarket Submissions …
- https://www.fda.gov/medical-devices/industry-medical-devices/send-and-track-medical-device-premarket-submissions-online-cdrh-portal
- The FDA will maintain and improve on the Customer Collaboration Portal as described in the Draft: Medical Device User Fee Amendments (MDUFA) Performance …
Devices Guidances | FDA - U.S. Food and Drug …
- https://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/devices-guidances
- FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions; …
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