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Medical Device Tracking | FDA
- https://www.fda.gov/medical-devices/postmarket-requirements-devices/medical-device-tracking
- Manufacturers of a tracked device must establish a written standard operating procedure (SOP) which includes a method for tracking the device throughout distribution and a …
Medical Device Tracking | FDA
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-tracking
- This updated guidance identifies all affected devices (those tracked and those released from tracking) in table format. The table includes two fields to describe each device: (1) …
Medical Device Tracking Guidance for Industry and …
- https://www.fda.gov/media/71205/download
- Tracking methods must provide certain critical information about the location of a tracked device within a short time frame. Manufacturers will have 3 working days to provide critical...
CAPA Medical Device Tracking | FDA
- https://www.fda.gov/capa-medical-device-tracking
- The purpose of the Medical Device Tracking Regulation is to ensure that manufacturers and importers of certain medical devices can expeditiously locate and remove these devices …
eCFR :: 21 CFR Part 821 -- Medical Device Tracking …
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-821
- ( a) Any patient receiving a device subject to tracking requirements under this part may refuse to release, or refuse permission to release, the patient's name, address, telephone …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=821&showFR=1
- (b) A manufacturer of a tracked device shall keep current records in accordance with its standard operating procedure of the information identified in …
FDA Modernization Act of 1997; Guidance on Medical …
- https://www.federalregister.gov/documents/2000/01/24/00-1542/fda-modernization-act-of-1997-guidance-on-medical-device-tracking-availability
- The Food and Drug Administration (FDA) is announcing the availability of the revised guidance document entitled “Guidance on Medical Device Tracking.”. This …
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. …
Federal Register :: Medical Devices; Device Tracking
- https://www.federalregister.gov/documents/2000/04/25/00-10251/medical-devices-device-tracking
- The Food and Drug Administration (FDA) is proposing to amend the medical device tracking regulations. The scope of the regulation and certain patient …
Use of Online Tracking Technologies by HIPAA Covered …
- https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/hipaa-online-tracking/index.html
- Generally, tracking technologies developed by third parties (e.g., tracking technology vendors) send information directly to the third parties who developed such …
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