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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 quality assurance...
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=820&showFR=1&subpartNode=21:8.0.1.1.12.12
- (b) Each manufacturer shall maintain distribution records which include or refer to the location of: (1) The name and address of the initial consignee; (2) The …
eCFR :: 21 CFR Part 821 -- Medical Device Tracking …
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-821
- ( 1) A multiple distributor shall keep written records of the following each time such device is distributed for use by a patient: ( i) The unique device identifier (UDI), lot number, batch …
eCFR :: 21 CFR 820.160 -- Distribution.
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-L/section-820.160
- § 820.160 Distribution. ( a) Each manufacturer shall establish and maintain procedures for control and distribution of finished devices to ensure that only those devices approved …
Medical Device Tracking—How It Is and How It Should Be
- https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2774431
- Electronic Health Records Emergency Medicine End of Life Environmental Health Equity, Diversity, and Inclusion Ethics Facial Plastic Surgery Gastroenterology and …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=211&showFR=1&subpartNode=21:4.0.1.1.11.10
- (b) Records shall be maintained for all components, drug product containers, closures, and labeling for at least 1 year after the expiration date or, in …
Distribution records | Therapeutic Goods Administration …
- https://www.tga.gov.au/distribution-records
- Under section 41FO of the Therapeutic Goods Act 1989 sponsors of medical devices supplied in, and exported from, Australia are required to keep distribution records …
MEDICAL DEVICE GUIDANCE DOCUMENT …
- https://cmsmedtech.com/wp-content/uploads/2020/07/Distribution-Records_60.60_3june2020-1-1.pdf
- The distribution record shall contain sufficient information to permit complete and rapid withdrawal of the medical device from the market, where …
MDR - Distributor Requirements (that also …
- https://www.johner-institute.com/articles/regulatory-affairs/and-more/distributor-requirements/
- 1. What a “distributor” is (and what it isn't) a) Definition The Medical Device Regulations (MDR) has many roles, under which the economic operators are listed. …
Storage and Distribution Controls of …
- https://emmainternational.com/storage_and_distribution_controls_of_medical_devices/
- These practices generally address requisition of parts, usage records, return of unused stock and required authorizations to minimize the possibility of unauthorized …
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