According to the FDA spokesperson, some recalled devices are not removed from the market if alternative treatments are limited and if the issue leading to the recall can be “addressed thoroughly with a correction to the device or its labelling.” Abbott’sMitraClip cardiac devicewas recalled in ...
BRIEF DEVICE DESCRIPTION ...5 2. INTENDED USE / INDICATIONS ...5 3. CONTRAINDICATIONS ...6 4. WARNINGS
Examines legal aspects of reusing medical devices outside the manufacturer's labelled indications of use. Regulation of medical devices; Labelling requirements relating to single use and reuse; Manufacturer's obligations in practice; Dir... C Hodges - 《Medical Law Review》 被引量: 2发表: 2000年...
This is a particular problem when the files themselves change as you evolve your processes and implement corrective actions. The FDA need the DHF and the DMR to show the latest, approved versions of all the documents you use to design, build and product manage your device, plus the history ...
December 30, 2023 21 CFR Part 821 Medical Device Tracking Requirements December 23, 2023 21 CFR Part 820: Quality System Regulation December 16, 2023 21 CFR Part 814: Premarket Approval (i.e. PMA) December 9, 2023 21 CFR Part 807-E: Premarket Notifications (i.e. 510K) December 2, 2023...
special labeling requirements; • mandatoryperformance standards, both international and United States; • postmarket surveillance; • FDA medical-device-specific guidance. Class II devices typically require premarket notification by submission and FDA review of a 510(k) clearance-to-market submission...
JL Webster - 《Medical Device Technology》 被引量: 2发表: 1998年 The reuse of medical devices Examines legal aspects of reusing medical devices outside the manufacturer's labelled indications of use. Regulation of medical devices; Labelling requirements relating to single use and reuse; Manufacturer...
WiFi or Bluetooth are subject to regulatory review by the NBTC. Government review requires 30 to 45 working days and US$200. This licensing is independent from any Thai FDA regulatory requirements, and can be done before, during or after medical device licensing; but must be in place prior ...
formedical device manufactureare theISO 13485“Medical devices—Quality management systems: requirements for regulatory purposes,” and the 21 CFR Parts 820 Quality Systems Regulations (USFDA). Most countries have adopted modified versions of the ISO 13485 and/or the USFDA regulations [54]. In the...
For compliance with European medical device directives, • the clinical evaluation addresses the following Essential Requirements: - Annex 1 sections 1, 2, 5 of AIMDD (for active implantable medical devices), or - Annex I sections 1, 3, 6 of MDD (for medical devices); see Appendix A7 (...