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Medical Device Reporting (MDR): How to Report Medical …
- https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems
- FDA Guidance: Medical Device Reporting for User Facilities (PDF Only) (PDF - 313KB) For Questions about Medical Device Reporting, including interpretation of MDR policy: Call: (301) 796-6670...
Quality and Compliance (Medical Devices) | FDA
- https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/quality-and-compliance-medical-devices
- The FDA has established Quality System Regulations (QSR) addressing device design and validation as well as good manufacturing practices. The FDA’s regulations also address …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=820.198
- (1) All complaints are processed in a uniform and timely manner; (2) Oral complaints are documented upon receipt; and (3) Complaints are evaluated to …
Standards and Conformity Assessment Program | FDA
- https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/standards-and-conformity-assessment-program
- How to Find FDA Recognized and Non-Recognized Standards Standards that have been recognized by the FDA (either wholly or in part) are maintained and are …
Medical Device Safety | FDA - U.S. Food and Drug …
- https://www.fda.gov/medical-devices/medical-device-safety
- Medical Device Safety | FDA Medical Device Safety The FDA monitors reports …
Medical Devices | FDA - U.S. Food and Drug Administration
- https://www.fda.gov/Medical-Devices
- FDA Issues Two Warning Letters to Leading Manufacturer of Endoscopes CDRH recently issued two warning letters to a leading manufacturer of endoscopes, Olympus Medical …
Recognized Consensus Standards - Food and Drug …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
- Databases This database provides the most up-to-date list of voluntary consensus standards to which FDA will accept a Declaration of Conformity. After FDA …
Complaint Files - Food and Drug Administration
- https://www.fda.gov/files/about%20fda/published/Complaint-Files---Printable-Slides.pdf
- Complaints that are also Medical Device Reports* (MDRs) must be promptly reviewed, evaluated, and investigated by designated individual(s). Maintain in a separate portion of …
Overview of Device Regulation | FDA
- https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation
- It authorizes FDA to charge a fee for medical device Premarket Notifcation 510 (k) reviews. A small business may pay a reduced fee. The application fee applies to …
CFR - Code of Federal Regulations Title 21 - Food and …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=820
- § 820.184 - Device history record. § 820.186 - Quality system record. § 820.198 - Complaint files. Subpart N - Servicing § 820.200 - Servicing. Subpart O - …
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