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The Ultimate QA/RA Cheat Sheet

By Thomas Maeder
2 Comments
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It is surprising how little many people in the medical device industry know about freely-, widely-available resources. Often, many do not know how easy it is to find the regulations and the preambles, or about the existence of Food and Drug Administration mailing lists, phone directories and databases. MedTech Intelligence presents a basic list of non-commercial regulatory reference links, most from FDA itself. Undoubtedly, we have missed some. Send us your suggestions to make this a ‘living, growing’ list.

Where do you find the information you need? Seasoned Regulatory Affairs and Quality Assurance professionals and those new to medical device regulations and procedures can appreciate a core library of bookmarked web sites that link quickly and easily to the right information. Many are unaware of Device Advice and CDRH Learn—both extraordinarily useful, readily accessible and highly reliable sources of information on all aspect of FDA regulation of devices.

Several years ago MedTech Intelligence compiled a basic list of non-commercial regulatory reference links, most from the FDA itself, which were included as a permanent resource on MedTech Intelligence. This list has been divided into seemingly meaningful categories. Some listings appear in multiple locations (e.g. MDRs under databases and reportable events) so that people can come at them from different directions. We recently updated the list and have republished it as a result.

Undoubtedly we have missed some as new resources constantly appear, while others change or expire.  Please submit your comments and recommendations to help continuously update and improve this site as a resource for you and for the industry.

Food and Drug Administration

In Vitro Diagnostics

Combination Products

Pediatric Medical Devices

  • Searchable information, guidance documents, safety information, reports on pediatric devices

Regulations, Guidances and QSR

FDA Medical Device Databases

FDA Mailing Lists

  • FDA – A list and links to all professional and consumer mailing lists pertaining to all FDA activities
  • CDRH – A list and links to available free CDRH mailing lists for regular news and updates on key topics

Premarket Submissions

  • PMAs – Searchable database of medical device premarket approvals since 1994
  • 510(k)s – Information on the 510(k) premarket notification process and a searchable database of 510(k) clearances since 1999
  • Investigational Device Exemption (IDE) – Regulations, guidances and procedures on IDEs and clinical studies Device Labeling Requirements
  • Regulations and guidance documents concerning medical device and diagnostics labeling 
  • Software – Guidance for the content of premarket submissions for software contained in medical devices
  • Recognized Consensus Standards – Database of FDA-recognized national and international standards to which manufacturers can declare conformity in premarket submissions

Medical Device Recalls, Product Safety and Reportable Events

  • Medical Device Recalls – General information about medical device corrections and removals
  • Product Recalls Guidance – The guidance includes a checklist of documentation and information that FDA utilizes to evaluate, classify, monitor and audit product recalls
  • Recalls, Market Withdrawals & Safety Alerts – Information gathered from press releases and other public notices about certain recalls of FDA-regulated products
  • MAUDE – The  Manufacturer and User Facility Device Experience database of medical device adverse event reports, housing medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as healthcare professionals, patients and consumers
  • MDR Database – Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. MDR database search is a tool to report such incidences
  • MedSun: Medical Product Safety Network – A newsletter-based website providing monthly updates on medical device issues that may affect patient safety
  • eMDRs – Guidance, technical information, tutorials, and downloadable application for the electronic submission of electronic medical device reports

Inspections and Enforcement

Electronic Records and Reporting

  • Part 11 – Guidance document on 21 CFR Part 11 pertaining to electronic records and electronic signatures
  • eMDRs – Guidance, technical information, tutorials, and downloadable application for the electronic submission of electronic medical device reports

Humanitarian Device Exemption

International

  • Global Harmonization Task Force (GHTF) – News and events, training, study group minutes and documents
  • Recognized Consensus Standards – Database of FDA recognized national and international standards to which manufacturers can declare conformity  in premarket submissions
  • Import and Export of Devices – Information on CDRH policies and procedures pertaining to the import and export of medical devices, third-party review and inspections, and international programs, agreements, and activities
  • CDRH Learn – Audiovisual industry training models on medical device regulation presented by key members of FDA/CDRH staff; course lists available in EnglishSpanish, and Chinese

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About The Author

Tom Maeder

Comments

  1. David A. Manalan

    Great job. I gave it a plus from me on LinkedIn. One nit- The Global Harmonization Task Force (GHTF) website is no longer operational. For information about medical device harmonization, please go to:
    http://www.imdrf.org
    Great find- Quality Systems Manual – A comprehensive, easily readable small entity compliance guide to the medical device quality systems. Very difficult to find it by searching.

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