The QA/ RA Cheat Sheet

By Thomas Maeder
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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. 

MedTech  Intelligence has compiled a basic list of non-commercial regulatory reference links, most from Food and Drug Administration itself, which will be included as a permanent resource on the home page. 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.

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

Regulations, Guidances and QSR

FDA Medical Device Databases

In Vitro Diagnostics

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   
  • 510(k) process evaluation – Internal assessments and working group reports on the 510(k) premarket review process and the use of science in regulatory decision making by CDRH (documents last updated in September 2010)  
  • 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

Product Safety and Reportable Events

  • MAUDE – The FDA Manufacturer and User Facility Device Experience database of medical device adverse event reports
  • MDR Database – Searchable MDR database
  • 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
  • Medical Device Recalls – Database of medical device recalls since 2002

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

Combination Products

Humanitarian Device Exemption

Pediatric Devices

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

Again, do send us your suggestions to make this a ‘living, growing’ list. 

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