The Ultimate QA/RA Cheat Sheet

By Thomas Maeder
October 13, 2017


• Categories: 04-Product Design & Development, 05-Quality/Regulatory, RC - Medtech Regulatory Resource Center

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

• FDA Home Page – Official homepage for the Food and Drug Administration
• FDA History
• Health and Human Services Employee Directory – Searchable directory with contact information of all HHS employees
• Office of Regulatory Affairs Directory – Headquarters and field directory by region and districts for the Office of Regulatory Affairs, charged with inspections, compliance, enforcement, and criminal investigations
• Food, Drug & Cosmetic Act – Laws and amendments giving the U.S. Food and Drug Administration regulatory authority over food, drugs, cosmetics, medical devices, biologics, animal drugs and feed, radiation-emitting products, and tobacco
• Code of Federal Regulations – Complete searchable text of CFR Title 21 pertaining to food, drugs, and medical devices
• Food and Drug Administration Modernization Act (FDAMA) of 1997  – Information, links about the FD&C act amendment- FDAMA 1997
• Food and Drug Administration Amendments Act (FDAAA) of 2007 – Information, links about the FD&C act amendment- FDAAA 2007
• Center for Devices and Radiological Health (CDRH) Home Page – Link to information related to medical devices and radiation emitting products that come under FDA jurisdiction under the Center for Devices and
  Radiological Health (CDRH)
• The CDRH Organization Directory – Includes contact information about the different sections of the CDRH.
• CDRH Mailing Addresses and Office Phone Numbers  – Includes mailing addresses and phone numbers of the offices coming under CDRH.
• CDRH Referral List – Who to contact with questions on specific, alphabetically listed, device and diagnostics issues
• Conflict Resolution – An advisory panel to resolve conflicts between the FDA and the medical device
  sponsors, manufacturers, applicants regulatory decisions and actions by FDA and so on.
• Medical Device Advisory Committee – Information, links, and contact information for the 18 advisory committee panels
• Medical Device User Fee and Modernization Act (MDUFMA) – Information, links and contact information for the 18 advisory committee panels
• MDUFMA Performance Reports 2003 – 2016 – User fee performance reports for each year from 2003-2016
• History of CDRH – Article from the centennial edition of FDA Consumer magazine on the history of medical device regulation
• Device Advice – Information for regulated industry on determining how to comply with the federal laws and regulations governing medical devices. A rich source of information and links to comprehensive pre- and post-market information on medical devices and diagnostics
• CDRH Learn – Audiovisual industry training models on medical device regulation presented by key members of FDA/CDRH staff; course lists available in English, Spanish, and Chinese
• CDRH Mailing Lists – A list and links to available free CDRH mailing lists for regular news and updates on key topics
• CDRH Guidance documents – Includes all guidance documents related to FDA regulated medical devices and radiation emitting products
• 510(k) submission process – Explanation of 510(k) process, with timeline of communication

In Vitro Diagnostics

• Office of In Vitro Diagnostics– Links to news and events, regulatory resources, and searchable IVD and CLIA databases

Combination Products

• Office of Combination Products – Website, with links to procedures, guidance documents, reports, and other resources

Pediatric Medical Devices

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

Regulations, Guidances and QSR

• Food, Drug & Cosmetic Act – Laws and amendments giving the U.S. Food and Drug Administration regulatory authority over food, drugs, cosmetics, medical devices, biologics, animal drugs and feed, radiation-emitting products, and tobacco
• Code of Federal Regulations – Complete searchable text of CFR Title 21 pertaining to food, drugs, and medical devices
• Food and Drug Administration Modernization Act (FDAMA) of 1997– Searchable information and links about the FD&C act amendment- FDAMA 1997
• Food and Drug Administration Amendments Act (FDAAA) of 2007 – Searchable information and links about the FD&C act amendment- FDAAA 2007
• Medical Device User Fee and Modernization Act (MDUFMA) – Information, links, and contact information for the 18 advisory committee panels
• MDUFMA Performance Reports 2003 – 2016 – User fee performance reports for every year from 2003-2016
• Quality System Regulation – 21 CFR Parts 808, 812, and 820 specifically related to medical device cGMPs and the Quality System Regulation, including the preamble
• Quality Systems Manual – A comprehensive, easily readable small entity compliance guide to the medical device quality systems
• Design Control Guidance – 21 CFR part 820, Revised CGMP by including them into the QSR, to assure that good quality assurance practices are used worldwide to design medical devices
• Human Factors – Information and resources from CDRH on the application of human factors engineering to medical devices
• Applying Human Factors and Usability Engineering to Medical Devices – Guidance document on incorporating human factors engineering into risk management to improve medical device use safety
• Device Labeling Requirements – Regulations and guidance documents concerning medical device and diagnostics labeling
• Part 11 – Guidance document on 21 CFR Part 11 pertaining to electronic records and electronic signatures

FDA Medical Device Databases

• Product Code Classification Database – Searchable CDRH database of device names and associated product codes, including information on how to classify a device and on devices regulated by other Centers
• Medical Device Establishment Registration and Device Listing – This database includes device
  manufacturers registered with FDA and devices listed with FDA
• 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
• Databases related to recalls and adverse events under “Medical Device Recalls, Product Safety and Reportable Events”
• Downloading Listing information from FURLS/Device Registration and Listing Module – Provides instructions for a firm’s owner, operator or official correspondent of a registered establishment to download listing information from the FURLS DLRM

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
  • Medical Device Recalls Database – Database of medical device recalls since 2002
  • Recalls, Corrections and Removals – Includes information about the recalls, corrections and
    removals of the devices and relevant definitions
  • Urgent Device Recall – Downloadable Word document required for the urgent device recall
• 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

• Regulatory Procedures Manual – A reference manual for FDA personnel providing information on internal procedures used in domestic and import regulatory and enforcement matters
• Investigations Operations Manual – The FDA’s guidance document on policies and procedures for field investigators conducting inspections
• Guide to Inspections of Medical Device Manufacturers – The FDA’s guidance document on when to do a directed inspection, the definitions of comprehensive and directed inspections, and other device specific policy requirements
• Quality System Inspection Technique Manual – The FDA field staff guidance to inspection of medical device facilities using the QSIT
• Enforcement Reports – Complete searchable database of FDA Enforcement Reports from 2004 to the present, with a link to sign up for weekly e-mailed updates
• FDA Warning Letters – Searchable database of FDA warning letters from 1996 to the present
• Medical Device Recalls – Database of medical device recalls since 2002

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

• Regulations, procedures, and approvals

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 English, Spanish, and Chinese

Trade Associations

• AMDM (Association of Medical Diagnostics manufacturers) – AMDM is a nonprofit trade association that serves as an educational resource for regulatory submissions and other compliance information related to the in vitro diagnostic industry
• MDMA (Medical Device Manufacturers Association) – MDMA is a national trade association based in Washington, D.C. providing educational and advocacy assistance to innovative and entrepreneurial medical technology companies
• AdvaMed – AdvaMed is a trade association that leads the effort to advance medical technology in order to achieve  healthier lives and healthier economies around the world

Academia

• FDA Learning Portal for Students, Academia and Industry – Provides education and resources related to FDA’s regulatory, product quality and safety responsibilities

Feel free to send us your suggestions to make this a living, growing list.

Northeastern graduate students Tejasri Parchuri, Aayushi Kasilwai, Kruti Damani and Yi Zhang contributed to an updated version of this guide.