Anna Longwell
Instructor Anna Longwell
Product Id 601101
Duration 60 Minutes  
Version Recorded
Original Price $300
Special Offer Price $15
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Medical Device Complaint Handling: MDR, Reports of Removals and Corrections


This presentation will step through the FDA regulations relating to post-market product problems, and give examples of how FDA currently interprets these regulations. Following this presentation, you should be able to decide whether your customer complaint requires not only investigation, but reporting to FDA, and in what format the report should be made, and to which section of the Agency.

Why Should You Attend : Many device warning letters contain the complaint that the company has failed to adequately develop and maintain their system for dealing with product problems in the field, and that their response to the 483 pointing out this deficiency was inadequate, usually because it was not accompanied by revised documents, and evidence that personnel were adequately trained on the revised system, and evidence that the revised system was in fact working effectively. One major component of the description usually found lacking is the determination of when and how to notify FDA of the problem and how the company is dealing with it.

Areas Covered in the Session

  • QSR Requirements for Complaint Handling 21 CFR 820.198
  • Medical Device Reporting 21 CFR Part 803
  • Reports of Corrections and Removals, 21 CFR Part 806
  • HCT/P that are devices
  • Combination Products
  • Electronic Products
    • When MDR, When electronic product reporting
    • Repurchase, Repairs, Replacement

Who Will Benefit:
  • QA specialist
  • Complaint Coordinator
  • Regulatory Specialist
  • QA manager
  • QA Trainer
  • All above in Medical Device companies

Speaker Profile
Anna Longwell is currently principal attorney of the Palo Alto Law firm, Longwell and Associates, which specializes in Food and Drug law. The firm has expertise in US FDA expectations, regulation and law, affecting the development and ultimate marketing of new medical products, drugs, devices and biologics. They have served the regulatory needs of large (>$2 billion/year) divisions of Fortune 500 companies, and small (4 person) biotech start-ups. Prior to establishing the firm, Ms. Longwell was VP of Regulatory affairs for Becton Dickinson, Medical a > $2 billion/annum unit of BD engaged in global manufacture and sale of medical devices, consumer products and OTC drugs. In that context, she participated as regulatory expert in many pre-acquisition due diligence teams. Prior work experience included a division of BD investigating monoclonal antibodies as therapy, and Alza Corporation during the period when they pioneered combination products. She has been a visiting lecturer in food and drug law at the University of Santa Clara school of law, a visiting lecturer in food law at the Institute of Agribusiness, University of Santa Clara School of Business, a visiting lecturer in regulatory topics at the Haas School of Business, UC Berkeley, and the UC Santa Cruz Extension (UCSC), and an instructor for the Food and Drug Law Institute (FDLI) internship program at Catholic University, Washington DC. Currently, she is co-teaching a class in US Medical Device Regulation, winter quarters at UCSC. Ms. Longwell has coauthored a book chapter titled “Due Diligence Points to Consider” in the “Expert’s Guide to Healthcare Product Due Diligence” published by FDLI.

Ms. Longwell holds a bachelor’s degree in Chemistry from San Francisco College for Women (now USF), a Master’s degree in Physical Science from Stanford University, and a JD and MBA from The University of Santa Clara School of Law and School of Business, respectively. She is a current member of the California Bar (#166040) and the US Patent bar (#50629).

Sign Up for Our Newsletter