Report from MD&M West Conference: Navigating through the PMA and 510(K) Submission Processes

I recently had the opportunity to chair a track and present a session on FDA and a Global Regulation in Practice at the MD&M West Conference. The conference was held at the Anaheim a Convention Center from Monday, February 10th through Thursday February 13th, 2014. Below is a summary of the proceedings for Day 2: NAVIGATING THROUGH THE PMA AND 510(K) SUBMISSION PROCESSES.

The track started with a presentation from FDA's Marjorie Shulman, Director, Premarket Notification (510(k)) Section, CDRH. Her case study-based presentation on uncovering the blind spots in 510(k) submissions was well-received, as industry always appreciates candid opportunities to hear and discuss with FDA on submission related matters.

Marjorie covered items in her presentation that were topical and relevant:
  • What an outside expert may see when a draft 510(k) is presented for review before a submission;
  • Common mistakes seen in drafting a 510(k);
  • Understanding the 510(k) as an advocacy document, not just a data transmission, and
  • Beginning with the end in mind in of regulatory strategy and claims submission.
Marjorie fielded questions from the audience related to the 510(k) submission process and FDA's review. She spent particular time on FDA holds and how MDUFMA time milestones are calculated. Hint: hold times are not counted.

The next speaker was Mark DuVal, President, DuVal & Associates. Mark presented on deciding when to submit a new 510(k) for a modified device and whether a new regulatory approach is needed. This lively presentation covered areas of:
  • Understanding the FDAs current 510(k) modifications document and its standard;
  • Knowing FDAs current thinking reflected by the 510(k) modifications guidance, which was forcibly withdrawn under FDASIA;
  • Understanding how FDA becomes aware of potential modifications, and
  • How to deal with FDA in those situations.
Mark answered audience questions regarding modifications and implications of not notifying FDA as well as when it is appropriate.

Mark was followed by Donald J. Sherratt, Director Regulatory Affairs and Compliance, QRA Management, Respiratory Ventilation, CareFusion. Donald's presentation centered on his frustrations of inconsistencies within FDA for Class III product updates. Particularly, about a Class III device that simply required a 30-day notice but was then told after 90 days that a PMA Supplement would be required. Highlights of his presentation:
  • CareFusion filing a 30-day notice for a change in the manufacturer of a stopcock for a water trap on a ventilator
  •  90 days later FDA responded to the notice and asked for a 135-day Supplement because, in their opinion, the change of the stopcock presents a risk to the patient;
  • He filed the supplement, and
  • FDA replied that this would now be a 30-day supplement.
Donalds somewhat humorous and ironic presentation made light of a frustrating problem. Unfortunately, no one in the audience had an answer that satisfied his requirements. In other words, the frustrations continue.

Michael Drues, Ph.D., President of Vascular Sciences presented on an interesting strategy for keeping competitors at bay, which essentially embraced the PMA pathway to differentiate a product from its competitors. This leaves a significantly high bar for others to get over and can keep casual “me too” devices off the market. Of course, the downsides of a PMA have to be weighed:
  • Pre-Market Approval
  • Clinical data
  • Longer approval times
  • Higher costs and burn rates
The audience had several questions regarding practical examples of this strategy and whether it has been successful in the real world. 
Mark DuVal, President, DuVal & Associates took the stage again (as a last minute replacement speaker) and spoke of the PMA pathway to approval. His session was highlighted with the following topics:
  • Predicate Device (or lack thereof)
  • De Novo
  • Class III designation
  • Clinical Submission
The audience was a little fatigued and no questions were asked.
Finally, I had the opportunity to present on the PMA pathway and how it is not a cookie-cutter approach. I highlighted the areas where the sponsor must take use a customized, hand-on process to complete the PMA submission:
  • Risk Analysis 
  • De Novo down-classification (Class III to Class II)
  • IDE Process (IRB, etc.)
  • Clinical (endpoints, trial design, etc.)
  • Dossier Submission
Questions asked after the presentation focused on the De Novo down-classification, which is an underused process that can make a big difference in approval times. 
All-in-all it was a very informative conference and well attended. Very good, probing questions were asked, indicating a high level of engagement from participants.
Did you attend MD&M West?  If you did, what did you learn that was new to you? Would you attend again next year?

By Peter Knauer, Senior QCC Consultant, MasterControl Inc.
Peter Knauer is a partner consultant with MasterControl's Quality and Compliance Advisory Services. He has more than 20 years of international experience in the biomedical industry, primarily focusing on supply chain management, risk management, CAPA, audits and compliance issues related to biopharmaceutical and medical device chemistry, manufacturing and controls (CMC) operations. He was most recently head of CMC operations for British Technology Group in the United Kingdom and he has held leadership positions for Protherics UK Limited and MacroMed. Peter started his career at Genentech, where he held numerous positions in engineering and manufacturing management. Peter is currently chief operating office for BioUtah and a member of the Parenteral Drug Association (PDA). Peter holds a master's degree in biomechanical engineering from San Francisco State University and a bachelor's degree in materials science engineering from the University of Utah. Contact him at

Note: The views expressed in this article are those of the author and do not necessarily represent those of his or her employer, GxP Lifeline, its editor or MasterControl Inc.