This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by Laura Gilmour, MS, former FDA biomedical engineer and reviewer and Founder & Principal Consultant of LG Strategies, for a packed conversation about new device approvals, FDA guidance, patient engagement, regulatory resources, and what new reviewers need to learn on the job. Laura brings experience from several sides of MedTech, including device manufacturers, the FDA, additive manufacturing, consulting, and work supporting the Veterans Health Administration.

The team starts with two new PMAs: Promega’s OncoMate® MSI Dx Analysis System, a companion diagnostic for identifying certain patients with advanced solid tumors who may be eligible for KEYTRUDA®, and MedAlliance’s SELUTION SLR™ 014 PTCA Drug-Eluting Balloon for treating coronary in-stent restenosis. They also cover several recent Breakthrough Device Designations, including the NET Device for stimulant use disorder and VitaSmart HOPE for intestinal transplantation.

Then it’s time for eSTAR. Version 7.1 is here, along with new draft guidance addressing electronic submissions for PMAs. Allison and Michael discuss some of the latest eSTAR changes and what extending the template to PMAs could mean in practice. The group also digs into new draft guidance for robotically assisted surgical devices and an upcoming two-day FDA workshop on benefit-risk considerations for robotic devices with autonomous or remote teleoperation capabilities.

Laura, Allison, and Michael also explore patient engagement and how patient-generated data can influence benefit-risk discussions. Laura shares how her work with the Veterans Health Administration has shown her that different patient populations may have very different tolerances for risk. Michael explains why incorporating patient perspectives into an FDA discussion requires more than finding one patient willing to accept that risk.

Additional topics include:

New CDRH Learn modules on biocompatibility risk assessment and Medical Device Development Tools

The Galleri® multi-cancer early detection test advisory committee meeting

GAO findings on oversight of the FDA’s third-party review program

128 new FDA hires and lessons from three former reviewers about learning what regulators have to know versus what is simply nice to know

ARPA-H’s FASTPASS program and efforts to strengthen healthcare supply chains

Additive manufacturing, bioprinting, and Laura’s upcoming trip to ASTM ICAM

Plus: a snail with a very long memory, a PCCP joke courtesy of last week’s guest, and the regulatory possibilities of a Roomba knife fight.

Links & Resources

• Promega OncoMate® MSI Dx Analysis System + Clinical Study

• MedAlliance SELUTION SLR™ 014 PTCA Drug-Eluting Balloon + Clinical Study

• FDA Grants Breakthrough Device Designation to NET Recovery's Device for Stimulant Use Disorder

• New Draft Guidance

  • Electronic Submission Template for PMA Applications

  • Robotically-Assisted Surgical Devices—Premarket Submissions

• FDA Public Workshop: Evaluating Benefit-Risk in Robotic Medical Devices with Autonomous or Remote Teleoperation Capabilities

• New CDRH Learn Modules

  • Risk Assessment Approaches for Addressing Biocompatibility Endpoints: Presentation | Slides | Transcript

  • Introduction to Medical Device Development Tools: Presentation | Slides | Transcript

• CDRH Patient Engagement Courses

• CDRH Patient Education Program Course 2 Video: Patient-Generated & Real-World Data Throughout the Medical Device Life Cycle

• Sep. 23 Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting Announcement

• U.S. Government Accountability Office (GAO): FDA Should Strengthen Policies Guiding Audits of Third-Party Review Organizations

• ARPA-H Fast Assessment of Solutions, Therapeutics, Pharmaceuticals, and Supplies (FASTPASS) Program