Join us September 21-23 in Bethesda, Maryland for the 2026 OSMA Fall Meeting hosted at both the Hyatt Regency Hotel in downtown Bethesda and the FDA White Oak Campus!
Accommodations:
The Hyatt Regency is located in downtown Bethesda. Please login to view accommodation information.
Agenda
Monday, September 21 | Hyatt Regency Rooftop Room
12:00PM | Lunch
1:00-5:00PM | Educations Sessions
- OSMA and OAR Updates | Ryan Belaney, Phoenix Kinetics; Lisa Boyle, Exalta; Valerie Giambanco, Stryker; Hannah Foley, J&J; Brianna Gabbard, restor3d;
- MR Working Group Update | Grant Baker, Arthrex and Lisa Boyle, Exalta
- What’s New on Capitol Hill: A Legislative and Regulatory Update | Kyle Sampson, King and Spalding
- Orthopedic Standards in Motion: ASTM F04.22 and ISO Updates | Leah Guenther, Vice Chair ASTM F04.22 Arthroplasty Subcommittee
- Quality Management System Updates and Recent Experiences | Christine Scifert and Dawn Norman, MRC Global
- Packaging and Labeling Updates: A Contract Packaging Perspective | Miki Velickovski and Jeffrey Goleta, Fruh Packaging
6:30-8:30PM | Welcome Reception | Hyatt Lobby Terrace
Tuesday, September 22 | FDA White Oak Campus
Roundtrip bus transportation will be provided from the Hyatt Regency to the FDA Campus.
8:00PM-5:00PM | FDA Sessions
- OHT6 Update | RDML Peat PhD, MPH
- Evidence Generation for Novel Medical Devices | Owen Faris PhD
- Accelerating Evidence Generation: From FDA Intent to Operational Execution | Amra Racic, Veeva
- DHT6 A Update | Jiping Chen MD, PhD, MPH
- DHT6 B Update | Laurence Coyne PhD
- DHT6 C Update | Ronald Jean PhD
- AI/LLM Session | S. Raymond Golish MD, PhD, MBA
- TAP Program Updates | Cynthia Chang
- FDA QMSR Inspections | Keisha R. Thomas MS, MHS, CQA, RAC
- Digital Health | Kathryn Drzewiecki PhD
- Additive Manufacturing | David Hwang PhD
- Advertising and Promotion | Deborah A. Wolf, JD
6:30PM | Group Dinner at Mon Ami Gabi
Wednesday, September 23 | Hyatt Regency Rooftop Room
8:00AM | Breakfast
8:30AM-1:00PM | Education Sessions
- Medical Device Servicing and Remanufacturing | Peter Weems, AdvaMed
- Latest Updates on PCCPs | Diane Johnson, J&J
- AI in the FDA-Regulated World: From Medical Devices to Regulatory Submissions | Milind Sawant PhD, AI2Z
- ISO 10993-1:2025: What’s Changed and What It Means for Orthopedic Devices | Lindsey Borton, Private Toxicology Consultant at Gradient
- Breakthrough Device Designation: Company Experiences | Moderator: Lindsay Stafford, Ceramtec; Panelists: Sharat Kusuma MD, JointMedica; Ryan Belaney, Phoenix Kinetics; and Katherine Cooper, King and Spalding
Full agenda will be available soon. Login to view details.
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Registration
Please login to view registration links.
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FDA Entry Requirements
The FDA has specific entrance requirements. You will not be permitted to enter the FDA Great Room without the appropriate identification (all attendees) and pre-submitted form (for Foreign Nationals). Please login to view the full requirements.
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