IMPORTANT UPDATE: It is with sincere regret that we must inform you that the OSMA 2025 Fall Meeting (October 22-23, 2025) has been cancelled due to the ongoing federal government shutdown.
Why This Decision Was Necessary:
This unexpected situation has created circumstances beyond our control, as we have just received this new communication from the FDA:
- The FDA has informed us they cannot host Day 2 at the FDA White Oak Campus due to the shutdown
- FDA speakers are now unable to participate
- A significant portion of our program content relies on FDA participation and expertise
Given that FDA involvement is central to the educational value of this meeting, the OSMA Board of Directors has made the difficult decision to cancel rather than proceed with a substantially altered program.
Your Registration & Refund:
All EventBrite registrations will be cancelled by OSMA, and you will receive a full refund. You do not need to take any action. Refunds will be processed automatically within 7-10 business days and will appear in your original payment method.
**Please read all EventBrite Communications and communications from secretary@osma.net as any additional information will first be sent via these channels and may be filtered to your junk folder.**
Hotel Reservation Update:
The Bethesda North Marriott has officially cancelled the hotel block.
- If you booked your room through the hotel block link, you do not need to take any further action. Your reservation has been cancelled.
- If you booked your room outside of the hotel block, you will need to cancel your reservation.
Virtual Business Meeting in Q4 2025:
While we cannot proceed with the full Fall Meeting, OSMA will host a virtual business meeting in Q4 2025 to address critical organizational matters, including:
- Board seat elections – Voting for open board positions will proceed as scheduled
- Officer reports and updates
- Essential business matters requiring member action
Details regarding the date, time, and virtual meeting platform will be communicated separately to all OSMA members. The meeting will be open to all members, but only OSMA voting members will be eligible to participate in the board seat vote.
Looking Ahead:
The FDA has expressed strong interest in postponing the educational sessions to spring 2026 when normal government operations resume. We are committed to rescheduling and will communicate details about a Spring Meeting as soon as they are available. Your registration and payment of fees for this cancelled event will not be carried forward automatically, but we hope you will join us when we reconvene.
Our Sincere Apologies:
This cancellation comes at a tremendous cost to OSMA, both financially and in terms of the missed opportunity to bring our community together. However, we believe this is the right decision given the circumstances. We share your disappointment and frustration with this unprecedented situation.
The OSMA Board of Directors thanks you for your understanding and continued support during this challenging time. We remain committed to serving the orthopedic device community and look forward to gathering together in spring 2026.
If you have questions or concerns, please contact us at mpc@osma.net
Sincerely,
Ryan Belaney
President, OSMA
On behalf of the OSMA Board of Directors
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Join us for the OSMA Fall Meeting at the Bethesda North Marriott Hotel and Conference Center on Wednesday, October 22 and the FDA White Oak Campus on Thursday, October 23!
Registration: EventBrite Registration
Hotel Block: Although the hotel block has ended, rooms are still available at the Bethesda North Marriott Hotel and Conference Center.
Agenda: The Full Agenda for the Fall Meeting is now available. Please send speaker questions to mpc@osma.net. Please see below for additional session information.
Transportation: Transportation to/from FDA will be arranged (charter bus) based on registration numbers. If you require special accommodations or will be taking private transportation, please contact mpc@osma.net. Additional parking and visitor information can be found below.
FDA Entrance Requirements: Please note the type of ID required to enter the FDA facility on October 23, 2025. Foreign nationals must have the required paperwork submitted by October 14, 2025. If you do not have the appropriate ID or you have not filed the appropriate form, you will not be able to enter the FDA building.
| US citizens and Lawful Permanent Residents |
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| Lawful Permanent Resident (LPR) aka “Green Card Holder” of the United States |
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| Foreign National (FN) Visitors: A Visitor Request Form is required.
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FDA Parking and Visitor Information:
The FDA has advised OSMA members to follow all the instructions here https://www.fda.gov/about-fda/visitor-information
Entrance and Parking
- If you click on the Visitor Parking and Campus Map (https://www.fda.gov/about-fda/visitor-information/visitor-parking-and-campus-map), there’s a section showing where attendees will enter using the Michelson Road entrance for a vehicle screening. Visitor parking is right off that entrance. You can park in Northwest Surface Lots 1, 3, and 4.
Shuttle and Screening
- There’s a parking lot shuttle (https://www.fda.gov/about-fda/getting-fda/fda-shuttle-bus) that you can take to Building 1. This is where the OSMA charter bus will drop everyone off, and everyone will proceed through security screening to the Great Room (Building 31).
Agenda Overview:
WEDNESDAY, OCTOBER 22- Bethesda North Marriott Hotel and Conference Center
We will kick off the day with the OSMA Business Meeting followed by Education Sessions focusing on:
- Navigating FDA Submissions in a Changing Environment: Janice Hogan, Hogan Lovells
- The changing environment and reduced staffing and resources present new challenges for FDA submissions. This presentation will address how these changes are impacting FDA submission reviews. Strategies for optimizing FDA interactions in a resource-constrained environment will be discussed, with recommendations for best practices.
- Your Standards Snapshot: What’s New and Key Insights in ASTM and ISO Standards: Jason Steffens, Endolab, and Leah Guenther
- This session offers an overview of recent updates and upcoming changes to standards developed by the ASTM Subcommittee on Arthroplasty (F04.22) and the ISO Committee on Implants for Surgery – Bone and Joint Replacements (TC 150 SC4).
- Innovation in Clinical Study Design: Nick Giokas, MCRA
- Reimbursement Strategies: John D. McDermott, Jr., MBA, MCRA
- Clinical Data in 510k’s: Michael Coladonato, MCRA
- Unboxing Orthopedics: Why Packaging Can Make or Break Safety: Christina Mendat, PhD, Eurofins
- In this session, Christina will share case studies illustrating how packaging design can make or break not only a product but also trust and safety in the operating room. Attendees will learn why packaging is not just a container, but a critical part of the user interface that must be designed, tested, and evaluated with the same rigor as the device itself.
THURSDAY, OCTOBER 23- FDA White Oak Campus
On the second day of the meeting, we will leave the Bethesda North Marriott as a group and travel to the FDA White Oak Great Room. Here we will join with FDA employees to discuss topics such as:
- Office of Orthopedic Devices (OHT6) Opening Remarks: RDML Raquel Peat, PhD, MPH, FDA
- Quality Culture: Keisha Thomas MS, MHS, CQA, RAC, FDA
- Building a Sustainable Quality Culture in FDA-Regulated Industries: Amra Racic, Veeva Systems
- Quality Culture is a pervasive topic in FDA-regulated industries, frequently discussed on professional platforms and at conferences. This session will explore how sustainable quality outcomes are achieved through established methodologies and consistent execution. We’ll delve into the concept of Quality System maturity as a key indicator of business process consistency and reliability. Crucially, we’ll examine the pivotal role of leadership in shaping quality culture, emphasizing how a leader’s values and beliefs about quality, communicated both verbally and non-verbally, directly influence the entire organization.
- DHT 6A Update: Jiping Chen M.D., Ph.D., FDA
- DHT 6B Update: Ronald Jean Ph.D., FDA
- DHT 6C Update: Laurence Coyne, Ph.D., FDA
- Additive Manufacturing: David Hwang, Ph.D. and Jay Kadakia, M.S.*, FDA
- TAP Program Updates: Cynthia Chang, FDA
- Corrosion Testing for Orthopedic Devices: Stephanie Smith, Ph.D.*, FDA
- Use of AI in CDRH: S. Raymond Golish, M.D., Ph.D., MBA, FDA
- Quantifying an Art: Industry Use of Data & AI to Improve Spine Surgery: Andrew Fields, Medtronic
- Biocompatibility Updates: Aprajita Garg, Ph.D. and Berk Oktem Ph.D., FDA
- When Change is the Only Constant: Updates to ISO 10993-1 and Other Hot Topics in Biocompatibility: Lindsey Borton, Gradient Corp
- Biocompatibility Panel Discussion:
- Moderator- Ron Brown, Risk Science Consortium, LLC
- Panelists- Lindsey Borton, Gradient Corp, Aprajita Garg, Ph.D., Paul Turner, Ph.D., Carole Wolfe, Ph.D., Berk Oktem, Ph.D., FDA
