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DTSTART;TZID=America/Los_Angeles:20251022T080000
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UID:13768-1761120000-1761238800@osma.net
SUMMARY:OSMA 2025 Fall Meeting
DESCRIPTION: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. \nWhy This Decision Was Necessary: \nThis unexpected situation has created circumstances beyond our control\, as we have just received this new communication from the FDA: \n\nThe FDA has informed us they cannot host Day 2 at the FDA White Oak Campus due to the shutdown\nFDA speakers are now unable to participate\nA significant portion of our program content relies on FDA participation and expertise\n\nGiven 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. \nYour Registration & Refund: \nAll 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. \n**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.** \nHotel Reservation Update: \nThe Bethesda North Marriott has officially cancelled the hotel block. \n\nIf you booked your room through the hotel block link\, you do not need to take any further action. Your reservation has been cancelled.\nIf you booked your room outside of the hotel block\, you will need to cancel your reservation.\n\nVirtual Business Meeting in Q4 2025: \nWhile we cannot proceed with the full Fall Meeting\, OSMA will host a virtual business meeting in Q4 2025 to address critical organizational matters\, including: \n\nBoard seat elections – Voting for open board positions will proceed as scheduled\nOfficer reports and updates\nEssential business matters requiring member action\n\nDetails 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. \nLooking Ahead: \nThe 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. \nOur Sincere Apologies: \nThis 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. \nThe 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. \nIf you have questions or concerns\, please contact us at mpc@osma.net \nSincerely\, \nRyan Belaney\nPresident\, OSMA\nOn behalf of the OSMA Board of Directors \n  \n********************************************************************************************* \n  \nJoin 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! \nRegistration: EventBrite Registration \nHotel Block: Although the hotel block has ended\, rooms are still available at the Bethesda North Marriott Hotel and Conference Center. \nAgenda:  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. \nTransportation: 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. \nFDA 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. \n\n\n\nUS citizens and Lawful Permanent Residents\n\n\nNo form or prior approval is required to enter the Great Room.\nThe Visitor must present a VALID (REAL ID compliant) government issued PHOTO identification.\nAn FDA staff will be assigned to escort every 10 U.S. Citizen visitors (1:10).\nConfirm the visitor(s) displays their visitor badge at all times.\nVisitors MUST be under observation and escorted at ALL times. Discovery of unescorted visitor(s) can result in administrative action.\n\n\n\n\nLawful Permanent Resident (LPR) aka “Green Card Holder” of the United States\n\n\nNo form or prior approval is required to enter the Great Room.\nLPR Visitors must show their valid LPR card to enter (no photocopies). No other form of is accepted for LPRs.\nFollow guidance listed above\, as described for U.S. Citizens.\n\n\n\n\nForeign National (FN) Visitors: A Visitor Request Form is required. \n \n\n\nFilled (typed) Foreign National Visitor Data Request Form\, due to OHT6 no later than the close of business on October 14\, 2025.\n\nFDA Foreign National Visitor Data Request Formmay be directly submitted to ester.hatton@fda.hhs.gov\nForms should be sent no earlier than September 23\, 2025\n\nDo not submit more than 30 calendar days in advance.\n\n\nPlease contact jamie.macdougall@outlook.com with any questions\n\n\nA passport is the ONLY accepted form of identification for FN visitors. Inform each visitor to bring their passport.\nVisitors without the EXACT passport provided on the Visit Request Form WILL BE DENIED ENTRY. No exceptions.\nAn FDA staff will escort every 5 FN visitors (1:5).\nPUBLIC AREAS ONLY. No employee offices or labs.\nConfirm the visitor(s) displays their visitor badge at all times.\nVisitors MUST be under observation and escorted at ALL times. Discovery of unescorted visitor(s) can result in administrative action.\n\n\n\n\n\nFDA Parking and Visitor Information: \nThe FDA has advised OSMA members to follow all the instructions here https://www.fda.gov/about-fda/visitor-information \n    Entrance and Parking \n\nIf 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.\n\n    Shuttle and Screening \n\nThere’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).\n\n  \nAgenda Overview:  \n\n\n\n\n\n\n\n\n\n\n\n  \nWEDNESDAY\, OCTOBER 22- Bethesda North Marriott Hotel and Conference Center \nWe will kick off the day with the OSMA Business Meeting followed by Education Sessions focusing on: \n\nNavigating FDA Submissions in a Changing Environment: Janice Hogan\, Hogan Lovells\n\nThe 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.\n\n\nYour Standards Snapshot: What’s New and Key Insights in ASTM and ISO Standards: Jason Steffens\, Endolab\, and Leah Guenther\n\nThis 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).\n\n\nInnovation in Clinical Study Design: Nick Giokas\, MCRA\nReimbursement Strategies: John D. McDermott\, Jr.\, MBA\, MCRA\nClinical Data in 510k’s: Michael Coladonato\, MCRA\nUnboxing Orthopedics: Why Packaging Can Make or Break Safety: Christina Mendat\, PhD\, Eurofins\n\nIn 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.\n\n\n\n  \n\n\n\n\n\n\n\n\n\n\n\n  \nTHURSDAY\, OCTOBER 23- FDA White Oak Campus \nOn 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: \n\nOffice of Orthopedic Devices (OHT6) Opening Remarks: RDML Raquel Peat\, PhD\, MPH\, FDA\nQuality Culture: Keisha Thomas MS\, MHS\, CQA\, RAC\, FDA\nBuilding a Sustainable Quality Culture in FDA-Regulated Industries: Amra Racic\, Veeva Systems\n\nQuality 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.\n\n\nDHT 6A Update: Jiping Chen M.D.\, Ph.D.\, FDA\nDHT 6B Update: Ronald Jean Ph.D.\, FDA\nDHT 6C Update: Laurence Coyne\, Ph.D.\, FDA\nAdditive Manufacturing: David Hwang\, Ph.D. and Jay Kadakia\, M.S.*\, FDA\nTAP Program Updates: Cynthia Chang\, FDA\nCorrosion Testing for Orthopedic Devices: Stephanie Smith\, Ph.D.*\, FDA\nUse of AI in CDRH: S. Raymond Golish\, M.D.\, Ph.D.\, MBA\, FDA\nQuantifying an Art: Industry Use of Data & AI to Improve Spine Surgery: Andrew Fields\, Medtronic\nBiocompatibility Updates: Aprajita Garg\, Ph.D. and Berk Oktem Ph.D.\, FDA\nWhen Change is the Only Constant: Updates to ISO 10993-1 and Other Hot Topics in Biocompatibility: Lindsey Borton\, Gradient Corp\nBiocompatibility Panel Discussion:\n\nModerator- Ron Brown\, Risk Science Consortium\, LLC\nPanelists- Lindsey Borton\, Gradient Corp\, Aprajita Garg\, Ph.D.\, Paul Turner\, Ph.D.\, Carole Wolfe\, Ph.D.\, Berk Oktem\, Ph.D.\, FDA\n\n\n\n  \n\n\n\n\n \n 
URL:https://osma.net/event/osma-2025-fall-meeting/
LOCATION:Hyatt Regency Downtown Bethesda\, One Bethesda Metro Center\, 7400 Wisconsin Ave\,\, Bethesda\, Maryland\, 20814
ATTACH;FMTTYPE=image/png:https://osma.net/wp-content/uploads/2025/08/Copy-of-Corporate-Registration-is-Open-1.png
ORGANIZER;CN="Orthopaedic Surgical Manufacturers Association":MAILTO:mpc@osma.net
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20251022T080000
DTEND;TZID=America/Los_Angeles:20251023T170000
DTSTAMP:20251016T161220Z
CREATED:20250818T024556Z
LAST-MODIFIED:20251016T161220Z
UID:13800-1761120000-1761238800@osma.net
SUMMARY:OSMA 2025 Fall Meeting
DESCRIPTION: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. \nWhy This Decision Was Necessary: \nThis unexpected situation has created circumstances beyond our control\, as we have just received this new communication from the FDA: \n\nThe FDA has informed us they cannot host Day 2 at the FDA White Oak Campus due to the shutdown\nFDA speakers are now unable to participate\nA significant portion of our program content relies on FDA participation and expertise\n\nGiven 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. \n**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.** \nThe 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. \nFor additional information\, please log into the member website. \n********************************************************************************************** \nJoin 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! \nRegistration: Please sign into your OSMA account to view registration link.  If you need to create an OSMA account\, please follow these tutorials: Member Account\, Strategic Partner Account\, Fellows Account \nHotel Block: Rooms have been reserved at the Bethesda North Marriott Hotel and Conference Center for $289 per night plus taxes\, fees.  Hotel block ends September 29\, 2025.  Limited number of rooms available.  Please sign into your OSMA account to view registration link. \nFDA 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.  Please sign into your OSMA account to view FDA Entrance Requirements documents. \nTransportation to/from FDA will be arranged (charter bus) based on registration numbers. If you require special accommodations or will be taking private transportation\, feel free to contact mpc@osma.net. \nAgenda Overview:  \n\n\n\n\n\n\n\n\n\n\n\nWEDNESDAY\, OCTOBER 22- Bethesda North Marriott Hotel and Conference Center \nWe will kick off the day with the OSMA Business Meeting followed by Education Sessions focusing on: \n\nCapitol Hill Updates\nISO/ASTM Updates\nInnovation in Clinical Study Design\nReimbursement Strategies\nClinical Data in 510k’s\nHuman Factors\n\n  \n\n\n\n\n\n\n\n\n\n\n\nTHURSDAY\, OCTOBER 23- FDA White Oak Campus \nOn 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: \n\nOHT-6 Updates\nBuilding a Sustainable Quality Culture in FDA-Regulated Industries\nDHT-6 Updates\nAdditive Manufacturing\nTAP Program Updates\nEvidentiary Expectations for 510k Devices\nUse of AI in CDRH/Industry\nBiocompatibility (Updates and Panel Discussion with Key Industry and FDA Speakers)\n\n  \n\n\n\n\n \nFull agenda coming soon!
URL:https://osma.net/event/osma-2025-fall-meeting-2/
LOCATION:Hyatt Regency Downtown Bethesda\, One Bethesda Metro Center\, 7400 Wisconsin Ave\,\, Bethesda\, Maryland\, 20814
ORGANIZER;CN="Orthopaedic Surgical Manufacturers Association":MAILTO:mpc@osma.net
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