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DTSTART;TZID=America/Los_Angeles:20260720T120000
DTEND;TZID=America/Los_Angeles:20260731T200000
DTSTAMP:20260807T185448Z
CREATED:20260708T181844Z
LAST-MODIFIED:20260807T185448Z
UID:14264-1784548800-1785528000@osma.net
SUMMARY:2026 Virtual Summer Series
DESCRIPTION:Big news for the OSMA Summer Meeting\nWe’re excited to announce that registration is officially open for the OSMA Virtual Summer Series taking place between July 27 and August 7! This year’s series will feature six sessions covering key regulatory and professional development topics. \n  \n\nRegistration is FREE!\nAll Member Company and Strategic Partner employees are invited to attend.\nRegistration for Sessions 1-3 is open now\, with the remaining three sessions to be announced on a rolling basis.\n\n  \nTo view sessions and registration links\, please login to your account. \nClick here to create your Individual OSMA Member account. \nClick here to create your Individual OSMA Strategic Partner account.
URL:https://osma.net/event/2026-virtual-summer-series-2/
LOCATION:Maryland
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20260730T150000
DTEND;TZID=America/New_York:20260806T140000
DTSTAMP:20260817T174907Z
CREATED:20260708T181636Z
LAST-MODIFIED:20260817T174907Z
UID:14260-1785423600-1786024800@osma.net
SUMMARY:2026 Virtual Summer Series
DESCRIPTION:Big news for the OSMA Summer Meeting\nWe’re excited to announce that registration is officially open for the OSMA Virtual Summer Series taking place between July 30 and August 6! This year’s series will feature five sessions covering key regulatory topics. \n\nRegistration is FREE!\nAll Member Company and Strategic Partner employees are invited to attend.\nRegistration for all sessions is now open!\n\n_____________________________________________________________________________________ \nSession 1: Beyond Clinical Trials: Leveraging Real-World Evidence Throughout the Medical Device Lifecycle\nJuly 30\, 2026 | 3:00 PM ET \n \nThis insightful 60-minute session with Dr. Amelia Hufford\, the Co-founder and SVP of Clinical and Regulatory Science Operations for 3Aware\, will cover: \n– Current regulatory expectations for RWE in major global markets \n– How U.S. and EU approaches to RWD acceptance and evidence requirements compare \n– How RWD supports evidence generation across the medical device lifecycle \n– The benefits and challenges of using RWD for regulatory decision-making \nPresentation \nExecutive Summary \n_____________________________________________________________________________________ \nSession 2: TGA Requirements and Expectations for Inclusion of Orthopaedic Devices on the Australian Register of Therapeutic Goods (ARTG)\nAugust 3\, 2026 | 6:00 PM ET \n\n\n\nEdwina Burns and Jie Zhou from TGA will cover the importance of robust clinical evidence and its alignment with the requirements of the Essential Principles of the Australian Therapeutic Goods Act 1989. We will discuss reliance framework that recognises certificates from comparable overseas regulators to support orthopaedic medical device inclusion on the Australian Register of Therapeutic Goods (ARTG) that are designed to enable earlier patient access in Australia. The presentation will also give an update on Australia’s Unique Device Identification (UDI) requirements. \n\nEdwina Burns\, Medical Officer\, Devices Clinical Evaluation Section\nJie Zhou\, Technical Lead\, Devices Review Management Section\nManeesha Ram\, Associate Director of Regulatory Affairs at J&J MedTech ANZ\, will provide introductions.\n\nPresentation \nExecutive Summary \n_____________________________________________________________________________________\n\n\nSession 3: Canadian Regulatory Landscape \nAugust 4 | 11:00 AM ET \n \nJoin Nicholas Wilson from Johnson and Johnson as he provides an overview of the regulatory landscape\, highlights the latest updates\, and answers your questions. \nTopics include: \n\n\nRegulations \n\n\nGeneral Risk Based Classification \n\n\nNuanced Classification Rules \n\n\nSpecial Access and Custom-Made Devices \n\n\nTerms of Marketing Authorizations (Advertising) \n\n\nMDSAP ISO 13485 Certification and Regulatory Reliance \n\n\nIMDRF Submission Format \n\n\neSTAR Program \n\n\nPredetermined Change Control Plan (PCCP) \n\n\n  \nPresentation \nExecutive Summary \n_____________________________________________________________________________________ \nSession 4: OSMA Summer Business Meeting\nAugust 5 | 12:00 PM ET \n \nJoin OSMA President Ryan Belaney for a quick update on the latest OSMA news including the 2026 Fall Meeting at the FDA White Oak Campus\, the upcoming board elections\, an OAR update\, and highlights from the President’s Report. \nPresentation \nExecutive Summary \n_____________________________________________________________________________________ \nSession 5: Navigating Brazil’s Evolving Regulatory Landscape \nAugust 6 | 1:00 PM ET \n \nBrazil’s regulatory framework for medical devices continues to evolve\, making it essential for companies operating in the orthopaedic space to stay informed. This session with Karolyne Kikuchi will provide a practical look at Brazil’s regulatory environment and the journey companies can expect when bringing devices to market. \nTopics covered include:\n– Brazil overview\n– Regulatory landscape\n– The regulatory journey\n– Challenges and opportunities\n– Live Q&A \n  \nPresentation \nExecutive Summary
URL:https://osma.net/event/2026-virtual-summer-series/
LOCATION:Maryland
ATTACH;FMTTYPE=image/png:https://osma.net/wp-content/uploads/2026/07/INTRODUCING-THE-OSMA-VIRTUAL-SUMMER-SERIES.png
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BEGIN:VEVENT
DTSTART;TZID=America/New_York:20260921T120000
DTEND;TZID=America/New_York:20260923T130000
DTSTAMP:20261021T145322Z
CREATED:20260807T220557Z
LAST-MODIFIED:20261021T145322Z
UID:14326-1789992000-1790168400@osma.net
SUMMARY:OSMA 2026 Fall Meeting
DESCRIPTION:  \nPresentations and Executive Summary are now available. Login to view details. \nThank you for joining 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! \n  \n \n  \nAccommodations: \nThe Hyatt Regency is located in downtown Bethesda. Please login to view accommodation information. \n  \nAgenda\nMonday\, September 21 | Hyatt Regency Rooftop Room \n12:00PM | Lunch \n1:00-5:00PM | Educations Sessions \n\nOSMA and OAR Updates | Ryan Belaney\, Phoenix Kinetics; Lisa Boyle\, Exalta; Valerie Giambanco\, Stryker; Hannah Foley\, J&J; Brianna Gabbard\, restor3d;\nMR Working Group Update | Grant Baker\, Arthrex and Lisa Boyle\, Exalta\nWhat’s New on Capitol Hill: A Legislative and Regulatory Update | Kyle Sampson\, King and Spalding\nOrthopedic Standards in Motion: ASTM F04.22 and ISO Updates | Leah Guenther\, Vice Chair ASTM F04.22 Arthroplasty Subcommittee\nQuality Management System Updates and Recent Experiences | Christine Scifert and Dawn Norman\, MRC Global\nPackaging and Labeling Updates: A Contract Packaging Perspective | Miki Velickovski and Jeffrey Zoleta\, Fruh Packaging\n\n  \n6:30-8:30PM | Welcome Reception | Hyatt Lobby Terrace \n  \n \n  \nTuesday\, September 22 | FDA White Oak Campus \nRoundtrip bus transportation will be provided from the Hyatt Regency to the FDA Campus. \n8:00PM-5:00PM | FDA Sessions \n\nOHT6 Update | RDML Peat PhD\, MPH\nEvidence Generation for Novel Medical Devices | Owen Faris PhD\nAccelerating Evidence Generation: From FDA Intent to Operational Execution | Amra Racic\, Veeva\nDHT6 A Update | Jiping Chen MD\, PhD\, MPH\nDHT6 B Update | Laurence Coyne PhD\nDHT6 C Update | Ronald Jean PhD\nAI/LLM Session | S. Raymond Golish MD\, PhD\, MBA\nTAP Program Updates | Cynthia Chang\nFDA QMSR Inspections | Keisha R. Thomas MS\, MHS\, CQA\, RAC\nDigital Health | Kathryn Drzewiecki PhD\nAdditive Manufacturing | David Hwang PhD\nAdvertising and Promotion | Deborah A. Wolf\, JD\n\n  \n6:30PM | Group Dinner at Mon Ami Gabi \n  \n \n  \nWednesday\, September 23 | Hyatt Regency Rooftop Room \n8:00AM | Breakfast \n8:30AM-1:00PM | Education Sessions \n\nMedical Device Servicing and Remanufacturing | Peter Weems\, AdvaMed\nLatest Updates on PCCPs | Diane Johnson\, J&J\nAI in the FDA-Regulated World: From Medical Devices to Regulatory Submissions | Milind Sawant PhD\, AI2Z\nISO 10993-1:2025: What’s Changed and What It Means for Orthopedic Devices | Lindsey Borton\, Private Toxicology Consultant at Gradient\nBreakthrough Device Designation: Company Experiences | Moderator: Lindsay Stafford\, Ceramtec; Panelists: Sharat Kusuma MD\, JointMedica; Ryan Belaney\, Phoenix Kinetics;  and Katherine Cooper\, King and Spalding\n\n  \nFull agenda will be available soon.  Login to view details. \n  \n \n  \n_________________________________________________________________________________________ \nRegistration \nPlease login to view registration links. \n_________________________________________________________________________________________ \nFDA Entry Requirements\nThe 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. \n_________________________________________________________________________________________ \nIf you have any questions\, please reach out to mpc@osma.net. \nClick here to create your individual OSMA Member Account. \nClick here to create your individual OSMA Strategic Partner Account. \n  \n 
URL:https://osma.net/event/osma-2026-fall-meeting-2/
LOCATION:Hyatt Regency Downtown Bethesda\, One Bethesda Metro Center\, 7400 Wisconsin Ave\,\, Bethesda\, Maryland\, 20814
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20260921T120000
DTEND;TZID=America/New_York:20260923T133000
DTSTAMP:20261021T145204Z
CREATED:20260807T182531Z
LAST-MODIFIED:20261021T145204Z
UID:14313-1789992000-1790170200@osma.net
SUMMARY:OSMA 2026 Fall Meeting
DESCRIPTION:  \nThank you for joining us at the OSMA Fall Meeting 2026! \nAgenda and Presentations\nFull Agenda: Final OSMA 2026 Fall Meeting Agenda \nExecutive Summary: OSMA 2026 Fall Meeting Executive Summary \nNote: Presentations are linked below.  \nMonday\, September 21 | Hyatt Regency Rooftop Room \n\n\nOSMA and OAR Updates | Ryan Belaney\, Phoenix Kinetics; Lisa Boyle\, Exalta; Valerie Giambanco\, Stryker; Hannah Foley\, J&J; Brianna Gabbard\, restor3d;  \n\n\nMR Working Group Update | Lisa Boyle\, Exalta \n\n\nWhat’s New on Capitol Hill: A Legislative and Regulatory Update | Kyle Sampson\, King and Spalding \n\n\nOrthopedic Standards in Motion: ASTM F04.22 and ISO Updates | Leah Guenther\, Vice Chair ASTM F04.22 Arthroplasty Subcommittee \n\n\nQuality Management System Updates and Recent Experiences | Christine Scifert and Dawn Norman\, MRC Global \n\n\nPackaging and Labeling Updates: A Contract Packaging Perspective | Miki Velickovski and Jeffrey Zoleta\, Fruh Packaging \n\n\n  \n \n  \nTuesday\, September 22 | FDA White Oak Campus \nNote: Presentations are not available for FDA sessions. \n8:00PM-5:00PM | FDA Sessions \n\n\nOHT6 Update | RDML Peat PhD\, MPH \n\n\nEvidence Generation for Novel Medical Devices | Owen Faris PhD \n\n\nAccelerating Evidence Generation: From FDA Intent to Operational Execution | Amra Racic\, Veeva \n\n\nDHT6 A Update | Jiping Chen MD\, PhD\, MPH \n\n\nDHT6 B Update | Laurence Coyne PhD \n\n\nDHT6 C Update | Ronald Jean PhD \n\n\nAI/LLM Session | S. Raymond Golish MD\, PhD\, MBA \n\n\nTAP Program Updates | Cynthia Chang \n\n\nAdditive Manufacturing | David Hwang PhD \n\n\nBest Practices for PCCPs for Medical Devices | Kathryn Drzewiecki PhD \n\n\nFDA QMSR Inspections | Keisha R. Thomas MS\, MHS\, CQA\, RAC \n\n\nAdvertising and Promotion | Deborah A. Wolf\, JD \n\n\n  \n6:30PM | Group Dinner at Mon Ami Gabi \n  \n \n  \nWednesday\, September 23 | Hyatt Regency Rooftop Room \nNote: Presentations are linked below. Executive Summaries will be available the week of October 12. \n\n\nMedical Device Servicing and Remanufacturing | Peter Weems\, AdvaMed \n\n\nLatest Updates on PCCPs | Diane Johnson\, J&J \n\n\nAI in the FDA-Regulated World: From Medical Devices to Regulatory Submissions | Milind Sawant PhD\, AI2Z \n\n\nISO 10993-1:2025: What’s Changed and What It Means for Orthopedic Devices | Lindsey Borton\, Private Toxicology Consultant at Gradient \n\n\nBreakthrough Device Designation: Company Experiences | Moderator: Lindsay Stafford\, Ceramtec; Panelists: Sharat Kusuma MD\, JointMedica; Ryan Belaney\, Phoenix Kinetics;  and Katherine Cooper\, King and Spalding \n\nAdditional Law 360 Paper Referenced in the Meeting: New CMS Medical Device Pathway May Have Limited Effect\n\n\n\n  \n \n  \n_________________________________________________________________________________________ \nRegistration \nRegistration is closed. \nPlease 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! \n_________________________________________________________________________________________ \nAccommodations: \nThe Hyatt Regency is located in downtown Bethesda. While we do not have a hotel block\, accommodations can be found at the Hyatt Regency and surrounding hotels. \nSELF PARKING\nFor those who prefer to self-park\, the ABM Parking Garage is located directly beneath the hotel (please\nnote this facility is not operated by Hyatt Regency Bethesda). The overnight parking fee is for a 24-\nhour period\, and validation through the hotel ensures access to in-and-out privileges. \n\n\nTo self-park\, please follow the signs leading to the P3 BALLROOM level of the garage.\n\nParking on the P3 level is recommended to prevent any potential difficulties when entering and exiting the hotel.\n\n\n\nUpon parking\, please enter through the Ballroom Double Door Entrance and they will walk directly into their event space. \nShould you require further guidance\, we have provided a helpful video detailing the navigation to P3 parking.\nPlease click here “Navigating to P3 Parking Video” \nFDA Day Transportation and Security\n🚍 Bus Transportation:  \n\nIf you signed up for bus transportation\, please arrive at the Hyatt Regency lobby by 7:00am.\nThe bus will transport attendees directly to Building 1.\nThe bus will return attendees to the Hyatt Regency after the meeting.\n\n🚘 Car Transportation: \n\nArrive at FDA before 7:45AM\nUse the Michelson Road entrance from New Hampshire Avenue to access the vehicle screening facility.\nPark in one of the Visitor Parking Lots\nTake the shuttle or short walk to Building 1\n\n🚘 Uber Transportation \n\nArrive at FDA by 7:50AM\nProceed directly to the Building 1 Circle off Mahan Road.\n\nOnce you arrive at Building 1\, you will proceed through security. You will need to have the proper identification (REAL ID\, passport\, LPR card). After going through security\, please wait for your OHT6 escort. \n  \nFor additional details on visiting the FDA campus visit: \nhttps://www.fda.gov/about-fda/visitor-information/getting-fda \nhttps://www.fda.gov/about-fda/visitor-information/visitor-parking-and-campus-map \n  \n \n  \nFDA Entry Requirements\nThe 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). \n\n\n\nUS citizens and Lawful Permanent Residents\n\n\nNo form or prior approval is required to enter the Great Room.\n\n\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).\nVisitors must display their visitor badge at all times.\nVisitors are under observation and escorted at ALL times.\n\nDiscovery of unescorted visitor(s) can result in administrative action.\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 ID is accepted for LPRs.\nFollow guidance listed above\, as described for U.S. Citizens.\n\n\n\n\nForeign National (FN) Visitors: A Foreign National Visitor Data Request (FNVDR) form is required. \n \n\n\nSubmit the filled Foreign National Visitor Data Request Form\, due to OHT6 NLT COB\, September 14\, 2026\n\n(POC: ester.hatton@fda.hhs.gov\, copy: laurence.coyne@fda.hhs.gov) \n\nDo not submit FNVDR form more than 30 calendar days in advance (before August 24\, 2026).\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)\nFN are allowed in PUBLIC AREAS ONLY. FN are NOT allowed in employee offices or labs\nConfirm visitors display visitor badge at all times.\nVisitors are under observation and escorted at all times.\n\nDiscovery of unescorted visitor(s) can result in administrative action.\n\n\n\n  \nIf you have any questions\, please reach out to mpc@osma.net.
URL:https://osma.net/event/osma-2026-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/2026/08/2026-Fall-STD.png
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