FDA For-Cause Inspections Targeting Medical Device Manufacturers: Navigating the Process, Mitigating Risks
Join Hogan Lovells in this webinar will examine FDA for-cause inspections as they relate to medical device manufacturers.
Regulatory Affairs
Learn more about our Regulatory Affairs work.
AdvaMed® Comment Letter to ASTP/ONC: Accelerating AI Adoption in Clinical Care
AdvaMed’s® Comment Letter to ASTP/ONC, outlines concrete policy reforms across FDA oversight, CMS payment pathways, and HIPAA data-sharing rules to accelerate patient access to AI-enabled medical technologies. As AI-enabled medical…
i-GENTIC AI Launches Context-Aware MedTech Agents to Strengthen FDA 510(k) Submission Consistency
PALO ALTO, Calif., Feb. 11, 2026 i-GENTIC AI today announced a new suite of context-aware, multilingual MedTech agents designed to help medical device manufacturers improve the quality and consistency of…
Why Practical FDA Submissions Training Makes the Difference
Explore AdvaMed’s Medical Device Submissions Workshop Series from practical submission strategies to live expert insights you can apply immediately.
AdvaMed® Announces Melissa Torres as New Executive Vice President of Technology and Regulatory Affairs
WASHINGTON—AdvaMed, the MedTech Association®, today announced Melissa Torres is the new Executive Vice President of Technology and Regulatory Affairs. Torres succeeds Janet Trunzo, who retired after 30 distinguished, productive years withAdvaMed®.
AdvaMed® Receives RAPS Accreditation for Medical Device Submissions Workshop Series (February 2026 in Washington, D.C.)
WASHINGTON, D.C.—AdvaMed, the world’s largest trade association representing medical technology innovators, announced that its Medical Device Submissions Workshop Series (February 23-27 in Washington, D.C.) has been officially approved for RAC…
Honoring Janet E. Trunzo: A Legacy That Shaped Modern Medtech Regulation
After 30 years atAdvaMed®, Janet E. Trunzo, Senior Advisor to the President and Senior Executive Vice President of Technology and Regulatory Affairs, will retire on January 31, 2026. Her tenure…
Strengthen Your IDE Strategy at AdvaMed’s IDE Submissions Workshop
Gain in-depth IDE submission training, meaningful face time with FDA and regulatory leaders, and RAPS accreditation credits at AdvaMed’s IDE Submissions Workshop.
AdvaMed® Names Brian J. Blaser, QuidelOrtho President and CEO, Chair of AdvaMedDx Board of Directors
WASHINGTON, D.C.—AdvaMed, the MedTech Association®, today announced that Brian Blaser, president and CEO of QuidelOrtho, will serve as the next chair of the AdvaMedDx Division Board of Directors, succeeding Thierry Bernard, CEO of QIAGEN. AdvaMedDx represents more…
Medical Imaging Division Announces Rich Fabian as New Board Chair
WASHINGTON, D.C.—AdvaMed, the MedTech Association®, today announced that Rich Fabian, president and CEO of FUJIFILM Sonosite, will serve as the chair of the Medical Imaging division’s board of directors. He will succeed David Pacitti, CEO of Avanos Medical and former president and…