AdvaMed Statement on FDA-USAID India Regulatory Session

WASHINGTON, D.C. - AdvaMed, the Medtech Association, released the following statement thanking the FDA Center for Radiological Health (CDRH) for recently hosting an event in New Delhi to discuss regulatory policies and best practices for ensuring medical technology reaches patients. The event, called "Minds to Markets: Regulatory Considerations in Med-Tech," advances US-India cooperation on medtech supply chain through greater regulatory alignment.

"India is a critical partner in medtech, and events like this provide valuable opportunities to further align our regulatory frameworks and standards so that we can innovate, grow, and better serve patients in both countries and around the globe," said Scott Whitaker, AdvaMed President and CEO. "We thank FDA and USAID for organizing this event and welcoming our India Regulatory Subgroup Chair Asok Kumar as a panelist to discuss a range of issues facing the medtech industry in the United States and India. I also want to thank U.S. Ambassador to India Eric Garcetti for attending this important event and recognizing the role medtech plays in the health care system."

The event, which was held on Friday, April 12, in New Delhi, India, included panels on topics such as FDA's approach to ensuring the safety and efficacy of medical technology, medtech innovation, and patient access. FDA regulators also discussed regulation of medical devices, the important role of the International Medical Device Regulators Forum (IMDRF), Artificial Intelligence and Machine Learning (AI/ML), innovation in devices, and regulatory harmonization and reliance in practice.

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