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Medtronic clears a robotic LigaSure vessel sealer for Hugo, nine months after the robot FDA clears Neptune Medical's Triton 1 robotic colonoscope after a 50-patient study FDA takes pathogen-agnostic sequencing to an advisory panel on November 19 CMS adds heart failure and COPD tracks to the ACCESS model, launching spring 2027 FDA posts a Class I recall of Medtronic's Bravo CF delivery device after 184 serious injuries FDA approves Abbott's Aveir VR Mini, 14 percent shorter than the current Aveir VR Mayo Clinic and Thermo Fisher launch Precure to build a million-specimen molecular dataset FDA opens a reliance portal so foreign regulators can lean on its device decisions Medtronic offers a 7 percent discount to push 80.1% of MiniMed onto its own shareholders Medtronic clears a robotic LigaSure vessel sealer for Hugo, nine months after the robot FDA clears Neptune Medical's Triton 1 robotic colonoscope after a 50-patient study FDA takes pathogen-agnostic sequencing to an advisory panel on November 19 CMS adds heart failure and COPD tracks to the ACCESS model, launching spring 2027 FDA posts a Class I recall of Medtronic's Bravo CF delivery device after 184 serious injuries FDA approves Abbott's Aveir VR Mini, 14 percent shorter than the current Aveir VR Mayo Clinic and Thermo Fisher launch Precure to build a million-specimen molecular dataset FDA opens a reliance portal so foreign regulators can lean on its device decisions Medtronic offers a 7 percent discount to push 80.1% of MiniMed onto its own shareholders

FDA program

FDA opens a reliance portal so foreign regulators can lean on its device decisions

MedDevice Startups Staff · 3 days ago · 2 min read · Via FDA

CDRH listed a Regulatory Reliance Portal for medical devices in its September 14 updates. The audience is other countries' regulators, not manufacturers. FDA defines reliance as the point where one authority takes into account and gives significant weight to an assessment another authority already performed.

The portal collects what FDA already publishes: PMA summaries, 510(k) clearance letters and summaries, De Novo classification orders, inspection records, registration and listing data, and post-market data from MAUDE and the recall database. It is aimed at authorities setting up a first reliance program as much as at ones already running one. Questions go to CDRHInternational@fda.hhs.gov.

None of this changes a US submission. It changes what the submission is worth abroad. The more of FDA's file a foreign reviewer can pull without asking the company for it, the more a clearance letter functions as the opening move in a market entry sequence rather than a single-country result.

Questions & Answers

What is the FDA CDRH Regulatory Reliance Portal for medical devices?

It is an FDA resource, listed in CDRH's September 14, 2026 updates, that collects the agency's public device information for foreign regulatory authorities so they can rely on FDA assessments instead of repeating a full review. FDA defines reliance as one authority taking into account and giving significant weight to another authority's assessment.

What FDA device information is on the reliance portal?

The portal points regulators to PMA summaries, 510(k) clearance letters and summaries, De Novo classification orders, inspection records, registration and listing data, and post-market data including MAUDE reports and recalls.

Do device manufacturers have to do anything for the FDA reliance portal?

No. The portal is aimed at regulatory authorities, not manufacturers, and draws on information FDA already publishes. Regulators with questions are directed to CDRHInternational@fda.hhs.gov.

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