The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS announces testing agreements; TGA slaps two companies for violations.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Brighter.
The U.S. FDA is no longer reviewing lab-developed tests (LDTs) under the emergency use authorization (EUA) program, which eliminates product liability protection for them under the Public Readiness and Emergency Preparedness (PREP) Act. Harvard’s Michael Mina said on an Oct. 30 press briefing that the PREP Act question could be extended to LDTs administratively even outside EUA review, a move he said is under consideration based on his communications with Assistant Secretary for Health Brett Giroir.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA posts list of essential devices, drugs; Members of Congress query NIH’s Collins on RADx program; Imminent malware threat reported; CDC posts telehealth report; CMS unveils seven AI competition finalists.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic Canada, Perkinelmer.
The PMA for the Neovasc Reducer device for treatment of drug-refractory angina faltered at an Oct. 27 U.S. FDA advisory committee, but it wasn’t for lack of support from star-power cardiologists. Gregg Stone, of the Cardiovascular Research Foundation, gave an impassioned plea for approval, pointing out that these patients have few options if they are poor candidates for bypass grafting or percutaneous coronary intervention. Stone said, “this is really a desperate patient cohort,” adding that a two-class improvement in angina severity “is a robust reduction.”
TORONTO – Whether it’s President Trump obtaining the drug Regeneron or COVID-19 test kits fast tracked in the U.S. and Canada, this has been the year of temporary emergency approvals for drugs and medical devices. What is sometimes overlooked are permanent programs like Canada’s Special Access Program and the U.S.’s Expanded Access Program, designed to provide therapeutics to patients who have exhausted every avenue for a cure or relief from a devastating disease.
If a new federal rule withstands politics and potential court challenges, U.S. health care prices may finally be freed from their historic black box. The Centers for Medicare & Medicaid Services, along with the Departments of Labor and the Treasury, issued the Transparency in Coverage final rule Oct. 29 requiring most private health plans to disclose pricing and cost-sharing information so Americans will know in advance how much they will have to pay for prescription drugs, medical devices and other health care products and services.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: ONC delays health IT compliance dates due to COVID-19; DOJ drops $8.1 million fine on Medtronic over FCA violation; CMS posts DME draft rule; NIH lays out final policy on data sharing; NICE posts two health technology assessments.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chf Solutions, Dia Imaging Analysis, Illuminoss Medical, Medtronic.
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