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United States

Set Alert for Policy and Regulation United States

FDA Calling: US Agency Again Asks Companies To Open Doors For Educational Purposes

In its continuing bid to better understand how industry and other stakeholders operate in the real world and learn to improve its own practices, FDA is again asking volunteers to let staffers come observe organizations for a day or two as part of the device center's Experiential Learning Program.

Regulation FDA Medical Device
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Latest From United States, Policy & Regulation

Industry Asks CMS To Allow More Medtech Input, Longer-Term Metrics In Bundled Pay Models

Industry groups told the US Medicare agency it should seek the input of a broader array of stakeholders – including medtech companies – in developing future episode-of-care pay models. They also argued that participation in the programs should be voluntary, and that the pay models should account for patient outcomes longer than 90 days following initial care. The responses came in comments to CMS following its proposal to scale back its joint replacement bundled payments program and eliminate a cardiac-care version.

Reimbursement Market Access

Minnesota Lobby Group Hires Top State House Staffer

The Medical Alley Association hired the former Minnesota House Speaker's legislative director Bobby Patrick to lead lobbying efforts in the state.

Policy Medical Device

FDA Final Guidance On Drug/Device Classifications Misses The Mark, Attorneys Say

The final guidance adds some requested clarifications, but does not appear to address the US agency's tendency to designate products as drugs over devices, industry attorneys argue.

Regulation Combination Products

AdvaMed CEO Supports Potential HHS Secretary Nominee Azar

AdvaMed CEO Scott Whitaker says Alex Azar, who is reportedly the top candidate to be nominee for US Health and Human Services secretary, would be ideal for the job with his extensive experience at the department.

Policy Medical Device

Patients Want Industry To Minimize Burdens, Augment Comforts Of Device Trial Participation

Patients and patient advocacy groups at the US FDA's inaugural Patient Engagement Advisory Committee meeting said they need sponsors to minimize the burdens and augment the comforts of trial participation, and get reports on outcomes along the way. Meanwhile, industry groups worried about revealing too much confidential business information, and biasing trial outcomes.

Advisory Committees Clinical Trials

New Connected-Health Standards Signal US FDA's Future Thinking

Standards organizations say software and informatics standards recently recognized by US FDA are a sign of the technologies the agency expects to tackle in future product applications and a signal to industry about priorities.

Digital Health Standards
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