Tag Archives: clinical data

Bridging Regulatory & Reimbursement

Everybody is looking for Evidence — Bridging Regulatory & Reimbursement: Strategies for Success

By Christy Sheehy, PhD, Jenny Levinson
Bridging Regulatory & Reimbursement

As medical technology products and services move through the development pipeline, they face the challenge of both showing safety and efficacy for regulatory approval and articulating the value of the diagnostic, treatment or monitoring technology to obtain reimbursement from payers. A 2024 MedExec Women Conference panel highlighted strategies to bridge the evidence needs for regulatory approval and reimbursement to more efficiently bring products to market.

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FDA Issues Three New Draft Guidances on the 510(k) Program

By MedTech Intelligence Staff
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The FDA has issued three new draft guidances related to the 510(k) submissions program, including Best Practices for Selecting a Predicate Device, Use of Clinical Data in Premarket Notification and Evidentiary Expectations for Implant Devices. The agency is accepting comments and will host a webinar for stakeholders on October 26, 2023, to provide more information on the guidances.

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