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The Latest in Regulatory and Reimbursement
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Biocom California published a new resource explaining CMS’ Transitional Coverage for Emerging Technologies pathway. FDA’s Center for Devices and Radiological Health (CDRH) has a new director and released its 2025 proposed guidance agenda. CDRH also launched a new effort to increase clinical trial transparency and diversity. FDA’s Center for Drug Evaluation and Research (CDER) published its report for the Accelerated Rare disease Cures (ARC) program. New provisions from the Inflation Reduction Act are taking effective for all Medicare plans.
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Dr. Tarver Announced as New CDRH Director
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Dr. Michelle Tarver will be FDA’s next director of the Center for Devices and Radiological Health (CDRH). Dr. Tarver has been with the agency for over 15 years and she previously held the role of Deputy Center Director.
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Biocom California Publishes TCET Resource
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CDRH Releases 2025 Proposed Guidance Agenda
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CDRH has released its fiscal year 2025 proposed guidance agenda outlining guidance that the center intends to publish, develop and receive feedback on to revise or withdraw. |
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CDER Publishes Annual Rare Disease Cures Report
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CDER’s Accelerated Rare disease Cures (ARC) program published a new annual report discussing internal CDER workgroup efforts, projects, and scientific and regulatory initiatives. |
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CDRH Pilots Device Trial Participation Snapshots
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To increase clinical trial transparency and diversity, CDRH is providing device trial participation snapshots highlighting a device’s intended use, benefits and risks and the diversity in trial participation. |
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Medicare Open Enrollment & New IRA Provisions for Plans
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Medicare Open Enrollment is currently open through December 15 and Medicare plans are subject to new coverage changes, such as a $2,000 cap on out-of-pocket drug costs, as a result of the Inflation Reduction Act (IRA).
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Request for Comments
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Biocom California welcomes feedback from members on the following draft guidance document. Click here to submit comments via email. |
► Predetermined Change Control Plans for Medical Devices
FDA’s draft guidance proposes a policy for Predetermined Change Control Plans (PCCPs) and includes recommendations on the information to include in a PCCP in a device marketing submission.
- A PCCP is the documentation describing what modifications will be made to a device and how the modifications will be assessed.
- A PCCP should describe the planned device modifications, the methodology to develop, validate and implement those modifications, and an assessment of the impact of those modifications.
- FDA reviews the PCCP as part of a marketing submission and the recommendations in this draft guidance apply to devices reviewed through the 510(k), De Novo and PMA pathways.
This guidance may be of interest to device manufacturers.
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Upcoming Regulatory and Reimbursement Events:
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Featured Members
Congratulations to Biocom California member, Pfizer, on the FDA approval of Hympavzi; the first non-factor and once-weekly treatment for Hemophilia B.
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Biocom California
For over 29 years, Biocom California has helped move the life science industry forward with transformative resources that enable companies to make meaningful connections. With a membership base of over {{{dynamic_content_1600}}} companies, we connect our members to each other so they can collaborate and work stronger and smarter together. We connect organizations to capital investment and purchasing solutions so they can grow faster and work more efficiently. We’re their link to advocacy that fights for innovation and we provide an environment where their business and talent can thrive. Biocom California is how the life science industry gets connected.
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