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Bookmark or Share- Roche granted FDA Breakthrough Device Designation for pTau217 blood ...Roche announced today that its Elecsys pTau217 assay received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).
- What Is an FDA Breakthrough Therapy Designation?The breakthrough therapy designation is one of the FDA's expedited programs aimed at accelerating the development and review of drugs and biologics for serious conditions. For treatments targeting serious or life-threatening conditions, time is of the essence. The FDA's breakthrough therapy designation offers a pathway to expedite the ...
- Breakthrough Device Designation Requests - National Institutes of HealthA Breakthrough Device Designation (BDD) request is a stand-alone request to FDA; it cannot be combined with any other requests such as a pre-submission meeting. FDA will issue a grant or denial decision for each BDD request within 60 calendar days of receipt.
- Breakthrough Devices Program | FDAThe Breakthrough Devices Program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for...
- Breakthrough Devices Program | FDAThe Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of...
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