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Breakthrough Devices Program | FDA
- https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program
- As of June 30, 2022, CDRH and CBER have granted 693 Breakthrough Device designations, including devices originally designated under the Expedited Access Pathway (EAP) program. The following...
Expedited Review Process - Hopkins Medicine
- https://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/expedited_review.html
- (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for …
Frequently Asked Questions About Medical Devices
- https://www.fda.gov/files/about%20fda/published/Frequently-Asked-Questions-About-Medical-Devices---Information-Sheet.pdf
- Examples of medical devices include surgical lasers, wheelchairs, sutures, pacemakers, vascular grafts, intraocular lenses, and orthopedic pins. A longer list of examples of …
IRB Review of Medical Device Research - Emory …
- https://irb.emory.edu/_includes/documents/sections/guidance-irb-review-of-medical-device-research.pdf
- Note: Expedited Category 1 should not be used for studies that involve use of a device only, (no testing or data collected on or about the device), as FDA regulations …
Fast Track, Breakthrough Therapy, Accelerated …
- https://www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review
- A process designed to expedite the development and review of drugs which may demonstrate substantial improvement over available therapy. Breakthrough Therapy …
PMA Review Process | FDA - U.S. Food and Drug …
- https://www.fda.gov/medical-devices/premarket-approval-pma/pma-review-process
- The review of a premarket approval application (PMA) is a four-step review process consisting of: administrative and limited scientific review by FDA staff to …
Medical Device Reporting (MDR): How to Report Medical …
- https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems
- Submitting Medical Device Reports for Devices Licensed as Biological Products While most medical devices subject to the FDA's oversight are regulated by the Center for …
OHRP Expedited Review Categories (1998) | HHS.gov
- https://www.hhs.gov/ohrp/regulations-and-policy/guidance/categories-of-research-expedited-review-procedure-1998/index.html
- The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil …
Expert Review of Medical Devices: Vol 20, No 1 (Current …
- https://www.tandfonline.com/toc/ierd20/current
- Review Advances in additive manufacturing processes and their use for the fabrication of lower limb prosthetic devices Shaurya Bhatt, Deepak Joshi, Pawan Kumar Rakesh & Anoop Kant Godiyal Pages: 17 …
Expedited Review Procedures Guidance (2003) | HHS.gov
- https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-expedited-review-procedures/index.html
- Under an expedited review procedure, the IRB Chairperson, or one or more experienced reviewers designated by the Chairperson from among the members of the IRB, reviews …
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