WebCDRH has reorganized to support a Total Product Life Cycle (TPLC) approach CDRH Office of Communication . ... Introducing our new OIR/OHT7 Deputy and Associate Directors. Dr. Wendy Rubinstein, MD, PhD. ... • FDA remains concerned about troponin laboratory tests that have not addressed the risk of biotin WebApr 4, 2024 · Tamie Pate. 240-402-8676. Assistant Director for Space and Facilities Management. Stephanie Hawk. 301-796-4113. Assistant Director for Committee Management and Planning. CDR Daniel Bailey. 301-796-2452. Division of …
How can I find out if my product is regulated by CDRH? FDA
WebJan 4, 2024 · The CDRH Office of In Vitro Diagnostics and Radiological Health (within the Office of Product Evaluation and Quality, or OPEQ) is known as OIR or OHT7. Under the … WebU.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20903 www.fda.gov March 22, 2024 . David McGrath . Vice President, Regulatory and Clinical Affairs michael o\u0027leary actor
OHT7: Office of In Vitro Diagnostics, Office of Product …
The Office of Health Technology 7: Office of In Vitro Diagnostics within CDRH's Office of Product Evaluation and Quality (OPEQ)is … See more For specific phone numbers and email addresses for each office, see the CDRH Management Directory by Organization. For general questions about medical devices regulation, … See more For in vitro diagnostics medical devices, we: 1. Implement a TPLC model for the office's medical device product area. The TPLC model includes implementation of premarket review programs (e.g., 510(k), PMA, HDE, DeNovo, … See more WebFeb 6, 2024 · Biologist at FDA/CDRH/OPEQ/OHT7/DMGP/MPCB White Oak, Maryland, United States 119 followers 117 connections Join to connect FDA/CDRH/OPEQ/OHT7/DMGP/MPCB About Health science professional... WebFDA Update CLIAC April 12, 2024 Timothy Stenzel, M.D., Ph.D. Director, Office of In Vitro Diagnostics (OHT7 –Office of Health Technology 7) Office of Product Evaluation and Quality (OPEQ) ... 2024 through 2027 •CDRH is accepting and immediately initiating the review process for all new IVD premarket submissions and pre-submissions in ... michael o\u0027keefe stifel