FDA Regulation definition

FDA Regulation means any rule, regulation or administrative order promulgated or issued by the FDA.
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FDA Regulation has the meaning ascribed to such term in Section 3.6.5.
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Examples of FDA Regulation in a sentence

  • The Complaint Report shall include, as applicable, an initial assessment of Medical Device Reporting (“MDR”) status (as required by the U.S. Food and Drug Administration (FDA) Regulation 21 CFR Part 803) or need for Vigilance reporting (“Vigilance”) as required by the European Union In Vitro Diagnostic Directive (“IVDD”) or the Canadian Medical Device Regulations (“CMDR”).

  • In addition, any trailer hauling mammalian protein products must be reported to the BROKER prior to loading and strict compliance of FDA Regulation 21 CFR Part 589.2000 is required.

  • Prior to initiation of the Study, Principal Investigator will obtain approval for the Protocol from its IRB, EC or similar committee formally designated by the Study Site to review biomedical research, in conformance with U.S. FDA Regulation 21 CFR Part 56 and applicable local regulations.

  • Full Com- mittee, hearing entitled ‘‘Check Up: Examining FDA Regulation of Drugs, Biologics, and Devices’’, 10 a.m., 2318 ▇▇▇▇▇▇▇.

  • Subcommittee on Health, hearing entitled ‘‘Check Up: Examining FDA Regulation of Drugs, Biologics, and De- vices’’, 10:30 a.m., 2322 ▇▇▇▇▇▇▇.

  • No event has occurred and to Seller’s Knowledge no circumstances exists, and no member of the Seller Group has received notice alleging any circumstance or condition that (with or without the passage of time or the giving of notice) may result in a violation of, conflict with or failure to conduct the Business in compliance with, any applicable Law, FDA Regulation, FDA Authorizations and ISO Requirements.

  • Distributor hereby agrees to establish and maintain a tracking system in compliance with the Safe Medical Device Act and the FDA Regulation (21 CFR 821) as amended to enable the Products to be promptly located within commercial distribution.

  • Study Site and Principal Investigator shall ensure that each patient enrolling in the Study gives his/her informed consent to such participation in accordance with the Study Site’s informed consent policies, and in conformance with U.S. FDA Regulation 21 CFR Part 50 and European Directive 2001/20/EC.