Medical devices; implementation of third party review under the Food and Drug Administration Modernization Act of 1997; emergency processing request under OMB review--FDA. Notice.
The Food and Drug Administration (FDA) is announcing a program under which persons may be accredited to review premarket notifications and recommend initial classification of certain medical devices. At the same time, FDA is announcing the termination of the Third Party Review Pilot Program. This notice announces the criteria to accredit or deny accreditation to persons (Accredited Persons) who request to conduct premarket notification reviews consistent with provisions of the FDA Modernization Act of 1997 (FDAMA). FDA is also announcing that this proposed collection of information has been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995 (the PRA). FDA is requesting OMB approval within 45 days of receipt of this submission. FDA is taking this action to implement section 210 of FDAMA. The availability of guidance detailing the review of submissions, training for third party reviewers, and basic document processing by FDA is announced elsewhere in this tissue of the Federal Register.
D000068:Accreditation / Q000331:legislation & jurisprudence*; D003284:Contract Services / Q000331:legislation & jurisprudence / Q000592:standards; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004864:Equipment and Supplies / Q000145:classification; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration*