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Guidance on IRB Continuing Review of Research. General Considerations; Determining the First Continuing Review Date for Research Reviewed by operating the IRB (45 CFR 46.103(a) and 46.103(b)(2)); also see the Terms of the FWA at .. K. Identifying the Point When Continuing Review is no Longer Necessary.

26 Jun 2014 or after June 1, 2014. Prior to the effective date of the amendments, those audits were . Page 2. Performing the Review Engagement. 60. Evaluating the Results of the Review Procedures. 65 75. Appendix C: Exemption Provisions in SEC Rule15c3-3(k). 92 17 and paragraph B2 of Auditing. Standard 

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In effect, manufacturers need to submit a new 510(k) only when a and special controls in the 510(k) review, as well as ways to better . Documentation must include the change approval date and the . This is also true for changes in operating principle (decision point B2) as well