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HHS Guidance Documents
Title OpDiv/StaffDiv Sort descending Guidance Status Issue Date
Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board: Process for Referrals to Food and Drug Administration and Office for Human Research Protections: Draft Guidance for Institutional Review Boards,…  Food and Drug Administration (FDA) Proposed
Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs  Food and Drug Administration (FDA) Final
Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs  Food and Drug Administration (FDA) Final
Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions: Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Considerations When Transferring Clinical Investigation Oversight to Another IRB: Guidance for IRBs, Clinical Investigators, and Sponsors  Food and Drug Administration (FDA) Final
FDA Inspections of Clinical Investigators: Guidance For IRBs, Clinical Investigators, and Sponsors  Food and Drug Administration (FDA) Final
FDA Institutional Review Board Inspections: Guidance For IRBs, Clinical Investigators, and Sponsors  Food and Drug Administration (FDA) Final
Frequently Asked Questions About Medical Devices: Guidance For IRBs, Clinical Investigators, and Sponsors  Food and Drug Administration (FDA) Final
Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors  Food and Drug Administration (FDA) Final
IRB Continuing Review After Clinical Investigation Approval: Guidance for IRBs, Clinical Investigators, and Sponsors  Food and Drug Administration (FDA) Final
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