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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Design Considerations for Pivotal Clinical Investigations for Medical Devices: Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA Staff  Food and Drug Administration (FDA) Final
Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program: Guidance for Industry, Clinical Laboratories, and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
The Meaning of "Spouse" and "Family" in FDA's Regulations after the Supreme Court's Ruling in United States v. Windsor: Questions and Answers: Guidance for Industry, Consumers, and FDA Staff  Food and Drug Administration (FDA) Final
Remanufacturing of Medical Devices: Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Decorative, Non-corrective Contact Lenses: Guidance for Industry, FDA Staff, Eye Care Professionals, and Consumers  Food and Drug Administration (FDA) Final
Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors - Three Additional Questions: Guidance for Industry, FDA Staff, Third-Party and Hospital Reprocessors  Food and Drug Administration (FDA) Final
Medical Device User Fee Small Business Qualification and Certification: Guidance for Industry, Food and Drug Administration Staff and Foreign Governments  Food and Drug Administration (FDA) Final
Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle: Draft Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties  Food and Drug Administration (FDA) Proposed
Patient Engagement in the Design and Conduct of Medical Device Clinical Studies: Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders  Food and Drug Administration (FDA) Final
Patient Preference Information - Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling: Guidance for Industry, Food and…  Food and Drug Administration (FDA) Final
This Guidance Portal contains 3340 documents.

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