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1. Emergency use authorization of medical products and related authorities: guidance for industry and other stakeholders

nlm:nlmuid-101712946-pdf

2. Form FDA 3674--certifications to accompany drug, biological product, and device applications/submissions: guidance for sponsors, industry, researchers, investigators, and food and drug administration staff

nlm:nlmuid-101712948-pdf

4. Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101713224-pdf

6. Design considerations and pre-market submission recommendations for interoperable medical devices: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101713256-pdf

7. Evaluation and reporting of age-, race-, and ethnicity-specific data in medical device clinical studies: guidance for Industry and Food and Drug Administration staff

nlm:nlmuid-101713258-pdf

8. Establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of human papillomaviruses: guidance for Industry and Food and Drug Administration staff

nlm:nlmuid-101713268-pdf

9. Drug and device manufacturer communications with payors, formulary committees, and similar entities: questions and answers : guidance for industry and review staff

nlm:nlmuid-101734304-pdf

10. Logical observation identifiers names and codes for in vitro diagnostic tests: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101734317-pdf

12. FDA categorization of investigational device exemption (IDE) devices to assist the Centers for Medicare and Medicaid Services (CMS) with coverage decisions: guidance for sponsors, clinical investigators, industry, institutional review boards, and Food and Drug Administration staff

nlm:nlmuid-101719990-pdf

13. Technical considerations for additive manufactured medical devices: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101720001-pdf