- Data inadequacies undermine CMS's oversight of the inconsistency resolution process for the federal marketplace1
- De novo classification process (evaluation of automatic class III designation): guidance for industry and Food and Drug Administration staff1
- Deciding when to submit a 510(k) for a change to an existing device: guidance for Industry and Food and Drug Administration staff1
- Deciding when to submit a 510(k) for a software change to an existing device: guidance for industry and Food and Drug Administration staff1
- Defense civil support: DOD, HHS, and DHS should use existing coordination mechanisms to improve their pandemic preparedness : report to the Committee on Armed Services, House of Representatives1
- Design considerations and pre-market submission recommendations for interoperable medical devices: guidance for industry and Food and Drug Administration staff1
- Developing and responding to deficiencies in accordance with the least burdensome provisions: guidance for industry and Food and Drug Administration staff1
- Display devices for diagnostic radiology: guidance for industry and Food and Drug Administration staff1
- Drug supply chain security: wholesalers exchange most tracing information1
- Drug-free community support program: agencies have strengthened collaboration but could enhance grantee compliance and performance monitoring : report to Congressional committees1
- E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3)1
- Early learning and child care: agencies have helped address fragmentation and overlap through improved coordination : report to the Chairwoman, Committee on Education and the Workforce, House of Representatives1
- Early learning and child care: overview of federal investment and agency coordination : testimony before the Subcommittee on Early Childhood, Elementary, and Secondary Education, Committee on Education and the Workforce, House of Representatives1
- Emergency use authorization of medical products and related authorities: guidance for industry and other stakeholders1
- Enhancements needed in the tracking and collection of Medicare overpayments identified by ZPICS and PSCS1
- 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 staff1
- Evaluating drug effects on the ability to operate a motor vehicle1
- Evaluation and reporting of age-, race-, and ethnicity-specific data in medical device clinical studies: guidance for Industry and Food and Drug Administration staff1
- Excluding noncovered versions when setting payment for two Part B drugs would have resulted in lower drug costs for Medicare and its beneficiaries1
- 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 staff1