of new products, which include vaccines and blood- and tissue-derived products.
The process for obtaining FDA approval for devices is entirely different from the process for obtaining approval for drugs, and the standards for proving safety and efficacy are also different. All medical devices must be manufactured under a quality assurance program, be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA. The manufacturers of only some classes of devices, however, must provide clinical data showing safety and efficacy.
Under Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act, Congress directed AHRQ to conduct and support research focused on patient outcomes; comparative clinical effectiveness; and the appropriateness of specific pharmaceuticals, devices, and health services. This AHRQ project, known as the Effective Health Care Program, incorporates three approaches as part of its work on comparative effectiveness: (1) knowledge synthesis through the EPCs (see below); (2) the generation of new knowledge through a network of research-based health care organizations with access to electronic health information databases and the capacity to conduct rapid-turnaround research; and (3) the translation of the research work into patient-oriented materials, conducted through the John M. Eisenberg Clinical Decisions and Communications Science Center (AHRQ, 2007b). Congress has appropriated $15 million annually for this effort.
Public and private organizations, such as AHRQ’s EPCs, the Blue Cross and Blue Shield Association (BCBSA) Technology Evaluation Center (TEC), the Cochrane Collaboration, the ECRI Institute, and Hayes, Inc., conduct syntheses of the available evidence (Table 2-1). These organizations provide systematic reviews, meta-analyses, and technology assessments that synthesize the available literature and describe what is known about the effectiveness of specific clinical interventions.
Individuals and organizations use the syntheses of the available evidence that these organizations produce in a number of ways. Public and private health plans use the information to inform their coverage decisions, professional and patient care organizations use the information to create practice guidelines, organizations that track provider performance rely on it to establish benchmarks of appropriate care, and the information is also