Zdrowie i gospodarka · 17/09/1999

Development of Guidance Documents for Medical Devices Regulated by the Center for Biologics Evaluation and Research; Stakeholders Input Under FDA Modernization Act of 1997; Public Meeting and Teleconference

The Food and Drug Administration (FDA) is announcing a public meeting and teleconference entitled ``Development of Guidance Documents for Medical Devices Regulated by the Center for Biologics Evaluation and Research-Stakeholders Input Under FDA Modernization Act of 1997.'' The goals of the public meeting and teleconference are to explain to stakeholders the process and development of medical device guidance documents under good guidance practices (GGP's) and how to participate in both processes and to give stakeholders the opportunity to provide input on what they think the Center for Biologics Evaluation and Research's (CBER's) priorities should be regarding medical devices regulated by CBER. The agency is also requesting comments prior to the meeting, from stakeholders on proposals of priorities for development of guidance documents related to CBER-regulated medical devices.