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Zdrowie i gospodarka · 12.08.2011

Mobile Medical Applications Draft Guidance; Public Workshop

The Food and Drug Administration (FDA) is announcing a public workshop entitled: "Mobile Medical Applications Draft Guidance." The purpose of the workshop is to provide a forum for discussion with FDA and to encourage public comment on the following topics: FDA's recently issued draft guidance document entitled "Mobile Medical Applications," how FDA should approach accessories and particularly mobile medical applications that are accessories to other medical devices, and standalone software that provides clinical decision support. Date and Time: The public workshop will be held on September 12 and 13, 2011. Submit electronic and written comments by October 19, 2011. Location: The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002. Contact Person: Bakul Patel, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5456, Silver Spring, MD 20993, 301-796-5528, [email protected]. Registration and Requests for Oral Presentations: Registration is free and will be on a first-come, first-served basis. Person

Source: Federal Register — Health and Human ServicesOpen original release →