移动医疗app开发商指南.pdf

Contains Nonbinding Recommendations Mobile Medical Applications __________________________ Guidance for Industry and Food and Drug Administration Staff Document issued on: September 25, 2013 The draft of this guidance was issued on July 21, 2011. For questions regarding this document, contact Bakul Patel at 301-796-5528 or by electronic mail at Bakul.Patel@ . For questions regarding this document concerning devices regulated by CBER, contact the Office of Communication, Outreach and Development (OCOD), by calling 1-800-835-4709 or 301-827-1800. U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research - 1 - Contains Nonbinding Recommendations Preface Public Comment You may submit written comments and suggestions at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061 (HFA-305), Rockville, MD, 20852. Submit electronic copies to . Identify all comments with the docket number listed in the notice of availability that publishes in Federal Register . Comments may not be acted upon by the Agency until the document is next revised or updated. Additional Copies CDRH Additional copies are available from the Internet. You may also send an e-mail request to dsmica@ to receive an electronic copy of the guidance or send a fax request to 301- 847-8149 to receive a hard copy. Please use the document number (1741) to identify the guidance you are requesting. CBER Additional copies are available from the Center for Biolog