美国FDA 指导原则 设备建立检验流程和标准_1 英文原版.pdfVIP

Contains Nonbinding Recommendations Review and Update of Device Establishment Inspection Processes and Standards Guidance for Industry Document issued on June 29, 2020. The draft of this document was issued on March 29, 2019. For questions about this document contact the Office of Regulatory Affairs (ORA) Office of Strategic Planning and Operational Policy (OSPOP) at ORAPolicyStaffs@. U.S. Department of Health and Human Services Food and Drug Administration Office of Regulatory Affairs Center for Devices and Radiological Health Center for Biologics Evaluation and Research Contains Nonbinding Recommendations Preface Public Comment You may submit electronic comments and suggestions at any time for Agency consideration to . Submit written comments to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. Identify all comments with the docket number FDA-2019-D-0914. Comments may not be acted upon by the Agency until the document is next revised or updated. Additional Copies ORA Additional copies are available from the Internet. You may also send an e-mail request to ORAPolicyStaffs@ to receive a copy of the guidance. CDRH Additional copies from the Center for Devices and Radiological Health (CDRH) are available from the Internet. You may also send an e-mail request to CDRH-Guidance@ to receive a copy of the guidance. CBER Additional copies are available from the Center for Biologics Evaluation and Research (CBER) by written request, Office of Communication, Outreach and Developm