![]() If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. ![]() If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests Benchmark and Study Population Recommendationsħ.1 Calculating Estimates of Sensitivity and Specificityħ.3 An Example of Discrepant Resolution and its Associated Problems.Please use the document number (1620) to identify the guidance you are requesting. You may also send an e-mail request to to receive a copy of the guidance. Additional CopiesĪdditional copies are available from the Internet. Comments may not be acted upon by the Agency until the document is next revised or updated. ![]() When submitting comments, please refer to Docket No. Alternatively, electronic comments may be submitted to. Written comments and suggestions may be submitted at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. The draft of this document was issued on March 12, 2003.įor questions regarding this document, contact Kristen Meier at 30, or send an e-mail to Department of Health and Human ServicesĬontains Nonbinding Recommendations Preface Public Comment Center for Devices and Radiological Health ![]()
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