Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA diagnostics guidance

This article was originally published in The Gray Sheet

Executive Summary

Agency issues guidance on statistically appropriate practices for reporting qualitative results from studies to assess diagnostic tests. The March 13 document, "Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests," makes recommendations for submitting 510(k)s and PMAs for diagnostics. The guidance covers results from different types of studies and describes best practices for data collection and analysis. The guidance also outlines common inappropriate practices, focusing special attention on discrepant resolution and its associated problems. The agency received 11 comments on the 2003 draft version (1"The Gray Sheet" March 17, 2003, p. 11)...

You may also be interested in...



New FDA Policy On Diagnostics Studies “Fills A Big Gap,” CDRH Chief Says

Companies specializing in diagnostic products should pay close attention to a new, statistics-focused guidance document from FDA, device center Director Dan Schultz says

IVD Study Designs Warrant Consultation With CDRH Staff – Draft Guidance

Discrepant resolution alone is an inadequate method for reliably estimating the value of a new diagnostic test in relation to an imperfect standard, an FDA draft guidance states

Could Revisiting US Approval Decisions Become Less Rare?

While not identifying specific situations raising potential questions, the FDA commissioner uses his appearance at agency's annual rare disease event to advise regulatory decisions may be revisited as more data becomes available. 
UsernamePublicRestriction

Register

MT024592

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel