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


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

This article was originally published in The Gray Sheet

Executive Summary

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

You may also be interested in...

FDA diagnostics guidance

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)...

Atlas Biomed Unlocking Japan’s OTC Market With Direct-To-Consumer DNA And Microbiome Tests

Can Atlas Biomed unlock Japan's self-care market with its direct-to-consumer DNA and microbiome tests? HBW Insight catches up with the company's co-founder and CEO to discuss this and also how Atlas has been driving its European expansion plans despite coronavirus. 

Hair Supplement Linked To Cases Of Severe Hepatitis In France

France's ANSES warns women using oral contraceptives not to use a supplement marketed by UK firm Hairburst after linking the product's consumption to two cases of severe acute hepatitis.




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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