Medtech Insight is part of the Business Intelligence Division 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


Firms Must Submit The Good, Bad, And Ugly Trial Data On Devices Under Clinical Trials Rule

Executive Summary

Device firms will have to submit a lot more clinical trials outcomes data to the portal – including for products that have not been cleared, approved, or launched – based on a final rule recently issued by HHS. Even though sponsors can delay reporting two years, the rule expands the volume of reports that will find their way to the public-facing, clinical trials website, and the change could have downsides, attorneys say.


Related Content

HHS ClinicalTrials.Gov Rule Details Penalties For Failure To Submit
FDA Drafts Plan To Publicize 'Emerging Signals' Of Device Risks





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