Medical Devices Required Posting To Clinicaltrials.Gov

FDAAA 801 and the Final Rule - ClinicalTrials.gov

https://clinicaltrials.gov/ct2/manage-recs/fdaaa

Pediatric Postmarket Surveillances of Device Products. Pediatric postmarket surveillances of device products ordered under Section 522 of the FD&C Act (PDF) as amended by Section 307 of FDAAA are considered ACTs and must be registered on ClinicalTrials.gov …

Frequently Asked Questions - ClinicalTrials.gov

https://clinicaltrials.gov/ct2/manage-recs/faq

Why Should I Register and Submit Results?

https://clinicaltrials.gov/ct2/manage-recs/background

Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) …

Registering with ClinicalTrials.gov | Guidance Portal

https://www.hhs.gov/guidance/document/registering-clinicaltrialsgov

Clinical trial sponsors are required to register and report results for certain clinical trials of drugs, biologics, and devices that are subject to FDA regulations. …

How to Register Your Study - ClinicalTrials.gov

https://clinicaltrials.gov/ct2/manage-recs/how-register

Required Registration Updates. Responsible Parties should update their records within 30 days of a change to any of the following: Individual Site Status and Overall Recruitment …

FDA's Role: ClinicalTrials.gov Information | FDA - U.S.

https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/fdas-role-clinicaltrialsgov-information

To certify compliance with ClinicalTrials.gov requirements, FDA requires that applicants complete and submit Form FDA 3674 with certain human drug, biological …

FDA Takes Action For Failure to Submit Required …

https://www.fda.gov/news-events/press-announcements/fda-takes-action-failure-submit-required-clinical-trial-results-information-clinicaltrialsgov

The submission to and posting of clinical trial information on ClinicalTrials.gov honors volunteers who participate in research to advance medical science and enhances public …

Support Materials - ClinicalTrials.gov

https://clinicaltrials.gov/ct2/manage-recs/resources

Revised Common Rule (45 CFR Part 46) and Posting of Clinical Trial Consent Forms. A revised Federal Policy for the Protection of Human Subjects (also known as subpart A of …

ClinicalTrials.gov – What, Why, Which Studies, When

https://www.bumc.bu.edu/ohra/clinicaltrials-gov/clinicaltrials-gov-what-why-which-studies-when/

Other Relevant Definitions (from BMC Registering, Updating and Posting on ClinicalTrials.gov (09_24_000 Rev Sep 2019): Applicable Clinical Trial (ACT): …

ClinicalTrials.gov Registration & Reporting Requirements

https://research.oregonstate.edu/irb/clinicaltrialsgov-registration-reporting-requirements

In a Nutshell. Studies must be registered with ClinicalTrials.gov if: they involve drugs, devices, or biologics that are regulated by the Food and Drug Administration (FDA), OR; …