• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts & Webinars
    • Podcasts
    • Webinars
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
  • Coronavirus: Live updates
Home » HHS, FDA finalize reporting rules for ClinicalTrials.gov

HHS, FDA finalize reporting rules for ClinicalTrials.gov

September 16, 2016 By Fink Densford

FDA logo

The U.S. Department of Health and Human Services and the FDA today released a final rule on results-reporting requirements for ClinicalTrials.gov, expanding registration requirements and providing a defined timeline with requirements for reporting trial results.

The new rule provides clarity on statutory language, laying out objective, structure criteria for evaluating whether studies are “applicable clinical trials.”

The rule clarifies that multigroup and single-group interventional studies with “prespecified outcome measures” are considered “controlled,” and creates a distinction between “secondary” and other pre-specified outcome measures, according to a New England Journal of Medicine report.

The HHS and the FDA laid out rules that expanded transparency beyond the basic statutory requirements in the new rule, now requiring submission of result information for ACTs of unapproved products and submission of baseline information on race or ethnic groups, or other characteristics, associated with primary outcome measures.

Included in the rule are defined required levels of specifications for outcome measures, requirements that responsible parties submit information on adverse-event timeframes and collection methods and all-cause mortality and submission of full protocol and statistical analysis.

With the new rules, the NIH will post submitted records within a specified time frame, “even if the records do not meet quality-control criteria,” including a disclaimer and possible notation of the identified concerns. The NIH will also post registration information for trials of unapproved devices if authorized by a responsible party.

The HHS declined requiring submission of narrative summaries with the rule.

The groups said that the ClinicalTrials.gov data-entry system will be “ready to support all regulatory submission requirements by the rule’s effective date on January 18, 2017.” Groups using the system will have an additional 90 days after the launch to “come into compliance with the final rule,” according to the NEJM report.

Filed Under: Clinical Trials, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: U.S. Department of Health and Human Services

In case you missed it

  • Abbott imaging catheter recall flagged as Class I by FDA
  • Will Johnson & Johnson buy Boston Scientific?
  • Needham & Co. downgrades Medtronic, Zimmer Biomet shares
  • DoMore Diagnostics wins CE mark for AI algorithm that predicts colorectal cancer outcomes
  • Quidel, Ortho Clinical Diagnostics combine to form in vitro diagnostics company
  • Zimmer Biomet adds ESG and CEO visibility to executive’s duties
  • U of Maryland scientist to set up NIH’s new Advanced Research Projects Agency for Health
  • ‘Catastrophic explosion’ and resin shortage led Medtronic’s supply chain problems
  • FDA grants IDE for MedAlliance’s sirolimus-eluting balloon
  • Medtronic ‘hopeful’ on FDA clearance for next-gen diabetes tech in FY 2023
  • Bigfoot Biomedical adds former Insulet VP as chief commercial officer
  • Medtronic, DaVita to form new kidney care company
  • Medtronic stock down on Q4 earnings miss
  • 3M Health Care Business president is leaving this year
  • Device developer SeaStar Medical hires chief medical officer
  • AccuPulse raises $10M Series A
  • Exactech announces first U.S. surgeries with its nex-gen laser cage glenoid

RSS From Medical Design & Outsourcing

  • Download COMSOL News Special Edition Biomedical
    Get instant access to this special edition of COMSOL News where you will read user stories that showcases how simulation enables engineers, researchers, and scientists explore and analyze biomedical designs. Download Now.       The post Download COMSOL News Special Edition Biomedical appeared first on Medical Design and Outsourcing.
  • Qosina adds new tube-to-tube barb connectors
    Qosina has added 25 new tube-to-tube barb connectors to its portfolio, the OEM single-use component supplier for the medical and pharmaceutical industries said this week. Ronkonkoma, New York-based Qosina said its inventory of tube-to-tube barb connectors is available in more than 500 configurations. The connectors can fit inner tube diameters between 1/32 in and 1… […]
  • Abbott imaging catheter recall flagged as Class I by FDA
    The FDA has identified the Abbott (NYSE:ABT) recall of its Dragonfly OpStar Imaging Catheter as a Class I recall. That’s the most serious level of a medical device recall, carrying the risk of serious injury or death. Five incidents, one injury and zero deaths were reported when Abbott initiated the recall on April 11. The… […]
  • Zimmer Biomet adds ESG and CEO visibility to executive’s duties
    Zimmer Biomet (NYSE:ZBH) today announced additional responsibilities for Investor Relations SVP and Chief Communications Officer Keri Mattox. Mattox’s new title at the Warsaw, Indiana-based orthopedics company is chief communications and administration officer. She will be responsible for “building and executing a comprehensive strategy around Environmental, Social and Governance (ESG) initiatives and increasing CEO visibility, engagement… […]
  • ‘Catastrophic explosion’ and resin shortage led Medtronic’s supply chain problems
    Medtronic CEO Geoff Martha today said a “catastrophic explosion” in Medtronic’s supply chain for packaging and a shortage of resins were the biggest issues hurting the company’s fourth-quarter performance. Fridley, Minnesota-based Medtronic (NYSE:MDT) reported about $350 million less in sales than analysts were expecting for the quarter, which ended April 29. Martha said about 75%… […]
  • 3M Health Care Business president is leaving this year
    3M Health Care Business Group President Mojdeh Poul will retire from the company on July 1, 2022. Poul joined Maplewood, Minnesota-based 3M (NYSE:MMM) in 2011 as the global business VP of critical and chronic care solutions. She later became VP and general manager of the company’s food safety business and president of numerous 3M divisions,… […]
  • Iterative Scopes announces positive data in Skout AI colonoscopy algorithm clinical trial
    Iterative Scopes this week announced positive trial data in a study of its colorectal cancer screening algorithm, Skout. Cambridge, Massachusetts-based Iterative Scopes designed Skout as a computer-aided device (CADe) that uses artificial intelligence and computer vision technology to detect suspicious tissue and provide real-time feedback for gastroenterologists performing the procedure. Get the full story on… […]
  • Device developer SeaStar Medical hires chief medical officer
    SeaStar Medical has hired Dr. Kevin Chung as chief medical officer of the medtech developer starting July 1. Denver-based SeaStar is developing a platform therapy focused on hyperinflammation of vital organs. The company’s Selective Cytopheretic Device was designated as a breakthrough device by the FDA earlier this year. SeaStar is set to go public in… […]
  • Varta presents microbattery product portfolio at Computex 2022
    Varta will present its broad product portfolio of microbatteries, which make a wide range of future-proof applications possible, at Computex in Taipei starting today. Varta’s microbattery product portfolio ranges from rechargeable lithium-ion button cells to nickel metal hydride button cells, primary silver oxide cells, primary lithium button cells and cylindrical lithium batteries to hydrogen gas… […]
  • Entegris opens Life Sciences Technology Center in Massachusetts
    Entegris (Nasdaq:ENTG) announced today that it opened a new Life Sciences Technology Center in Billerica, Massachusetts. The new Life Sciences Technology Center was built to offer life sciences customers the opportunity to leverage Entegris’ cold-chain supply expertise to optimize processes, reduce costs and increase speed to market. Get the full story at our sister site,… […]
  • MedAcuity hires SVP of business development
    Medtech software development firm MedAcuity today said it has hired Simon Johnson as SVP of business development. Westford, Massachusetts-based MedAcuity said Johnson previously built the client partner team and managed strategic clients at digital consultancy Mobiquity. He also served as SVP of client services at GreenPages Technologies, responsible for driving services revenue growth leading to… […]

Primary Sidebar

DeviceTalks Weekly

May 27, 2022
Quick message - No DTW podcast, but plenty else to listen to over this weekend and next week.
See More >

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World

Device Talks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our Device Talks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us
Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS