News | Cardiovascular Business | February 21, 2018

FDA Releases Final Rule on Data Acceptance from Medical Device Clinical Investigations

Final rule updates regulations on acceptance of data from trials conducted outside the U.S.

FDA Releases Final Rule on Data Acceptance from Medical Device Clinical Investigations

February 21, 2018 — The U.S. Food and Drug Administration (FDA) issued the final rule on “Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices.” The rule updates the FDA’s standards for accepting clinical data from clinical investigations conducted both inside and outside the United States to help ensure the protection of human participants, and to help ensure the quality and integrity of data obtained from these clinical investigations.

The final rule amends FDA regulations on acceptance of data from clinical investigations conducted outside the United States to reflect the increasing globalization of clinical trials and the evolution of clinical trial standards for protecting human subjects. The new rule requires that sponsors and applicants provide statements and information about how the investigations conform with good clinical practices (GCP). This applies to clinical data submitted to support investigational device exemptions (IDE), premarket notifications (510(k)), requests for De Novo classification, premarket approvals (PMA), product development protocols (PDP) and humanitarian device exemptions (HDE). The FDA believes that the requirements set out in the final rule provide flexibility for medical device sponsors conducting multinational clinical trials by allowing them to describe the standard for good clinical practice they followed.

The final rule also amends the IDE, 510(k) and HDE regulations for FDA acceptance of data from clinical investigations conducted within the United States to require a statement regarding compliance with FDA regulations for human subject protection, institutional review boards, and IDEs. This change is intended to provide consistency across different submission or application types.

The FDA also published the guidance document “Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions” on the same date. The guidance document is in question and answer format, and provides clarifications and recommendations to help stakeholders ensure that studies conducted in the U.S. or foreign countries comply with the new rule and revised regulations.

For more information: www.fda.gov

 

Related Content

CMS Proposes Overhaul of Medicare's Accountable Care Organization Program
News | Cardiovascular Business | August 09, 2018
The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule August 9 that would overhaul the Medicare...
ECRI Institute Announces New Clinical Guideline Repository Website
News | Cardiovascular Business | July 27, 2018
July 27, 2018 — Following the deactivation of the National Guideline Clearinghouse (NGC) by the Agency for Healthcare
FDA Releases New Report Assessing Quality, Safety and Effectiveness of Medical Device Servicing
News | Cardiovascular Business | June 07, 2018
A new report from the U.S. Food and Drug Administration (FDA) discusses the continued quality, safety and effectiveness...
DAIC Editor Dave Fornell won the 2018 AZBEE national silver award for best blog for "The Future of Cardiology: 17 Technologies to Watch. DAIC magazine - diagnostic and interventional cardiology magazine.
News | Cardiovascular Business | May 14, 2018
May 14, 2018 — Diagnostic and Interventional Cardiology (DAIC) magazine was honored with a ...
FDA Announces New Medical Device Safety Action Plan
News | Cardiovascular Business | April 25, 2018
The U.S. Food and Drug Administration (FDA) released a new Medical Device Safety Action Plan outlining how the agency...
DAIC Wins Two 2018 Regional Azbee Awards for Editorial Excellence
Feature | Cardiovascular Business | April 20, 2018
Diagnostic and Interventional Cardiology was honored with a pair of Azbee Awards for editorial excellence at the 2018...
DAIC Editor Dave Fornell displays the 2018 Neal Award for Best Use of Social Media
News | Cardiovascular Business | April 05, 2018
April 5, 2018 — Diagnostic and Interventional Cardiology (DAIC) magazine received the 2018 Jesse H.
Veritas Capital Acquiring Three Software Units from GE Healthcare
News | Cardiovascular Business | April 02, 2018
GE Healthcare announced the sale of its Value-Based Care Division — including its software assets for Enterprise...
The annual Azbee Awards are hosted by the American Society of Business Publication Editors (ASBPE) to recognize editorial and design excellence in the business, trade and specialty press. Dave Fornell won blog award for DAIC
News | Cardiovascular Business | March 08, 2018
Scranton Gillette Communications’ Diagnostic and Interventional Cardiology (DAIC) was recently named a 2018
Fysicon announced its acquisition by Canon Medical Systems Corporation.
News | Cardiovascular Business | March 08, 2018
Fysicon announced its acquisition by Canon Medical Systems Corporation. Linda Elberse, CEO of Fysicon, stated: "Being...
Overlay Init