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# CDRH Role in Device Trial Design Should be Disclosed: JAMA
- URL: https://www.fdaweb.com/cdrh-role-in-device-trial-design-should-be-disclosed-jama/
- Published: 2017-11-07T12:00:00.000Z
- Updated: 2026-09-14T23:00:21.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140077

Medical journal editors should encourage authors to disclose CDRH’s role in clinical trial design and execution and to discuss pivotal trial results within the context of regulatory approval, according to an 11/7 *JAMA* [viewpoint](https://jamanetwork.com/journals/jamacardiology/article-abstract/2660061?ref=fdaweb.com) piece. “Such policies will increase transparency and understanding of the regulatory approval process and facilitate more open and better informed discussions around the subsequent clinical adoption of new medical technologies,” write authors **Aaron V. Kaplan** (Dartmouth-Hitchcock Medical Center’s Heart & Vascular Center) and **Ariel D. Stern** (Harvard Business School).

Results from pivotal trials that evaluate new, high-risk devices are routinely published in leading, peer-reviewed medical journals, which are often the core source for clinicians to determine whether a new therapy should be adopted in their clinical practice. Consistent disclosure of CDRH's role in designing and executing pivotal trials should be required because it improves transparency and provides “a clear signal that a study was conducted to a regulatory standard, which in many ways exceeds the already high standards that are required for publication in top-tier, peer-reviewed journals,” according to the authors. Also, discussing the “context and intent to evaluate a specific device for regulatory approval allows for a better understanding of the study and facilitates a more nuanced understanding of the regulatory approval process for practitioners,” they write.

CDRH must “balance patient risk against pressure from the health care industry, clinicians, and patients who demand faster access to new technology,” the authors say. “Finding balance in medical device regulatory policy is an important public health issue that demands an informed public debate. Central to this debate is an understanding of the role of FDA/CDRH in this process and the regulatory science of new high-risk device approvals.”