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# Require High-Quality Device Evidence: Blog
- URL: https://www.fdaweb.com/require-high-quality-device-evidence-blog/
- Published: 2018-10-11T12:00:00.000Z
- Updated: 2026-09-15T00:37:45.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142567

FDA should require high-quality evidence that meaningful clinical benefits exceed risks for medical devices. That’s the conclusion of a *Health Affairs* blog [post](https://www.healthaffairs.org/do/10.1377/hblog20181004.266389/full/?ref=fdaweb.com) by University of California San Francisco cardiologist **Rita Redberg** that explores lessons learned from the 2017 ORBITA study that found that coronary stenting did not improve exercise time when compared with a placebo procedure in patients with angina and severe arterial narrowing who received optimal medical therapy.

“Current lax FDA requirements for approval of high-risk devices mean that millions of Americans receive untested or inadequately studied risky devices,” Redberg says. “Coverage by public and private insurance of these untested devices often follows, and sometimes coincides with FDA approval, costing billions of dollars.”

The post explains that most medical devices enter the market without any evidence from clinical trials of benefits for patients. “Even the highest-risk devices, which go through the most stringent pathway, rarely have high-quality evidence to support their approval; they are not supported by even one blinded, randomized controlled trial (RCT) with meaningful clinical endpoints, much less the two RCTs we generally require for drug approval,” Redberg says. The author says the reason for the disparity between drug and medical device approvals is explained, at least in part, by the fact that medical devices were added to FDA’s regulatory authority late in the agency’s life (1976), and dealing with the many devices already on the market at that point was a particular challenge.

The post describes ORBITA as the first placebo-controlled trial of percutaneous coronary intervention, conducted more than 40 years after the procedure entered clinical practice. The trial was negative on the primary endpoint and eight of nine secondary endpoints. “I don’t know which is more disturbing,” Redberg writes, “that a procedure was used for 40 years without any placebo-controlled trial, or that even after an overwhelmingly negative placebo-controlled trial was done, there has been no change in guidelines or practice.”

She quotes former FDA commissioner **Robert Califf** as saying that the decision on whether placebo controls should be required for device approval was more of a decision for the clinical community. “The profession must demand higher standards for approval and use of devices and procedures,” she says, “especially as these carry risks of serious adverse events, including death. Professional society guidelines should reflect high-quality evidence and make clear when such evidence is lacking, for example in the cases of diabetes and cholesterol management….ORBITA shows the importance of placebo-controlled trials for devices and procedures before FDA approval and incorporation in professional society guidelines and clinical practice, as we expect for drugs. After FDA approval, use of new devices is often like bullet trains leaving the station. Patients deserve no less than high-quality data of net benefit before they consent to invasive and risky procedures. Regulatory and coverage processes should be consistent with this principle of evidence of benefit first, with continued data collection to help refine use.”