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# CDRH Officials Review Device Clinical Trial Considerations
- URL: https://www.fdaweb.com/cdrh-officials-review-device-clinical-trial-considerations/
- Published: 2017-04-07T12:00:00.000Z
- Updated: 2026-09-14T22:16:44.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138400

CDRH officials have provided their viewpoint on differing clinical trial considerations in producing data to justify marketing approval or clearance. Writing in a 6/6 *New England Journal of Medicine* r[eview article](http://www.nejm.org/doi/full/10.1056/NEJMra1512592?rss=searchAndBrowse&ref=fdaweb.com), CDRH director **Jeff Shuren** and Office of Device Evaluation clinical trials director **Owen Faris** acknowledge the shift to deferring certain confirmatory evidence to the post-marketing space. “Strategic investments and collaboration to establish a medical-device national evaluation system that are currently under way could improve the efficiency, timeliness, and comprehensiveness of postmarketing evidence generation,” they write. “Such partnerships on a national and an international level are needed to ensure that appropriate data collection continues throughout the life cycle of a medical device as part of a learning health care system so that patients and practitioners are fully informed as to how best to use these technologies to support improved patient health and quality of life.”

Shuren and Faris also discuss accepting data from registries or studies conducted abroad for devices that are already available in other geographic locations or for other indications. “Advancements in the science of patient input are also needed to help ensure that clinical trials are designed to assess what matters most to patients and to facilitate patient enrollment in studies,” they write. “In this spirit, we have been working with patient groups and other groups to foster the evaluation of patient preferences for benefits and acceptability of risks of devices for particular diseases to inform device-approval decisions. In the future, we see such data generation helping to inform the development of medical-device clinical trials and becoming a routine part of those trials.”

Patient registries and electronic health records offer great potential for addressing future premarketing and postmarketing questions, according to the CDRH officials. “For example, registry data have been used as historical controls and have also allowed the FDA to reduce or replace postapproval study requirements,” their article says. “Registry data may also serve as the basis for statistically derived objective performance criteria. Future devices may be compared with those criteria to show acceptable clinical performance, thereby eliminating the need for a control group.

  
“In the longer term,” they continue, “we expect to see randomized studies embedded within registries, leveraging that existing infrastructure and minimizing the burden for study start-up and execution. For example, a next-generation unapproved device that requires a clinical trial to support approval could be studied under a protocol designed to have its data requirements aligned with an existing registry that gathers high-quality outcomes data for approved devices of that type. Investigational sites already participating in the registry could leverage their experience and existing processes to easily participate in the premarketing trial. Such an approach could simplify data gathering, auditing, and analysis by relying on methods already in place for the registry.”