The FDA issued a final rule, effective Feb. 21, 2019, to revise regulations about accepting data from clinical studies involving medical devices.1

The rule, titled, “Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices,” updates FDA’s standards for accepting clinical data from investigations in the United States and internationally.

Comments about the proposed rule suggested the rule should not be finalized until there are established harmonized international good clinical practice (GCP) guidelines for medical devices. The FDA’s response was there already is a GCP standard for medical devices, called the “Clinical Investigation of Medical Devices for Human Subjects — Good Clinical Practice.”

Sponsors and applicants under the new rule must provide information about how their investigations conform with GCP. These include clinical data, supporting investigational device exemptions, premarket notifications, requests for De Novo classification, premarket approvals, product development protocols, and humanitarian device exemptions.

According to the published final rule, “FDA believes the requirements outlined in the rule allow the flexibility needed to accommodate the laws and regulations of other countries. We also believe that conducting a clinical investigation according to a standard that meets the definition of GCP as provided in the rule will help to ensure the integrity and quality of the data and the protection of subjects.”

The rule also allows sponsors and applicants to explain why GCP was not followed and to describe the steps they took to ensure that the data and results are credible and accurate and that the rights, safety, and well-being of human subjects have been adequately protected.

In general, the FDA agrees that data from clinical investigations that were not conducted in conformity with GCP may still provide useful information — even information that is relied upon to make regulatory decisions, the rule states.

“The intent of the rule is not to disallow the use of data from certain investigations, but rather to ensure FDA’s decisions are based on scientifically valid and ethically derived data,” according to the rule. “Conformance with GCP is one way to help ensure clinical data are credible, accurate, and ethically procured.”

For more information, contact the Division of Industry and Consumer Education in the Center for Devices and Radiological Health at 1-800-638-2014, 301-796-7100, or dice@fda.hhs.gov.

REFERENCE

1. Human subject protection; Acceptance of data from clinical investigations for medical devices. Fed Reg. Feb. 21, 2018. Available at: http://bit.ly/2t1KhIC.