Five years ago, in February 2013, FDA issued a proposed rule to revise the regulations under which FDA will accept data from clinical studies as support for an IDE application, a 510(k) submission, a PMA application, a product development protocol application, or an humanitarian device exemption (“HDE”) application. FDA stated that the proposed rule reflected an effort to update the criteria for acceptance of data to ensure the quality and integrity of the data and the protection of human subjects. The proposed rule updated the criteria for acceptance of data from clinical studies conducted outside and inside the US. The proposed rule also identified a similar set of criteria for acceptance of clinical data for all application and submission types for medical devices.
After receiving and reviewing comments from the public, FDA issued a final rule and guidance on February 21, 2018, which addressed some concerns raised in the comments by altering the proposed rule and explaining FDA’s disagreements with others. The final rule further updates the criteria for FDA acceptance of data from clinical investigations conducted outside the US. In doing so, it also works to clarify several points of confusion in the proposed rule, such as clarifying that the final rule applies only to data from clinical “investigations” conducted outside of the US to support an IDE, for example, rather than to all clinical data in a submission. FDA also explained that it was amending the IDE, 510(k), and HDE regulations to address the requirements for FDA acceptance of data from clinical investigations conducted inside the US.
More specifically, the final rule requires that sponsors and applicants that include data from clinical investigations conducted outside the US to support an IDE application or premarket submission, for example, provide a statement of compliance and specific information regarding how the investigations conform to good clinical practice (“GCP”). The specific information required to show conformity with a GCP depends on whether the data is used in support of a significant or non-significant risk device. For purposes of this rule, FDA broadly defines GCP as “a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical investigations in a way that provides assurance that the data and results are credible and accurate and that the rights, safety, and well-being of subjects are protected.” Notably, GCP includes review and approval by an independent ethics committee (“IEC”) before initiating an investigation, continuing IEC review of ongoing investigations, and obtaining and documenting the freely given informed consent of each of the subjects.
The requirements for the acceptance of data from clinical investigations conducted inside the US submitted to support IDE or other premarket submissions were changed to require a statement regarding compliance with FDA regulations for human subject protection, institutional review boards, and IDE regulations. If any of these regulations do not apply, or the investigation was not conducted in compliance with these regulations, a relevant explanation must be provided in the application or submission. From FDA’s perspective, the final rule now provides consistency in FDA requirements for acceptance of data from clinical investigations, regardless of the application or submission type. The final rule is effective for studies with enrollment beginning on or after February 21, 2019.