FDA has proposed a rule that could significantly affect the timeline and pathway to market for medical devices. Under the proposal, foreign clinical studies would have to comply with Good Clinical Practice (GCP) if those studies will be used to support certain submissions, including an investigational device exemption (IDE) application, a Section 510(k) premarket notification, and a premarket approval (PMA) application. Under current regulations, FDA will accept data from clinical studies in support of a PMA application that are conducted outside the U.S. if the data are valid and if the investigator has conducted the studies in conformance with the Declaration of Helsinki or the laws and regulations of the country in which the research is conducted, whichever accords greater protection to the human subjects. 21 C.F.R. § 814.15. Current premarket notification regulations in part 807 and IDE regulations in part 812 do not address the requirements for FDA acceptance of data form clinical studies. Although FDA states that the proposed requirements would not generally apply to most 510(k) submissions, including those relying on literature only, the proposal could affect the traditional flexibility of the 510(k) program.

The requirements for FDA acceptance of data from foreign clinical studies would include:

  • A statement that the study was conducted in accordance with GCP;
  • Initial approval and ongoing review by an independent ethics committee (IEC);
  • Documentation of informed consent;
  • A statement assuring the availability of the data through an onsite inspection.

In addition, there would be new requirements for supporting information to be submitted when foreign clinical studies will be used to support an IDE or a device marketing application. These include:

  • Information about the research facilities, IEC, and clinical investigator, including the investigator’s qualifications;
  • A detailed summary of the protocol and results of the study, and certified copies of case records upon request;
  • Either a statement that the device used in the clinical study is identical to the device that is the subject of the submission or application, or a detailed description of the device and each important component and a comparison to the device that is the subject of the submission or application;
  • For safety and effectiveness studies, a discussion demonstrating that the data and information constitute valid scientific evidence
  • A summary of the IEC’s decision to approve or modify and approve the study A description of how informed consent was obtained and what incentives were provided to subjects in the study
  • A description of how the sponsor(s) monitored the study and ensured that the study was carried out consistent with the study protocol; and
  • A description of how investigators were trained to comply with GCP and to conduct the study in accordance with the study protocol.

The proposed rule would also amend existing IDE and premarket notification regulations to match existing PMA requirements for the acceptance of data from domestic clinical studies. The amendments are intended to standardize FDA requirements for the acceptance of clinical data for all types of medical device submissions.

The proposed rule, Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices, 78 Fed. Reg. 12,664 (February 25, 2013) is available here http://www.gpo.gov/fdsys/pkg/FR-2013-02-25/pdf/2013-04201.pdf.

Comments should be submitted by May 28, 2013.