On February 25, 2013, the Food and Drug Administration (FDA) issued a proposed rule to amend its regulations on data acceptance from clinical studies for medical devices. The proposed rule would require clinical studies conducted outside the United States (U.S.) used to support any device-related application or submission — investigational device exemptions (IDEs), (510(k)) pre-market notifications, pre-market approvals (PMAs), product development protocols (PDPs), and humanitarian device exemptions (HDEs) — be conducted in accordance with good clinical practices (GCPs). The proposed rule would also amend 510(k) and IDE regulations to address requirements for FDA acceptance of data from clinical studies conducted within the U.S.
Proposed Rule
The proposed rule amends FDA regulations on data acceptance from medical device clinical studies. The primary differences between the proposed rule and existing regulations are as follows:
- Changes to Human Subject Protection Requirements in Foreign Studies: Current regulations allow FDA to accept foreign clinical data in support of PMAs in accordance with the Declaration of Helsinki or the laws and regulations of the country where research is conducted, whichever affords greater protections to human subjects. FDA proposes to replace this rule with a unified approach, requiring all foreign clinical studies supporting PMAs to comply with specified GCP requirements;
- Extension of Human Subject Protection Requirements to Foreign Studies Supporting Non-PMA Submissions: Current regulations do not specify criteria for FDA to accept foreign clinical data in support of 510(k)s, IDEs, HDEs, and PDPs. The proposed rule would require GCP compliance for foreign studies used to support each of the aforementioned submissions to varying degrees, depending on whether the device poses a significant or non-significant risk; and
- Extension of Human Subject Protection Requirements to U.S. Studies Supporting Non-PMA Submissions: Currently, FDA regulations require a PMA applicant to certify various aspects of GCPs are met for studies conducted within the U.S. The proposed regulation would extend these certification requirements to U.S. studies conducted to support 510(k), HDE, and IDE submissions.
In addition, the proposed rule adds a definition of GCPs as “a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials in a way that provides assurance the data and reported results are credible and accurate and that the rights, safety, and well-being of trial subjects are protected.” Key elements of GCPs include review and approval by an independent ethics committee (IEC) prior to initiating a study, continuing study review by an IEC, and obtaining and documenting the subject’s freely given informed consent before the clinical study commences.
Discussion
According to FDA, these steps will “help provide greater assurance of the quality and integrity of data obtained from clinical studies conducted outside the U.S. submitted in support of an application or submission to FDA.” The GCP requirements in the proposed rule track existing regulations for the acceptance of foreign clinical study data submitted in support of drug or biological product applications.
FDA provided the following rationale in support of the proposed rule: 1) to update standards for the protection of human subjects and create consistency in human protection requirements across submissions for drugs, biologics, and medical devices; 2) to ensure the quality and integrity of clinical data used to support submissions; 3) to reduce the complexities facing investigators of multinational studies; and 4) to clarify the requirements for FDA acceptance of data from clinical studies in support of IDEs and 510(k)s.
Comments on the proposed rule are due to FDA by May 28, 2013.
The proposed rule is available by Clicking Here