On Wednesday, February 21st, the FDA released a final rule entitled “Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices.” The new rule amends the Agency’s acceptance criteria regarding data generated from clinical trials conducted outside the US, stating that they must be conducted in compliance with the Agency’s GCP standards. The rule applies to sponsors or applicants of the following medical device submissions:
The final rule states that these trials must be “conducted in accordance with good clinical practice (GCP), which includes obtaining and documenting the review and approval of the clinical investigation by an independent ethics committee (IEC) and obtaining and documenting freely given informed consent of subjects, which includes individuals whose specimens are used in investigations of medical devices.”
Under the new rule, sponsors and applicants will now be required to provide statements concerning the trial’s GCP compliance when clinical data is submitted in support of device applications and submissions.
In a guidance document published alongside the final rule, FDA stated that “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, ethically derived data. Conformance with GCP is one way to help ensure clinical data are credible, accurate, and ethically procured.”
As such, sponsors relying on data from investigations conducted in the US will be required to state whether the investigation complied with 21 CFR parts 50, 56, and 812. “These regulations address data quality and integrity and human subject protection and are considered part of FDA’s GCP regulations.” Moreover, sponsors relying on data from trials conducted outside the US will be required to include a statement explaining how the investigations conform with GCP and provide supporting information that demonstrates this conformance.
The rule was originally issued as a proposed rule on February 25, 2013. However, there are numerous changes between the recently published final rule and the proposed rule issued five years ago. Some of these changes include:
After the proposed rule was published, the FDA received numerous comments regarding how the rule will impact international harmonization and the regulation of international trials. In response to these remarks, FDA stated that “it has and will continue to promote global harmonization in many aspects of medical device development and regulation.”
In both the final rule and the accompanying guidance document, FDA states that it does not intend to regulate clinical trials conducted outside the US. Furthermore, the Agency notes that it expects that “foreign clinical investigations will be conducted in accordance with local laws and regulations. The requirements outlined in the rule allow the flexibility needed to accommodate those laws and regulations. The application of a GCP standard would be in addition to the local laws and regulations to the extent that the local laws and regulations do not incorporate such a standard. If needed, the rule allows sponsors and applicants to explain why GCP was not followed and to describe the steps taken 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 addition, “FDA’s rule does not identify a specific GCP standard for sponsors and applicants to follow. Instead, the rule includes a definition of GCP in § 812.28(a)(1), which is consistent with the definition in § 312.120 (21 CFR 312.120), that embodies well recognized GCP principles and has been generally accepted. This allows sponsors of clinical investigations conducted outside the United States to determine an appropriate GCP standard to use for clinical investigations that will produce data to support an IDE or a device marketing application or submission to FDA."
The final rule is set to take effect on February 21, 2019. The Agency decided to wait a full year after releasing the new regulation in order to give sponsors and applicants ample time to make any necessary changes (i.e., to their internal operating procedures, study planning, etc.), and to incorporate the principles of GCP and compliance with the requirements of the rule for investigations that will support an IDE or device marketing application or submission.
The FDA also notes that the rule will only apply to clinical trials that enroll the first subject on or after the effective date of the rule.
Additional details on the pending requirements of the final rule are available in the Federal Register and the FDA’s accompanying guidance document.
Are you in the process of developing a medical device that will be subject to these provisions? We can help make sure you are compliant with all of the final rule’s requirements. Contact us today to learn more about our services and how we can help you obtain approval for your medical device.
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