On February 21, 2018 the US Food and Drug Administration (FDA) published a final rule on FDA’s standards for accepting data from clinical investigations for medical devices. The new rule states that sponsors and applicants conducting clinical investigations outside of the United States conduct in accordance with Good Clinical Practices (GCPs) when being submitted for medical device applications. Additional criteria discuses investigations within the United States that requires sponsors and applicants to comply with FDA regulations for human subject protection, institutional review boards, and investigational device exemptions.
In the Federal Register, FDA notes that GCP “includes review and approval by an IEC before initiating an investigation, continuing IEC review of ongoing investigations, and obtaining and documenting the freely given informed consent of subjects.”1
An article published by Applied Clinical Trials mentioned some key takeaways to note following the final rule.
- Medical device companies will need to implement new standard operating procedures and systems to ensure GCP compliance for out of US clinical trials.
- There could be additional education of contract research organizations (CROs) and outside of the US clinical trial sites around GCP compliance.
- Agreements pertaining clinical trial agreements will need to be modified to assure GCP compliance.
- Additional costs of GCP compliance may affect strategic decisions about where to conduct future clinical trials.
Pearl Pathways offers full service US-based niche CRO services. We understand that initiating, managing, monitoring, and closing out multi-site studies requires significant time. Therefore, we take a leadership position for our clients by leveraging our clinical expertise to navigate clinical trials from study design to completion. To learn more click here.
1https://www.gpo.gov/fdsys/pkg/FR-2018-02-21/pdf/2018-03244.pdf