FDA made public that the effective date for compliance with the final rule on “Human Subject Protection – Acceptance of Data from Clinical Investigations for Medical Devices.” According to the announcement from FDA, the “update relates to the standards for accepting clinical data from clinical investigations conducted inside and outside the United States” with the stated purpose of “protecting human participants, and to help ensure the quality and integrity of data obtained through such investigations.” This rule applies to:
- Investigational device exemptions (IDE)
- Premarket notifications (510(k))
- Requests for De Novo classification
- Premarket approvals (PMA)
- Product development protocols (PDP)
- Humanitarian device exemptions (HDE)
The major take away here is FDA is requiring that data submitted from clinical investigations conducted outside the United States be from investigations conducted in accordance with good clinical practice (GCP), which includes review and approval by an independent ethics committee (IEC) and informed consent from subjects. Many with software responsibilities may not be familiar with GCP … What is Good Clinical Practice (GCP)?
GCP is defined in 21 CFR 812.28(a)(1) 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.” GCP includes review and approval (or provision of a favorable opinion) by an independent ethics committee (IEC) before initiating an investigation, continuing review of an ongoing investigation by an IEC, and obtaining and documenting the freely given informed consent of the subject (or a subject’s legally authorized representative, if the subject is unable to provide informed consent) before initiating an investigation. GCP does not require informed consent in life-threatening situations when the IEC reviewing the investigation finds, before initiation of the investigation, that informed consent is not feasible and either that the conditions present are consistent with those described in 21 CFR 50.23 or 50.24(a), or that the measures described in the protocol or elsewhere will protect the rights, safety, and well-being of subjects.”
Read more at:
https://www.govinfo.gov/content/pkg/FR-2018-02-21/pdf/2018-03244.pdf
See our post on significant vs non-significant risk devices: https://www.softwarecpr.com/2020/11/distinguishing-significant-and-nonsignificant-risk-devices/
