FDA Updates: Pregnant Women Subjects and Medical Device Investigations

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The U.S. Food and Drug Administration (FDA) recently issued draft guidance on the inclusion of pregnant women in clinical trials, as well as updated regulations and guidance on acceptance of data from medical device investigations.


Draft Guidance on Inclusion of Subjects Who Are or Become Pregnant

On 9 April 2018, the FDA issued draft guidance (“Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials“) on how and when to include pregnant women in clinical trials. Studies may include pregnant women as subjects or may allow subjects who become pregnant to keep participating in the study.

The guidance discusses ethical considerations including:

  • FDA regulations that apply
  • Research-related risks to pregnant women
  • Types of studies that may include pregnant women
  • General guidelines for including pregnant women

CITI Program will continue to monitor the development of this guidance and update modules accordingly.


Updated Regulations and New Guidance on Medical Device Investigations

On 21 February 2018, the FDA amended its regulations for clinical investigations through the new rule “Human Subject Protection: Acceptance of Data from Clinical Investigations for Medical Devices.” The FDA also answered frequently asked questions through new guidance.

According to the new rule (effective 21 February 2019), data from a medical device investigation submitted to support a FDA application or submission must contain a statement about whether the study complied with FDA regulations or whether it was conducted in accordance with Good Clinical Practice (GCP) and supporting information. GCP compliance includes IRB review and approval and informed consent from subjects. There are exceptions to this rule, and a sponsor may request a waiver under certain circumstances.

This rule applies to medical device applications and submissions (such as investigational device exemption [IDE] applications, premarket notifications, and humanitarian device exemption [HDE] applications). The affected FDA regulations were updated.

It is important to note:

  • For investigations conducted in the U.S., the investigator/sponsor must state whether the investigation complied with FDA regulations at 21 CFR 50, 56, and 812.
  • For investigations conducted outside the U.S., the investigator/sponsor must state whether the investigation complied with GCP and supporting information.
  • For multicenter investigations conducted inside and outside the U.S., the investigator/sponsor must state whether the:
    • Investigations in the U.S. complied FDA regulations at 21 CFR 50, 56, and 812.
    • Investigations outside the U.S. complied with GCP and provide supporting information.

CITI Program has updated affected modules to reflect the current FDA regulations and guidance.