FDA Acceptance of Clinical Data Collected Outside the United States in Support of Medical Device Submissions

Gordon MacFarlane, Ph.D., RAC

Senior Manager, Regulatory Affairs, ICON plc

The US Food and Drug Administration (FDA) amended requirements for the acceptance of clinical data collected outside the United States to support medical device submissions, effective 21 February 2019.  The amended requirements apply to premarket approval (PMA), humanitarian device exemptions (HDE), investigational device exemptions (IDE), 510(k), product development protocols, and De Novo classification request submissions.  

As of the effective date, acceptable data must be collected in compliance with Good Clinical Practice (GCP).  GCP for medical device clinical trials is outlined in the ISO Standard 14155:2011.  ISO 14155 is the required standard for medical device trials in most of the developed world and is a recognized consensus standard with US FDA (Recognition # 2-205).

Prior to the effective date, investigators are required to follow either the Declaration of Helsinki, or local regulations, depending on which one provides the most stringent human subjects protections.  The changes would apply a single standard, particularly with regard to informed consent and review and approval by an independent ethics committee.

Since ISO 14155 compliance is already a requirement in most jurisdictions, the amended requirements should not create issues for most manufacturers.  On 18 February 2018, the FDA generated a guidance document, Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Question, addressing the frequently asked questions regarding the acceptance of medical device clinical data generated outside the United States.

For IVD manufacturers using de-identified samples that do not have specific informed consent for the study they are being used in, the FDA intends to exercise the same enforcement discretion it currently applies to studies conducted within the United States as outlined in Section IV the guidance, Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable, issued 25 April 2006.

ICON’s dedicated Medical Device and IVD regulatory and quality experts are available to help you understand these changes and how they impact your products. For assistance with any of the above items, or any aspects of medical device or IVD regulations, please contact us at www.iconplc.com/devices.