On February 21, 2018, the Food and Drug Administration (FDA) issued a final rule amending the Agency’s regulations on acceptance of data from clinical investigations form medical devices. The final rule amends requirements for data submitted from clinical investigations conducted outside of the United States (OUS) that is intended to support an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a request for De Novo classification, a premarket approval (PMA) application, a product development protocol (PDP) application, or a humanitarian device exemption (HDE) application. The effective date for the final rule will require compliance for all studies in which enrollment begins on or after February 21, 2019. In addition to this final rule, FDA issued a new guidance document for industry that is intended to help sponsors comply with the new requirements under the final rule.

The preamble to the final rule notes that the amended regulations are intended to help ensure the quality and integrity of data obtained from OUS investigations and the protection of human subjects. In addition, FDA believes that the amendments made by the final rule create consistency in the Agency’s requirements for acceptance of data from clinical investigations for all medical device application and submission types whether conducted inside or outside of the United States. The major change made by the final rule requires that clinical investigations conducted inside and outside of the United States conform to good clinical practices (GCP), if the data from those investigations will be used to support an IDE or device marketing application or submission.