On February 21 the US Food and Drug Administration (FDA) issued a final rule on FDA’s standards regarding the requirements for accepting the data obtained in clinical trials on medical devices. According to this rule, for submitting medical device applications it will be necessary for sponsors and applicants to confirm that clinical studies conducted outside USA meet Good Clinical Practices (GCPs) standards. A sponsor or an applicant will also have to provide the supporting information which confirms that the trial was conducted in compliance with GCP.
The effective date for this regulation is February 21, 2019, exactly one year after its publication. However, the new rule won’t be applied to foreign clinical studies which started before the effective date. The beginning of the clinical investigation implies the date when the first subject was enrolled. A subject will be considered to be included only after signing the informed consent form (by the subject or his authorized representative). Therefore, clinical investigations outside the US which included the first subject before the rule’s effective date will be regulated by the old requirements in 21 CFR § 814.15. FDA will accept the results of these studies if the investigations were conducted according to the Declaration of Helsinki or the national laws and regulations, and the data of these studies are valid.