On February 21, 2018, the Food and Drug Administration (FDA) published a Final Rule, amending its regulations on acceptance of data from investigations for medical devices that are performed outside of the United States as well as modifying certain regulations applicable to data from US-sited investigations. The Final Rule does not go into effect until February 21, 2019 – a full year after promulgation. The FDA also issued guidance in the form of Frequently Asked Questions (FAQ) addressing the new regulations. In the FAQ document, the FDA explained its rationale that more research and marketing applications and submissions are being submitted that are supported by foreign investigations and that it was seeking to make its requirements more uniform.
Among other provisions, the Final Rule will require that data submitted from clinical investigations conducted outside of the United States be derived from investigations conducted in accordance with good clinical practice (GCP). However, as FDA discussed, the GCP requirements will not apply to all clinical data contained in submissions, only the data intended to support an investigational device exemption (IDE), a premarket approval application (PMA), a product development protocol application (PDP), or a humanitarian device exemption (HDE) application.
While FDA emphasized that it does not intend to regulate clinical investigations conducted outside the US, it said that the agency expects that these investigations will be conducted in accordance with local laws and regulations. The FDA’s GCP standard would be imposed as an additional layer, to the extent the local laws and regulations do not incorporate such a standard.
The Final Rule contains language providing the potential for a waiver from the GMP requirements and also certain exemptions for investigations of non-significant risk devices and investigations meeting enumerated criteria. In the alternative, a sponsor or applicant can provide an explanation of departure from GMP for the FDA’s consideration. The FDA provided an example — if a sponsor or applicant cannot meet GCP for an investigation because a country’s GCP requirements are not congruent with the definition in the rule or with a GCP standard, they may either provide an explanation of the departure from GCP or request a waiver. The FDA explained that it will take this information into account on a case-by-case basis when considering the extent to which it can rely on the data.
This post was co-authored by Chelsea Sousa, legal intern at Robinson+Cole. Chelsea is not yet admitted to practice law.