Blog Tag: HDE
FDA Issues Draft Guidance Document on Acceptance of Foreign Medical Device Clinical Data
The FDA recently issued a draft guidance document regarding its policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for medical devices. In view of the “increasingly global” nature of clinical research, the FDA issued the guidelines to clarify the standards under which foreign clinical data will be accepted.
Under the FDA’s existing framework, and in particular for Premarket Approvals (PMA), the FDA will accept foreign clinical data if it conforms with the 1983 version of the Declaration of Helsinki, or the local rules of the country in which the clinical study was conducted. If using the local rules, the sponsor must detail any differences between the local rules and the Declaration, and explain why the local rules are more protective of human test subjects. One of the proposed rules would require that foreign clinical studies used to support PMAs, Investigational Device Exemptions (IDEs), Humanitarian Device Exemptions (HDEs), and 510(k)s be conducted according to good clinical practice (GCP).
The FDA also states that, for many device premarket applications, like 510(k)s, PMAs, and de novos, foreign clinical data “can be used to support clearance or approval of the application” as long as the data constitutes valid scientific evidence under 21 CFR 860.7. The FDA encourages sponsors to submit the foreign clinical studies for review through the FDA’s Pre-Submission process, before using the studies to support an application.
The draft guidance document further lists three special considerations that may be applied to foreign clinical studies to ensure that they satisfy FDA standards, namely (1) differences in clinical conditions, (2) differences in study populations, and (3) differences in regulatory requirements. These special considerations are intended to identify whether the results of a foreign clinical study can be generalized to apply to US clinical practices, the US population, and FDA requirements, respectively. To illustrate application of these special considerations, the FDA has provided 7 examples and explains the outcome of applying the special considerations to the examples.
According to the Federal Register, public comments on the draft guidance document must be submitted to the FDA by July 20, 2015. Comments may be submitted online to Regulations.gov, or mailed to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.