When seeking FDA approval of medical devices, manufacturers should keep in mind how and where their data is collected, according to a new draft guidance the agency released last week.
Data collected from outside the United States (OUS) has been allowed by the FDA for a long time now, but this draft guidance—called “Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States”—was released to make things as clear and direct as possible for both manufacturers and FDA staff, said Jennifer Dooren, FDA press officer.
“Certain challenges exist in using data derived from foreign studies of devices to support an FDA marketing authorization,” Dooren told RadiologyBusiness.com in an email. “This guidance is aimed at device makers and what they should consider if they intend to rely on OUS data.”
When manufacturers present OUS data, Dooren said, they must consider where the study was conducted, and how that location might differ from the United States. “This includes differences in clinical conditions, the study populations, and regulatory requirements,” Dooren said.
In one example mentioned in the draft guidance, the FDA noticed a potential bias based on the population the study was conducted on. The manufacturer then provided additional detailed analysis, easing the FDA’s fears and gaining approval under the condition that a post-approval be conducted in the United States.
The FDA also closely examines the ethical standards of the country where the study was conducted. In fact, in February 2013, the FDA proposed a rule (Human Subject Protection: Acceptance of Data from Clinical Studies for Medical Devices) that would require OUS studies to be conducted in accordance with good clinical practice (GCP). The rule is not final yet, Dooren said, but it is specifically mentioned in the draft guidance.
With so much to consider, the FDA recommends manufacturers begin seeking approval of their medical devices as early as possible if any OUS data is a part of the application.
“We suggest that device makers who plan to initiate or rely on an already-conducted OUS device study seek input from the FDA at the earliest possible stage to help increase the likelihood that the data obtained from OUS studies can fully or partially support a U.S. marketing application,” Dooren said.
There will now be a 90-day comment period, and any feedback will be considered by the FDA before this draft guidance becomes final.