The draft guidance, which is due for release Tuesday, describes “special considerations that apply when using such data, including applicability to populations within the US and study design issues,” according to notice published Monday.
The agency says that sponsors may choose to conduct multinational clinical studies under a variety of scenarios, though “certain challenges” exist in using data derived from studies of devices from sites outside the US to support an FDA decision.
“These challenges may include differences between the OUS (outside the US) and US clinical conditions, regulatory requirements (including human subject protections), and/or study populations that may be sufficient to affect the adequacy of the data for use in establishing the safety and/or effectiveness of the studied device,” the FDA says.
Medical device CROs will be keen to understand how the FDA will look to assess such data and what types of details they should focus on.
“This guidance focuses on considerations sponsors of device submissions should take into account when initiating, or relying on previously collected data from, an OUS clinical study to support an Investigational Device Exemption, Premarket Notification (510(k), De Novo Petition, Humanitarian Device Exemption, or Premarket Approval Application,” the agency says.
Device manufacturers submitting clinical data from outside the US are also required to provide detailed information about the research facilities and qualifications of the trial’s clinical investigators, a protocol summary, a results summary, a device description, the demonstration of scientific validity for any data gathered, and a number of other assurances concerning informed consent, study protocol, and sponsor monitoring, according to medical device CRO Aptiv Solutions, which is now integrated into Icon as its Medical Device and Diagnostics Research Division.
“Assuming that collected data are scientifically valid and compliant, the clarity provided by this guidance could shorten the clinical trial cycle time, expedite data collection, and move more products into the global market faster. This increase in efficiency would certainly be bolstered if these trials also employ smart strategies such as adaptive design, risk based monitoring, and early collection of health economic data,” Vicki Anastasi, VP and Global Head of Medical Device and Diagnostics Research at Icon told Outsourcing-Pharma.com.
Previous agency guidance added a requirement that foreign trial sites be administered according to accepted Good Clinical Practices, which altered current policy allowing for regional variance in the standards applied to a clinical trial, with clinicians and sponsors able to adopt the standards which are most commonly accepted at the location of the trial site.
The FDA also previously sought assurances that investigators were trained in GCP compliance.