FDA has begun requiring that studies of medical devices run outside of the U.S. comply with good clinical practices (GCPs).
The requirement applies to clinical trials that enroll their first subject on or after Feb. 21.
FDA outlined the requirements in a final rule intended to ensure data quality and integrity last year but gave the industry 12 months to prepare.
The implementation of the final rule ends FDA's multi-year move toward stronger standards for medical device clinical trials. In 2013, the agency released a proposed rule laying out the conditions under which it will accept data to support investigational device exemptions, 510(k) clearances, requests for De Novo classification, premarket approvals, product development protocols or humanitarian device exemptions. In 2018, FDA finalized the proposal despite some pushback.
The final rule was issued 2/21/18 and provides consistency in #FDA reqs for acceptance of data from clinical investigations for devices, whatever the application/submission type and helps ensure data quality/integrity. https://t.co/7Qwo0aKskQ pic.twitter.com/wnHsBj7h22— Scott Gottlieb, M.D. (@SGottliebFDA) February 22, 2019
FDA's core intention to apply GCPs to clinical trials of medical devices survived the review process. In revised guidance documents released to support the final rule, FDA states it will refuse to accept 510(k) filings that lack either a statement that ex-U.S. studies were performed to GCPs, a waiver or an explanation for the deviation from the regulatory standards. FDA wants supporting evidence, too.
The agency received broad backing for the proposal when it floated it in 2013, with the medical device lobby AdvaMed stating it "strongly supports efforts to standardize medical device [GCPs] as a mechanism to help ensure human subject protection."
However, FDA also received pushback in some areas, in part due to concerns that the lack of a global harmonized set of medical device GCPs and definitions would create problems. FDA downplayed those concerns in its final rule.
"FDA's rule does not identify a specific GCP standard for sponsors and applicants to follow. Instead, the rule includes a definition of GCP ... that embodies well recognized GCP principles and has been generally accepted. This allows sponsors of clinical investigations conducted outside the United States to determine an appropriate GCP standard," the agency wrote in its final rule.
That flexibility could benefit sponsors but also puts the onus on them to select an appropriate GCP standard. To help companies make this decision and otherwise comply with the final rule, FDA has published new and revised guidance. FDA is set to hold a webinar on Mar. 19 to help sponsors better understand the implementation of the final rule.