Regulatory Focus™ > News Articles > FDA Proposal Would Require all Device Trials, Regardless of Location, to Adhere to FDA Regulations

FDA Proposal Would Require all Device Trials, Regardless of Location, to Adhere to FDA Regulations

Posted 26 February 2013 | By Alexander Gaffney, RAC

US regulators have proposed a regulation that would require that all clinical studies on investigational and already-approved medical devices conducted outside the US adhere to good clinical practice guidelines.

The change would notably require sponsors to obtain approval from an independent ethics committee (also known as an Institutional Review Board or an Ethical Review Board), and obtain and document informed consent of study participants,

"The proposed rule is intended to update the standards for FDA acceptance of data from clinical studies conducted outside the US and to help ensure the protection of human subjects and the quality and integrity of data obtained from these studies," FDA wrote.

Regulators noted that the proposed rule would also affect requirements for studies conducted inside the US as well, which they said would make requirements for clinical data acceptance more consistent.


FDA has for decades regulated medical devices, and regularly accepts data from clinical studies conducted outside the US so long as the trial is conducted to certain standards. In particular, those studies must meet parts 812-4 of chapter 21 of the Code of Federal Regulations (21 CFR 812-4), which state that data must be scientifically valid and must have been collected per the ethical guidelines of the Declaration of Helsinki or local laws (whichever offers stronger protection to research subjects).

This data is most commonly used in support of an application that includes data from the US, but FDA encourages sponsors to meet with it if the application will be "based solely on foreign clinical data."

Those requirements are less stringent than required for clinical trials conducted within the US, which are held to various US-specific regulations such as 21 CFR 56 (IRBs) and 21 CFR 50 (informed consent).

However, these requirements are just for Premarket Approval (PMA) applications, as FDA's 510(k) and Investigational Device Exemption (IDE) regulations do not address FDA requirements for the acceptance of data from either inside or outside the US.


These inconsistencies were-and are-troubling to FDA, which argues in the proposed regulation that it "believes that the requirements for FDA's acceptance of data from clinical studies should be consistent regardless of the type of submission or application in which the data re submitted to FDA."

Why the need for consistency? Several reasons, regulators say. First, standards continue to evolve far beyond those first elucidated by the Helsinki Declaration, including the development of good clinical practice (GCP) guidelines issued by the World Health Organization, the International Standards Organization, the Pan American Health Organization and the International Conference on Harmonisation (ICH), among others.

Many of these standards are adopted either in whole or in part by FDA, and it said it now wants to amend 21 CFR 814.15, 807 and 812 to require all clinical trials conducted for medical devices to meet GCP standards set by FDA.

"We believe that the proposed standard helps to ensure adequate human subject protection and the quality and integrity of data obtained from such studies, while also being sufficiently flexible to accommodate differences in how countries regulate the conduct of clinical research and obtain informed consent."

The change should also make sure data is of the same quality and integrity, regardless of its geographic source, FDA argued. Some of the most crucial parts of GCP highlighted by FDA include provisions of assurance that results are credible, accurate and monitored throughout the trial.

Protections for human subjects, too, will get an upgrade under the proposed rule, with FDA pushing a harmonized, "unifying approach, which may simplify such trials and decrease the regulatory burden on sponsors."

Could Costs Increase?

Still, that could raise regulatory compliance costs in foreign markets for devices, which would now need to meet FDA's standards as well as the standards of whatever locale the trial is taking place in. A recent report by the Organization for Economic Co-operation and Development (OECD)-an organization of which the US is a part-called for clinical trials standards to be made more flexible to decrease costs.

FDA took a different approach to the same argument. "Under the current regulations, in a study involving multinational investigational sites, several different standards may be followed leading to increased complexity in the conduct of the study." By adopting a single standard, then, sponsors might stand to save money by only needing to worry about a single standard instead of potentially dozens.

FDA also said that under the rule, it would require that 510(k) and IDE applications adhere to the same standards as PMAs. This will "help ensure the protection of human subjects and the quality and integrity of data obtained from these studies," it wrote.

Comments on the proposed rule are due by 28 May 2013.

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