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FDA Proposes Updating Overseas Medical Device Clinical Study Requirements

NEW YORK (GenomeWeb News) – The US Food and Drug Administration wants to ensure that the clinical studies that are used to support medical device applications provide high quality data and results and that human subjects involved in these projects are protected, and it has now proposed updating the regulations covering what types of data it will accept.

The changes will affect medical device submissions involving clinical studies conducted outside the US that are seeking an investigational device exemption (IDE) and premarket notification, product development protocol applications, or a humanitarian device exemption. FDA is considering amending the IDE and 510(k) regulations for clinical studies conducted in the US.

FDA is proposing that studies conducted outside the US would have to be run in accordance with recognized good clinical practices (GCP), which would include obtaining and documenting the review and approval of the study by an independent ethics committee and documenting the freely given informed consent of the subjects involved in the studies.

The agency hopes that the proposed changes will update FDA's standards for such submission will protect the quality and integrity of data that are submitted and will better protect human subjects.

For clinical studies conducted within the US, FDA plans to require that 510(k) submissions and IDE applications include statements that are similar to those currently required in pre-market approval applications.

FDA said in its proposed rule change that it wants its acceptance policies to be consistent, regardless of what type of submission or application it is reviewing.

Under current regulations, studies that involve multinational research sites may have several types of standards that they may follow regarding their design, conduct, monitoring, auditing, and analyses, and FDA hopes that the proposed standards will bring require that all of these be in compliance with new, broadly recognized good clinical practices.

FDA will be accepting comments on the proposed rule change until May 28.

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