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Compliance In Focus
Posted by John Lehmann on Mon, Dec 15, 2014

Unapproved Devices on ClinicalTrials.gov?

Currently, trial results for are only required to be submitted to the online database for clearedUnapproved Devices on ClinicalTrials.gov or approved devices.  However, a November 19th proposal from the National Institutes of Health which would require trial results and descriptive information for devices and device indications that have yet to be cleared or approved by FDA would be posted on the public ClinicalTrials.gov website.  The proposal would give trial sponsors up to three years between the completion of the trial and when results need to be submitted to NIH if they are legitimately working towards reaching the market.

The proposed rule is a long-awaited document that is intended to implement and clarify the ClinicalTrials.gov provisions in the FDA Amendments Acts of 2007.  The FDAAA  requirements significantly expanded the government’s online database of clinical trials by requiring registrants and reports on a large portion of studies evaluating FDA-regulated devices and drugs. 

Results needed to be posted on the site, irrespective of the publication status of the data, for all trials that require registration once a product is cleared or approved, or within a year after a trial is complete, if the product was already approved.  The proposal clears up some lingering questions on several components of the law, which were intended to be addressed in a NIH mandate regulation.

The industry argument against mandating posting of trial results for unapproved products is it could give up valuable competitive information to other companies looking to enter the same market.  Because of this, Congress provided a special exemption for device trials in the FDAAA.  Even though sponsors are required to register device trials soon after they start, but the NIH must not make the registration information public until after the device is approved or cleared, according to the law.

The proposed NIH rule proposes that companies should submit results data to ClinicalTrials.gov  within one year after the completion date of the trial, even if the product or indication has not been OK’s by FDA.  But a company can gain an additional two-year delay on the need to submit results if it certifies to NIH that it plans to continue development for the product and that it is seeking or may seek approval/clearance with FDA.

The new proposal presents the possibility that device study results might be posted on the government site while descriptive information about the trail required for registration is out of public view.

Comments on the proposed rule are due by February 21st.  In addition to feedback on the proposals, NIH also requests comments on certain topics.  The agency, for instance, wants ideas on how it could legally allow trial registration information to be posted publically for devices that are not yet approved in cases where the sponsor would prefer the information in public.

What are your thoughts on the NIH proposal?   Please share your thoughts.

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Topics: NIH, Unapproved Devices, FDA ClinicalTrials.gov

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