FDA releases two new draft guidances

FDA releases two new draft guidances

November 11th, 2011 // 1:51 pm @

The FDA this week issued two new draft guidances and launched a new standard operating protocol for requesting new data from products undergoing pre-market review.

In two draft guidances the federal watchdog agency offered new approaches to feasibility studies for products under investigational device exemption and outlined the process for device makers who want to conduct clinical trials.

“Today’s guidance documents give sponsors and FDA device reviewers more flexibility to start investigational studies sooner while maintaining appropriate human subject protections, and they propose efficient ways to support product or study design changes once the study begins,” Center for Devices & Radiological Health director Dr. Jeffrey Shuren said in prepared remarks.

In the guidance regarding feasibility studies the FDA aims to better inform final product designs and allow studies to start earlier in the device development process than previously allowed.

In the guidance regarding clinical studies the agency clarifies its standards for approving trials, including allowing patient enrollment while issues with the device are being resolved and allowing small studies while data is gathered to support a larger trial.

Wednesday also marked the effective date for a revised standard operating procedure for making changes in data requirements for pre-market submissions in process. The SOP provide criteria under which changes in data requirements can stay at the branch level and when requests need to be escalated to a higher authority.

The document states that management level authority is needed for any reviewers wishing to request additional data from a company that wasn’t previously agreed upon, and the new data requests must represent “the least justified burden on the applicant.”


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