FDA Lays Out Benefit-Risk Framework For Sponsors Of IDE Applications

FDA recommends in a draft guidance that sponsors of investigational device exemption (IDE) applications for human clinical studies include with their filings a summary of key considerations for benefit-risk assessment that includes plans to mitigate risks associated with the device trial and benefits to study subjects and others. The agency says in the draft guidance that including a summary of the benefit-risk assessment laid out in the document can help a sponsor achieve a benefit-risk determination that allows studies to...