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High-Risk Companion Diagnostics Need IDEs Prior To Drug Trial, FDA Says

 
• By Sue Darcey

Companies planning to co-develop an in vitro companion diagnostic alongside a therapeutic should be certain that the assay has been analytically validated and, if high risk, has won investigational device exemption before the drug trial begins, FDA warns in a July 14 draft guidance.

Before starting a clinical trial for a drug that will be paired with a companion in vitro diagnostic, sponsors must ensure that the diagnostic assay has undergone analytical validation and, if it’s a high-risk IVD, has earned an investigational device exemption (IDE) approval, the US FDA says in a new draft guidance on co-development of drugs and diagnostics.

The agency issued a guidance on the submissions and approval process for companion IVDs, defined as tests "providing information essential...

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A Year After Exiting The Ventilator Market, Medtronic Recalls Thousands Of Newport Devices

 
• By Brian Bossetta

After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.

MDUFA VI Launches With Public Meeting, Call For Comments

 
• By Elizabeth Orr

Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.

Permanent FDA Top Lawyer Expected After HHS Counsel Confirmation

 
• By Sue Sutter

Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.