FDAnews Device Daily Bulletin

Devicemakers Seek Changes to FDA’s Proposed List of Exempt Devices

June 5, 2017

Device manufacturers have called for the FDA to modify and clarify its proposed list of class II devices exempt from premarket notifications.

Roche Diagnostics commended the agency for its flexible approach to exempting analyzers and testing systems, but called for clarification on why some analyzers are exempted while others are not.

It is unclear, Roche said, whether the “limitations to exemption” provision applies to diagnostic instruments on the list if the labeling does not include clinical claims. Roche urged the agency to review the exemption and update it to take into account “advances in medical and regulatory understanding.”

Becton Dickinson and Company, meanwhile, called on the agency to grant a partial exemption for devices used for myelography procedures because of their similarities to arthography devices.

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