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The US Food and Drug Administration (FDA) on Tuesday released a final rule that amends its regulations on the definition of a custom device so as to include new statutory requirements under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA).

Under the revised provision, as under the original custom device exemption, a device that meets the qualification of a custom device is exempt from 510(k) and Premarket Approval (PMA) submissions.

“The final rule explained that the exemption for manufacturers of custom devices is intended to apply only to those who are manufacturing a custom device to fit the needs of a particular patient, so the manufacturer will not be required to file a premarket notification for each particular device,” FDA said.

FDA says the reformed definition of a custom device will ensure clarity and consistency, particularly as some manufacturers might be unaware that certain devices they distribute as custom devices do not meet the statutory definition and are subject to premarket review.

In 2014, FDA issued final guidance on custom device exemptions, explaining the new statutory provisions and defining certain terms used in connection with the custom device exemption and how FDA interprets the devices that may qualify for the exemption.

The guidance also describes in further detail what information should be submitted in an annual report, and provides recommendations on how to submit an annual report for custom devices distributed under the exemption.

The final rule issued Tuesday comes without notice and comment because FDA says it “only corrects the implementing regulation to restate the statute,” adding, “[W]hen regulations merely restate the statute they implement, notice-and-comment procedures are unnecessary.”

Read More – Source: FDA Amends Definition of Custom Medical Device | RAPS