Under the provision, custom medical devices specifically tailored to a single patient are exempt from submitting premarket approval submissions.
“[T]he 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,” the FDA said in a statement.
The agency said the updated definition of custom devices will ensure more clarity and consistency for device manufacturers.
To read the final rule and specific custom device requirements, click here.
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