UDI Rule for Medical Devices Finally Issued
"MDMA believes FDA has underestimated the costs of the healthcare system from implementing UDI," the organization said in its comment letter last Nov. 7.
"This transition will require the medical technology industry to spend significant resources to comply. With smaller companies facing a looming medical device tax, increased user fees, and a reduction in venture capital investment, allowing as much flexibility and time to comply is critical."
One significant change between the proposed rule and the final rule is that the proposed rule did not require GUDID to receive information about whether a device is incompatible with a magnetic resonance imaging machine, which has resulted in adverse events and patient harm. The final rule requires GUDID to receive information about "whether a patient may be safely exposed to MRI or similar technologies while using the device or while the device is implanted in the patient."
The patient advocacy group Public Citizen also applauded the rule but lamented its delay and implementation timetable.
"More prompt action by the FDA likely would have prevented numerous deaths and injuries related to unsafe medical devices," says director Michael Carome.
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