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Jan. 13 --A draft guidance from the Food and Drug Administration released Jan. 13 aims to clarify for the devices industry how to implement a provision in the Food and Drug Administration Safety and Innovation Act (FDASIA) that would exempt certain custom devices from premarket approval requirements.
The draft was announced in the Federal Register Jan. 14 (79 Fed. Reg. 2446). Comments are due March 17 (FDA-2013-D-1601), the agency said.
The draft guidance describes what information the FDA proposes should be submitted in a custom device annual report, and provides recommendations on how to submit an annual report for devices distributed under the exemption.
According to the agency, FDASIA required the changes to the custom device exemption contained in Section 520(b) of the Federal Food, Drug, and Cosmetic Act.
In addition to the new provisions for establishing a custom device, the FDA said, manufacturers will be limited to using the device only for treating a “sufficiently rare condition, such that conducting clinical investigations on such device would be impracticable.”
Under FDASIA, devices that qualify for the custom exemption are limited to no more than “five units per year of a particular device type” that otherwise meet all the requirements to qualify for the exemption, the FDA said.
The FDA said the draft guidance also provides draft definitions of terms used in the exemption, and explains how the agency plans to interpret the concept of “five units per year of a particular device type.”
In November 2012, the agency asked for comments on its plan to implement the exemption .
One of the main topics of contention among stakeholders was the five-device limit. In comment letters, a device industry group and medical societies told the FDA not to place rigid limits on the production of customized medical devices .
At the same time, consumer advocates said the FDA needs to clarify just how it will enforce a cap on making custom devices exempt from premarket approval requirements, and cautioned against possible loopholes that would allow potentially unsafe devices onto the market.
The FDA said it took the comments into consideration when drafting the guidance.
The FDA in the draft said it interprets the five units in terms of five new custom device cases per year (i.e., five new patients for the patient-focused custom device or five new physicians for the physician-focused custom device, assuming all other required elements for the custom device exemption are satisfied).
The five-unit limit includes all devices provided by a manufacturer to, and remaining in the possession of, the ordering physician and/or the patient, the draft said.
“FDA does not intend to include in the tally of five units per year any extra units that are produced for a unique case because of sizing concerns, so long as those devices not used for that unique case are returned to the manufacturer, and not redistributed without either valid marketing authorization or for a subsequent valid custom device case,” the agency said.
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The draft guidance is at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM380497.pdf.
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