On November 19, 2012, the Food and Drug Administration (FDA) published a notice and an amendment to a proposed rule related to FDA’s implementation of the FDASIA, which was signed into law on July 9, 2012. In the notice, FDA announced that it is seeking information from all stakeholders (including patients, physicians, dentists, and manufacturers) on appropriate uses of the custom device exemption identified in section 520(b) of the FDCA. By way of background, FDASIA amended section 520(b) of the FDCA, to (among other things) establish criteria for a device to qualify for a custom device exemption. Under section 520(b) of the FDCA as amended, “custom devices” are exempted from performance standard or premarket approval requirements if (among other things): (1) the device is “created or modified in order to comply with the order of an individual physician or dentist (or any other specially qualified person designated under regulations promulgated by the Secretary after an opportunity for an oral hearing)”; (2) the device is not “generally available in the United States in finished form through labeling or advertising by the manufacturer, importer, or distributor for commercial distribution”; (3) the device’s purpose is to treat a “unique pathology or physiological condition that no other device is domestically available to treat”; and (4) the device is manufactured for the “special needs of such physician or dentist (or other specially qualified person so designated) in the course of the professional practice of the physician or dentist (or other specially qualified person so designated)” or by an individual patient named in such order. Manufacturers are limited to using the custom device only for the purpose of treating a “sufficiently rare condition, such that conducting clinical investigations on such device would be impracticable.” Additionally, production of the device must be limited to no more than five units per year of a particular device type. Lastly, under section 617 of FDASIA, manufacturers will be required to submit an annual report explaining their use of the custom device exemption.
FDA stated in the notice that it is specifically interested in receiving the following: (1) input on where use of the custom device exemption is appropriate; (2) specific instances where manufacturers, dentists, or physicians would have liked to use, or plan to use the custom device exemption for treatment of a sufficiently rare condition; (3) product areas other than orthopedic and dental devices where the custom device exemption may be useful; (4) the type of information manufacturers intend to require a physician, dentist, or other qualified person to submit to them when ordering a custom device; and (5) how often a custom device is ordered due to unusual anatomical features of the individual physician/dentist, or due to a unique need in the physician’s/dentist’s practice not shared by health professionals of the same specialty (i.e., a special need of a physician or dentist). Comments must be submitted by January 18, 2013.
FDASIA also required FDA to create a unique device identification (UDI) system by amending section 519(f) of the FDCA. Pursuant to this mandate, FDA published a proposed rule on July 10, 2012 setting forth proposed unique device identifier labeling requirements, proposed requirements relating to issuing Agencies and submission of data to the Global Unique Device Identification Database (GUDID), and proposed conforming amendments to several existing FDA regulations. The proposed rule included a phased implementation of the rule’s requirements. In the amendment to the proposed rule published on November 19, 2012, FDA adjusted the proposed effective dates for certain categories of devices. Specifically, under the proposed rule as amended, the requirements applicable to implantable, life-supporting, and life-sustaining devices would be effective no later than 2 years from finalization of the rule. Therefore, implantable, life-supporting, and life-sustaining devices that are not already subject to a 1-year effective date would be required to bear a UDI within 2 years following the publication of a final rule. Because labelers of devices labeled with a UDI must submit information concerning the device to the GUDID, all labelers of all implantable, life-supporting, and life-sustaining devices would be required to submit data to the GUDID within 2 years of the date FDA publishes a final rule. FDA noted that the amendment to the proposed rule has not extended the proposed rule’s comment period, which closed on November 7, 2012.