On January 14, 2014, FDA announced the availability of a draft guidance entitled “Custom Device Exemption.”  FDA requests that parties submit comments within 60 days of publication (by March 15, 2014).

Custom devices are exempt from the premarket review requirements and performance standards under FDCA sections 514 and 515, but they are not exempt from any other requirements, including Quality System Regulation, Medical Device Reporting, Corrections and Removals, and Registration and Listing.  These devices can be either patient-focused, meaning designed to treat a unique pathology or physiological condition that no other device is domestically available to treat, or physician/dentist-focused, meaning intended to meet the practitioner’s special needs in the course of professional practice.

As discussed in our client alert, section 617 of FDASIA amended the statutory requirements for custom devices at FDCA section 520(b).  Now, the “production of such device . . . is limited to no more than 5 units per year of a particular device type.”  In addition, manufacturers of custom devices must notify FDA on an annual basis of the manufacture of the device.  FDA’s recently issued draft guidance, also a requirement under FDASIA, sheds some light on these new requirements.

No More Than Five Units Per Year of a Device Type

In the draft guidance, FDA states that it interprets the five unit limitation to mean five new custom device cases per year.  This means that a custom device will not be counted against a subsequent five units per year count if it is later revised or serviced, provided that the revision or servicing is performed in furtherance of meeting the special needs of the person, physician, or dentist for whom the custom device was initially intended.

Manufacturers may provide multiple units for a unique case for sizing concerns.  The unused units will not be counted in the five per year tally, so long as they are returned to the manufacturer and not redistributed.  FDA recommends that the extra units be destroyed and a signed record of destruction maintained.  This means manufacturers must be diligent about having any extra units returned to prevent them from counting against their annual five unit total.

FDA will consider multiple devices of the same type used for one patient requiring treatment of multiple anatomical locations within a given reporting year to count as one unit of the five, provided that any unused devices are returned.  FDA provides the example that if valid bilateral custom joint replacement devices (such as might occur in bilateral knee replacement procedures) are required for a given patient, so long as the patient’s joint replacement procedures occur in the same reporting year, and all unused product is returned to the manufacturer, FDA will consider the multiple joint replacement devices needed to treat the bilateral patient as a single unit in the tally of five units per year of a device type.  This is not the case if treatment of the patient’s multiple anatomical locations occurs during different reporting years.

Compassionate Use

Citing its 1998 Guidance on IDE Policies and Procedures, FDA notes that devices that do not meet all the elements of the custom device definition may still qualify for compassionate use.  Compassionate use of an unapproved device may occur when a device that is being tested in a clinical trial under IDE is the only option available for a patient faced with a serious condition.  All compassionate uses require prior FDA approval before use.  The draft guidance states that sponsors should submit an IDE supplement requesting approval for a protocol deviation in order to treat the patient.  If there is no approved IDE for the device, the sponsor should contact FDA about possible compassionate use.

Annual Reporting

The draft guidance sets forth information that should appear in manufacturers’ annual reports, including a cover letter, certification statement (copy appearing in Appendix II of the draft guidance), and specifics to include on the custom devices manufactured.

Each annual report should cover a given calendar year, with the first report containing retrospective information on custom devices from the date of enactment of FDASIA (July 9, 2012) to the date of the first report.  Subsequent reports should be submitted within the first quarter of the following calendar year.  FDA states that it will not enforce the new annual reporting requirement until the end of the calendar year following publication of the final guidance, but the agency encourages manufacturers to submit information in any format before the guidance is finalized.