FDA Issues New Draft Guidance for Custom Devices; Some Points Worth Highlighting

By Jeffrey K. Shapiro –

FDA has issued a new draft guidance on the custom device exemption.  Comments are due by March 17, 2014.  This schedule puts FDA on track to finalize the guidance by July 9, 2014, as required under section 617 of the Food and Drug Administration Safety and Innovation Act (“FDASIA”) (Pub. L. 112-144).  (See our FDASIA summary here at pages 41-42.)

What is the custom device exemption?  It is a long standing provision in Section 520(b) of the Federal Food, Drug, and Cosmetic Act (“FDCA”) that allows device manufacturers to distribute devices designed to accommodate unique  patient conditions without premarket application (“PMA”) approval under Section 515 of the FDCA.  The exemption does not relieve the manufacturer of the usual post market regulatory requirements that apply to medical devices.

Congress revamped the custom device exemption in FDASIA.  Some of the changes were more clarifying than substantive, but a few new concepts were added.  Those who need to consider the applicability of a custom device exemption should review the amended statute and draft guidance and ignore the existing regulation (21 C.F.R. § 812.3(b)), which has not been updated. 

The following is a paraphrase of the custom device requirements in the revised statute.  For a device to qualify, all of these requirements must be met:

• It is created or modified to comply with the order of a physician or dentist.
• In order to comply, the device necessarily deviates from an otherwise applicable premarket approval requirement in Section 515 of the FDCA.
• It is not generally available in finished form through labeling or advertising for commercial distribution in the U.S.
• It is designed to treat a unique pathology or physiological condition that no domestically available device can treat.
• It is intended to meet the needs of a physician or dentist in treating a patient, or will be used by the patient on order of the physician or dentist.
• It is assembled by components or manufactured and finished on a case by case basis to accommodate the unique needs of the physician/dentist or patient.
• It may have common standardized design characteristics, material and chemical composition, and manufacturing processes as commercially distributed devices.

If a device meets these requirements it may be distributed as a custom device, with three further limitations:

• The condition being treated must be sufficiently rare that a clinical study is impractical.  (This limitations codifies an interpretation that FDA has long applied.)
• Multiple units of the device may qualify for the exemption, but no more than five units per year.
• The manufacturer must annually notify FDA if it is producing custom devices.

FDA’s guidance does a good job of explaining how the agency will enforce these requirements.  We will not reiterate the entire guidance here, since it is largely self explanatory.  The flow chart on page 19 of the draft guidance is especially useful. 

A few points are worth highlighting:

• FDA interprets the five unit per year limitation to exclude extra devices provided in different sizes if the unused devices are returned.  Also, multiple devices for multiple anatomical locations (e.g., bilateral hip replacements) will count as one unit if used in the same reporting year.  [Draft Guidance, lines 229 264.]
• FDA explains that the a device is either patient-centric or physician/dentist centric.  The distinction is between a device that treats a rare patient need and leaves the practice with the patient versus a device that fulfills a special need in the physician/dentist practice that stays with the practice.  [Draft Guidance, lines 279 285.]  It is left unexplained what types of devices might fulfill a physician/dentist special practice need.  It would have been helpful if examples had been provided; all of the examples appear to relate to patient needs.
• FDA reiterates its long standing interpretation precluding “patient specific” or “patient matched” devices from qualifying for the custom device exemption.  These are devices “in which ranges of different specifications have been approved or cleared to treat patient populations that can be studied clinically. . . .  The final manufacturing of these devices can be delayed until the physician provides imaging data or other information . . . to finalize the specifications of the device within . . . cleared or approved ranges. As a result, the device is specifically tailored for the patient.”  [Draft Guidance, lines 329 343.]  Thus, contact lenses or customizable orthopedic implants would typically not qualify for the custom device exemption. 

A final stylistic point: the draft guidance continues FDA’s increasing practice of providing guidance through lengthy question and answer sections.  This practice is somewhat helpful in ensuring that specific questions are answered.  But the use of lengthy questions in headings and subheadings makes it more difficult to find information, not less so.  FDA should revert to using key word topic headings and subheadings; these are a tried and true way of showing the reader where information may be found.