FDA is seeking comments from interested parties for its recently published draft guidance "Custom Device Exemptions."  By the way of background, the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) modified the Food, Drug and Cosmetic Act, by allowing custom device products to be exempted from certain performance standards or premarket approval requirement.

Custom devices are those that are modified or created in order to comply with the order of an individual practioner or meet specific needs of a patient and are usually not available in the U.S. They typically fall into two separate categories, patient-centric and physician/dentist-centric products. Under the draft guidance, if a desired modification of a device is already available in commerce, such modifications would not qualify the device as a custom device. Therefore, appropriate market research is advisable before pursuing the exemption.

The following are some of the highlights:

  1.  A device that is currently being studied or capable of study under an Investigational Device Exemption does not meet the definition of a custom device, but they may qualify for compassionate use.
  2. Custom devices are exempt from Premarket Approval requirements and conformance to mandatory performance standards. However, they are not exempt from the Quality System Regulation, Medical Device Reporting, Corrections and Removals and Registration and Listing.
  3. An existing 510(k) cleared device may be viewed as custom made if the device is modified to treat a unique pathology or unique physiological condition, which render it incapable of clinical study.
  4. The manufacturers of such product require to annually notify FDA, as required by section 520(b)(2)(C), regarding the custom devices they supply.
  5. A manufacturer can make no more than five units of custom devices per year that would remain in possession of the ordering physician and/or the patient.

The deadline to submit comments is March 17, 2014.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.