FDA issues draft updated recommendations on submitting a new 510(k) for device modifications

Interesting news coming out of the FDA today, where the agency released a rule that amends its regulations on the definition of a custom device so as to include new statutory requirements under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA).

With this updated revision, a device that meets the qualification of a custom device is now exempt from 510(k) and Premarket Approval (PMA) submissions.

The FDA is saying with this ruling that the new definition of a "custom device" will ensure clarity and consistency among manufacturers who may not be fully aware that some devices do not meet the original definition. Many of these are, and have been, subject to premarket review.

A device will qualify as a “custom device,” FDA says, by meeting new statutory requirements, including, among others, that each device:

  1. Is created or modified in order to comply with the order of an individual physician or dentist (or other specially qualified person);
  2. Necessarily deviates from an otherwise applicable performance standard under section 514 or requirement under section 515 of the FD&C Act;
  3. Is not generally available in the US in finished form through labeling or advertising by the manufacturer, importer or distributor for commercial distribution;
  4. Is designed to treat a unique pathology or physiological condition that no other device is domestically available to treat;
  5. Either (a) is intended to meet the special needs of such physician or dentist in the course of the professional practice of such physician or dentist or (b) is intended for use by an individual patient named in the order of a physician or dentist (or other specially qualified person as designated);
  6. Is assembled from components or manufactured and finished on a case-by-case basis to accommodate the unique needs of individuals, physician or dentist;
  7. May have common, standardized design characteristics, chemical and material compositions and manufacturing processes as commercially distributed devices.
While we await final documentation, you can read more about the FDA's ruling here.