Earlier this month, the US FDA updated its definition of a custom medical to include new statutory requirements for custom devices 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).
By nature, custom medical devices are similar to traditionally approved medical devices except that they have been designed and manufactured for the needs of a specific individual following assessment by a healthcare practitioner. Furthermore, under existing provisions, a device that meets the requirements of a custom medical device is exempt from submitting both 510(k) and PMA applications to the FDA.
The updated definition amends a 2014 guidance document issued by the FDA that explained and defined several requirements and provided answers to a variety of anticipated industry questions in a hope to make clearer, the practical implications on the commercial activities of those companies producing custom medical devices.
However, in that time it became apparent to the FDA that some manufacturers, whether inadvertent or not, were distributing certain medical devices as custom devices even though they did not meet the statutory definition as described in the regulations. Therefore, the FDA issued this updated definition to further clarify the applicable requirements in an effort to assist manufacturers complying with them consistently across the industry.
Under the new requirements, a device will be considered a custom device if it meets the following for each device:
- is created or modified in order to comply with the order of an individual physician or dentist (or other specially qualified person);
- necessarily deviates from an otherwise applicable performance standard under section 514 or requirement under section 515 of the FD&C Act;
- is not generally available in the United States in finished form through labeling or advertising by the manufacturer, importer, or distributor for commercial distribution;
- is designed to treat a unique pathology or physiological condition that no other device is domestically available to treat; either
- 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 other specially qualified person as designated) in the course of their professional practice or
- is intended for use by an individual patient named in the order of a physician or dentist (or other specially qualified person as designated);
- is assembled from components or manufactured and finished on a case-by-case basis to accommodate the unique needs of individuals, physician, or dentist; and
- may have common, standardized design characteristics, chemical and material compositions, and manufacturing processes as commercially distributed devices.
While these include only minor changes from the existing requirements outlined in the 2014 guidance, there are new provisions that will enable manufacturers to more easily determine which of their products are custom devices. These new provisions include:
- the device is for the purpose of treating a sufficiently rare condition, such that conducting clinical investigations on such device would be impractical;
- the production of the device must be limited to no more than five units per year of a particular device type; and
- a manufacturer is required to submit an annual report to FDA on the custom devices it supplied.
The implication for manufacturers is a much clearer framework explaining the statutory requirements for devices distributed as custom devices to allow more informed decision making. From an industry perspective, this updated definition should act to increase the overall compliance and reduce the incidence of manufacturers unaware of the applicable statutory requirements.
This ruling is final and is not open for comments and suggestions for improvement from industry stakeholders.
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