FDA's Technical Amendment Revises Definition Of Custom Device
FDA has issued a technical amendment to an existing guidance, revising the agency’s definition and criteria for “custom” devices, which are exempt from 510(k) and premarket approval (PMA). These new provisions reflect changes to regulatory definition set forth in recent amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) under 2012’s Food and Drug Administration Safety and Innovation Act (FDASIA).
FDA has been working for four years to accomplish requirements of the FDASIA on a prioritized basis, working with available resources. FDASIA, which expanded the FDA’s authority and contained measures to improve stakeholder involvement and the agency’s ability to expedite innovative technology, reformed the FD&C’s existing definition of custom devices as part of its “medical device regulatory improvements” section.
Custom devices are similar to approved devices but custom-made, based on the individual needs of a patient as determined by a medical professional. In these cases, FDA does not require manufacturers to submit applications for each individualized device, provided the manufacturer meets the standards for good manufacturing practices (GMPs). According to the Regulatory Affairs Professionals Society (RAPS), a court case in 2009 “left unanswered questions” about how to define “custom,” and the issue was addressed in FDASIA.
In 2014, FDA released a final guidance explaining statutory provisions for custom device exemptions and additional explanations based on comments the agency received. The recently released final rule is intended to “correct the regulations by revising the definition of a custom device to restate the statute,” and to formally amend section 520(b) of the FD&C, said FDA.
Under the new provisions: Devices defined as “custom” 1) are manufactured to comply with the order of an individual doctor or dentist, 2) “necessarily deviate” from performance standard of the approved version of the device in order to comply with the doctor’s order 3) are not “generally available” in the U.S. in finished form, 4) are designed for a condition no other commercially available device is domestically available to treat, 5) are intended to meet the special needs of a physician 6) are “assembled on a case-by-case basis” for individual patients and 7) “may have common, standardized design characteristics” as commercially distributed devices.
FDA’s final ruling also included clarification for devices intended to treat “sufficiently rare conditions” where a clinical trial would not be practical. Manufacturers of these devices may produce no more than 5 per year and must submit annual reports to FDA on the custom devices provided.
“This technical amendment to the regulations for the custom device exemption will ensure clarity and consistency with the requirements of the FD&C Act,” said the FDA in its final rule. “Some manufacturers might be unaware that certain medical devices that they distribute as custom devices do not meet the statutory definition as currently described in the regulations and are subject to premarket review.”
Industry stakeholders will not have the opportunity to comment on the amendment, and FDA commented that notice-and-comment procedures “were unnecessary” because the regulations “merely restate the statute they implement.”
Earlier this year, FDA released a draft guidance for 3D-printed medical devices based on a 2014 public workshop hosted by the agency.