FDA has issued a finalized guidance outlining the agency’s approach to classifying and regulating medical device accessories. While remaining consistent with the 2015 draft guidance in many respects, the finalized guidance clarifies the scope of the policy following the passage of the 21st Century Cures Act and describes in greater detail how manufacturers may obtain classification of a new accessory type via the de novo process.
Medical device accessories are products used in tandem with other medical devices, known as “parent devices,” but are sometimes (not always) regulated as separate devices. As defined by FDA, a medical accessory is designed to “support, supplement, and/or augment the performance of one or more parent devices.”
Medical devices are classified according to the levels of risk that the device may cause during its intended function, but there has been some confusion as to whether accessories should be subject to the same classification as their parent devices. In 2015, FDA released draft guidance to clarify some of these ambiguities.
Furthermore, policy provisions in the 21st Century Cures Act passed by Congress in December have amended the Federal Food, Drug and Cosmetic Act (FDC Act) to state that the “secretary shall classify an accessory…based on the intended use of the accessory, notwithstanding the classification of any other device which such accessory is intended to be used.”
Consistent with the draft and new legislation, FDA notes in the finalized guidance that devices will no longer automatically fall into the same classifications as parent devices, and describes a shift in policy that will allow manufacturers greater flexibility when seeking reclassification for accessory types currently on the market.
FDA further stipulated that software products meeting the definition of accessory — including software as a medical device (SaMD), as defined by the International Medical Device Regulators Forum — will now be subject to FDA’s risk-based classification paradigm, as described in the guidance.
The guidance also encourages manufacturers to seek de novo clearance for new types of accessories, a process that would allow the FDA to determine the products’ risk profile independently of the parent device(s). Products eligible for this process should not be previously classified or subject of any approved pre-market approvals (PMAs). These applications should include detailed description of the accessory and the manufacturers reasoning for recommended classification.
Previous policy slowed marketing of many accessories because products were subject to regulation according to a risk classification that was incorrect and unnecessary, stated legal consultants from Hogan Lovells in a blog post. FDA’s new approach would significantly speed up the regulatory process for some devices and reduce unnecessary financial burdens on manufacturers.
“In the face of continuing technological innovation, particularly in the digital health space, the finalized policy should facilitate the marketing of certain accessories that, while use with high-risk devices, may themselves present a lower risk profile,” wrote the consultants.