By James Gianoutsos, RIMSYS Regulatory Management Software
On Dec. 20, 2017, the FDA issued Medical Device Accessories – Describing Accessories and Classification Pathways: Guidance for Industry and Food and Drug Administration Staff, which applies to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) for combination products.
The guidance document offers welcomed clarity on the role of an “accessory” and its regulatory relationship to its parent device. As always, guidance documents are not legally enforceable; rather, they describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
The guidance explains which devices FDA generally considers “accessories” and describes the processes under Section 513(f)(6) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow requests for risk- and regulatory control-based classification of accessories. In other words, it specifically details what is and is not an accessory, as well as the regulatory routes to classification.
The updated guidance was derived from an August 2017 amendment to section 513(f) of the FD&C Act (FDA Reauthorization Act of 2017 (Pub. L. 115-52)) to state that “the Secretary shall … classify an accessory under [section 513] based on the risks of the accessory when used as intended and the level of regulatory controls necessary to provide a reasonable assurance of safety and effectiveness of the accessory, notwithstanding the classification of any other device with which such accessory is intended to be used.”
The amendment allows for some accessories to have a lower risk profile than that of their parent device and, therefore, may warrant being regulated in a lower class. As classifications for accessories are now risk-based, it provides manufacturers with regulatory flexibility to loosen some of the regulatory burdens on accessories that may not have the same risk profile as their parent devices.
For example, an accessory to a class III parent device may pose lower risk that could be mitigated through general controls, or a combination of general and special controls, and thus could be regulated as class I or class II. A common example of this would be a ventilation system (parent device) with a face mask (accessory).
Additionally, the guidance details the applicable definitions within Section IV: Definitions:
- Accessory — “A finished device that is intended to support, supplement, and/or augment the performance of one or more parent devices.”
- Component (21 CFR 820.3(c)) — “[A]ny raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.”
- Finished Device (21 CFR 820.3(l)) — “[A]ny device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.”
- Parent Device — “A finished device whose performance is supported, supplemented, and/or augmented by one or more accessories.”
Accessory Classification Policy
The risks of an accessory are the risks it presents when used with the corresponding parent device as intended. To classify an accessory, FDA addresses the following two questions:
- Is the article an accessory? This can be answered by determining the intended use of the accessory. Is it intended for use with one or more parent devices, and does it support, supplement, and/or augment the performance of one or more parent devices?
- What is the risk of the accessory when used as intended with the parent device(s), and what regulatory controls are necessary to provide a reasonable assurance of its safety and effectiveness? This can be answered by providing a detailed risk assessment, outlining the potential hazards and reasonable regulatory and quality controls necessary to assure the accessory’s safety and effectiveness.
Individual accessories may be classified pursuant to the same regulation as a corresponding parent device, when appropriate, or be regulated independently.
Once an accessory has been classified, there is another consideration manufacturers need to decide: the Unique Device Identifier (UDI) rule. Not only does your parent device need to have a UDI, but any and all accessories each need to be assigned a UDI.
As 21 CFR 801 Labeling, Subpart B, Section 801.20(a) states: “(1) The label of every medical device shall bear a unique device identifier (UDI) that meets the requirements of this subpart and part 830 of this chapter,” and “(2) Every device package shall bear a UDI that meets the requirements of this subpart and part 830 of this chapter.”
Further, 21 CFR 830 UDI, Subpart A, Section 830.3 defines “finished device” and “device package” as follows:
- Finished device* means any device or accessory to any device that is suitable for use or capable of functioning.
- Device package means a package that contains a fixed quantity of a particular version or model of a device.
*Note that, although “medical device” and “finished device” are not consistent terminology used within the chapters, the terms are one and the same.
In short, any sellable finished device must bear a UDI, either on the device itself, on the device package, or both. Components to the finished device (i.e., service components and spare parts kits) are not considered accessories, and therefore are not required to bear a UDI.
What Does this Ultimately Mean for Manufacturers?
If there was any confusion as to whether a specific accessory is classified as a medical device, it has now been clarified, or at least partially clarified, depending on your specific situation. If there is still confusion among your engineering and regulatory teams, FDA recommends contacting them, via the accessory classification process outlined in the guidance, to classify the accessory appropriately. FDA will treat each accessory classification request as a Q-Submission. Requests may be for a new accessory type (new classification), an existing accessory type (reclassification), or classification of a new accessory type through the de novo process.
A gap analysis should be performed to identify a thorough and complete list of your current and future accessories to determine applicability to the guidance document. Justification also should be documented, should an accessory not apply to the guidance document. Additionally, internal procedures and the process associated with assigning UDIs may need to be updated to ensure there are no compliance gaps.
About The Author
James W. Gianoutsos is a quality assurance and regulatory affairs professional and is founder and president of RIMSYS, a medical device regulatory management software company. James has a diverse background in the medical device, pharmaceutical, and biologics industry, with experience in the design, premarket approval, clinical trials, manufacturing, distribution, and post-market surveillance of drug products and class I, II, and III devices. James has experience establishing and maintaining quality management systems in accordance with FDA, ISO, cGMP, MDD, CMDCAS requirements and standards, and has helped develop and submit multiple regulatory filings, including PMAs, 510(k)s, Design Dossiers, Technical Files, and INDs. James holds a bachelor’s degree in operations management and an MBA from the University of Pittsburgh. He can be reached at firstname.lastname@example.org or 412-567-8428.