The FDA issued Medical Device Accessories –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.
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 medical device accessories.
The updated guidance was derived from an August 2017 amendment to section 513(f) of the FD&C Act (FDA Reauthorization Act of 2017.
The amendment allows for some accessories to have a lower risk profile than that of their parent device. As classifications for accessories are now risk-based, it provides manufacturers with the 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).
Guidance details within Section IV are mentioned below:
- 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)) — “Any 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)) — “Any 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.
Once Medical Device Accessories are 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 Part 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.
What Does this Ultimately Mean for Manufacturers?
A gap analysis should be performed to identify a thorough and complete list of your current and future medical device 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.