Medical Device Accessories Guidance | Food Drug and Cosmetic Act

PUNE, India - Feb. 25, 2020 - PRLog -- 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 (http://www.operonstrategist.com/regulatory-consultant/) 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."