Accessories to medical devices, what are they and how does FDA regulate them? FDA released a draft guidance document to address just this question. As with all draft guidance’s, it is currently open for comment, details on how to submit comments are provided at the end of this update.
FDA defines an accessory to be a device that is intended to support, supplement, and/or augment the performance of one or more parent devices. The policy governing the classification of accessories is subject to the same risk- and regulatory control-based scheme that FDA uses to classify all medical devices. The risks of an accessory are the risks that it presents when used with the corresponding parent device as intended. In order to classify an accessory, FDA addresses the following two questions:
- Is the article an accessory?
- What is the risk of the accessory when used as intended and what level of regulatory controls are necessary to provide a reasonable assurance of its safety and effectiveness?
The answers to these two questions inform the risk- and regulatory control-based classification of a potential accessory pursuant to the criteria at Section 513(a)(1) of the FD&C Act. Individual accessories may either be classified pursuant to the same regulation of a corresponding parent device or be regulated independently.
FDA encourages manufacturers to utilize the de novo classification process in Section 513(f)(2) of the FD&C Act to request risk-based classifications of new types of accessories. This process provides a pathway to Class I or Class II classification for accessories for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness, but for which there are no legally marketed predicate device. If the de novo is declined, the accessory remains in Class III and may not be marketed.
The draft guidance can be found at Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types; Draft Guidance for Industry and Food and Drug Administration Staff.
Comments and suggestions regarding this draft document can be submitted within 90 days of publication in the Federal Register (Jan 20, 2015) of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to regulations.gov.
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