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FDA Proposes to Apply Risk-Based Framework to Accessory Devices

Written by Ellen Janos

In another effort to bring some clarity to its regulation of devices, the FDA has released draft guidance on how its risk-based framework applies to accessory devices ( the “Draft Guidance”). This development is welcome news for the mHealth community.

What is an accessory?  The Draft Guidance considers an accessory to be an article that is intended for use with one or more parent devices and is intended to support, supplement, and/or augment the performance of one or more parent devices. While accessories were typically included in the same class as the parent device, the FDA now recognizes that some accessories can have a lower risk profile than that of their parent device and may warrant being regulated in a lower class. For these lower risk products, the Draft Guidance encourages the use of the FDA  de novo classification process to request risk-based classification of accessories of a new type.

The FDA is seeking comments on the Draft Guidance by April 15, 2015.

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Karen S. Lovitch

Chair, Health Law and Health Care Enforcement Defense Practices

Karen advises industry clients on regulatory, transactional, operational, and enforcement matters. She has deep experience handling FCA investigations and qui tam litigation for laboratories and diagnostics companies.