FDA Drafts List of Device Accessories to be Reclassified into Class I

On Thursday, August 16^th, the FDA released a list of medical device accessories that have the potential to be reclassified as class I devices.

Background

According to section 513 of the Food, Drug, & Cosmetic (FD&C) Act, medical devices are organized into three categories.  Device classification depends on intended use and is based on the amount of risk associated with the device, and therefore, the level of regulatory control necessary to provide reasonable assurance of its safety and effectiveness.  The three classes include:

1. Class I (low to moderate risk) – General Controls
2. Class II (moderate to high risk) – General Controls & Special Controls
3. Class III (high risk) – General Controls & Premarket Approval

The regulatory requirements vary based on the devices classification.  As device class increases from Class I to Class III, the associated risk and thus the regulatory controls also increase; Class I devices have the least amount of risk and thus the are subject to the least regulatory control, and Class III are the highest risk and have the most rigorous regulatory control.

However, the classification, and therefore level of regulation, may be changing for some aspects of some medical devices.  Late last week, the FDA announced that certain Class II and III medical devices may have accessories suitable for reclassification into class I if they are considered separately from the parent device.

Consideration Factors

According to the recent Federal Register notice, “the classification of each accessory will be 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.”

A medical device accessory is considered eligible for a reclassification if:

• It is not used to support or sustain human life, or of substantial importance in preventing impairment to human health
• It does not represent a potential unreasonable risk of illness or injury
• General controls alone would be sufficient to provide reasonable assurance of safety and effectiveness for the accessory

FDA believes that reclassifying certain medical device accessories into Class I will reduce regulatory burden and allow the Agency to focus on other products that post a greater risk.

A full list of proposed accessories for reclassification can be found in the recent notice. FDA is seeking public comment on the recently publication list until Tuesday, October 16, 2018.

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