EMERGO SUMMARY OF KEY POINTS:

• US regulators have exempted 71 Class I medical device product codes from 510(k) clearance requirements.
• The new exemptions are limited in scope, primarily affecting manufacturers of analyte control products.

Medical device regulators at the US Food and Drug Administration have identified multiple low-risk devices for exemption from 510(k) premarket notification requirements.

The FDA notice lists 71 Class I device types that no longer require 510(k)s for US market authorization; earlier in 2017, the agency exempted several types of Class II devices from premarket notification requirements, as well. Both actions are part of the FDA’s streamlining efforts mandated by the 21^st Century Cures Act of 2016.

Small number of medical devices actually affected

Although this latest move by the FDA may seem substantial, an Emergo analysis of available FDA 510(k) submission data shows that only 141 devices under the 71 Class I product codes identified for exemption have received 510(k) clearance in the past five years. Of the more than 15,000 devices cleared during that timeframe, these products constitute less than one percent. Furthermore, most of the product codes on the FDA’s new Class I exemption list had no devices cleared in the past five years.

Most of the 141 devices that were cleared under affected Class I product codes in the past five years fall under either code JJX or JJY, which pertain to analyte control products. Thus, manufacturers of analyte controls are most affected by the FDA’s latest round of 510(k) requirement exemptions.

FDA 510(k) resources from Emergo:

• FDA 510(k) consulting services for medical device and IVD companies
• Whitepaper: US FDA 510(k) submission preparation
• Whitepaper: FDA device classification processes