Silver Spring, July, 2017. The FDA exempted or partially exempted (with specified exceptions) 1003 Class II medical devices from 510(k) premarket clearance regulations – which, contrary to popular belief, had nothing to do with President Donald J. Trump – but instead, as part of its obligations under the 21st Century Cures Act, totally thanks to President Obama and the 114th Congress late last year. Included in the list of products with partial exemption are ‘pee in the cup’ drug tests – the exemption being when indicated for employment screening (when indicated for use by law enforcement, the tests still require 510(k) clearance) – to complex instrumentation including Mass Spectrometers for Clinical Multiplex Testing. According to the Agency, the products on the list, which originally were proposed for exemption earlier in March, are considered “sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness.” FDA took the action “in an effort to decrease regulatory burdens on the medical device industry and reduce private costs and expenditures required to comply with federal regulation.”
Although eventually this should reduce regulatory oversight in the USA for these products, according to the announcement, the Agency actually created a ‘Twilight Zone’ of sorts – as there are manufacturers who paid the user fee for and with 510(k) reviews for these products underway, manufacturers who have products with indications that are now exempt, and not exempt that need to make decisions about whether or not the 510(k) clearance is worth it, and last but in no way least, companies who went through the UDI labeling conundrum and associated products with a 510(k), which may now be exempt and need to adjust the GUDID under 21 CFR 830. Quite the conundrum.
For a complimentary copy of the announcement, click here. For the complete list of exempt and partially exempt devices, click here. If your device is on the list and you would like a no-cost no-obligation preliminary review of your options, be sure to email us here and tick Clearances and Approvals.