FDA Exempts 120 Medical Device Types from Most Regulation

The US Food and Drug Administration (FDA) plans to exempt 120 medical device classes from its premarket notification and review requirements, making it substantially easier for companies to market the devices.

Background

Under existing regulations, FDA regulates devices according to three general categories:

• Class III – High-risk devices; require the submission of a Premarket Application (PMA).
• Class II – Moderate-risk devices; require the submission of a Premarket Notification Application (510(k)); must either show substantial equivalence to an existing device or compliance with established "special" controls.
• Class I – Low-risk devices; exempt from premarket notification; must meet "general" controls.

Having a device regulated as a lower-risk product is advantageous for companies, as it allows them to avoid costly user fees, lengthy regulatory review times and many of the costs associated with developing a product.

For example, consider the cost to submit a Class III device using a PMA in 2015: $250,895. In comparison, a Class I device exempt from submitting a 510(k) would cost the company nothing to submit. Another benefit: A Class I device requires no fee to market each year, whereas a Class III device must pay $8,781 to FDA each year to remain on the market.

Even a 510(k) is somewhat expensive--$5,018 per application, though most of its true costs come from obtaining the data necessary to show its equivalence to existing devices or adherence to established standards.

Regulatory Exemptions

Clearly, then, medical device companies like it when their devices are subject to lesser amounts of regulation. It means they can bring their products to market more quickly and with less of an up-front investment in resources. The issue received prominent attention in 2012 under the third reauthorization of the Medical Device User Fee Act (MDUFA), when FDA committed to proposing "additional low risk medical devices to exempt from premarket notification" by the end of Fiscal Year 2013.

"Within two years of such proposal, FDA intends to issue a final rule exempting additional low risk medical devices from premarket notification," it wrote.

Now FDA is signaling its intent to exempt many devices from premarket notification requirements.

"The FDA believes devices identified … are sufficiently well understood and do not require premarket notification (510(k)) to assure their safety and effectiveness," it wrote in its new final guidance document, Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements.

While FDA intends to eventually exempt these devices from premarket notification through the notice and rulemaking process, it says it will not "enforce compliance with 510(k) requirements" in the meantime, and will not require companies to submit a 510(k).

The exempt devices are as follows:

Federal Register / Guidance