In the first installment of this series, we discussed Class I device types that are exempt from premarket notification (also known as a 510(k)). I certainly recommend you read that post, but to recap: FDA often requires you submit a 510(k) for medical devices in cases where a premarket approval (PMA) isn't required. The purpose of the 510(k) is to show that the device that is going to be marketed is safe and effective because it is equivalent to a device that is already being legally marketed. FDA occasionally issues exceptions to the types of devices they require to have premarket notification. They make these exceptions essentially because they believe the devices are understood well enough that premarket clearance isn't necessary, and so exempting them will save everyone a bit of time and money:
"The FDA believes that the device types identified in the Federal Register are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness. This action will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with Federal regulation. "
You can read a more about their philosophy behind their exemptions in much more detail here, but that's the gist of it: they really do want things to be as safe and efficient as possible for patients and industry alike.
Last week, FDA released their latest missive on Class II exemptions.
Here's your refresher on the distinction between classes:
"FDA classifies medical devices based on the risks associated with the device. Devices are classified into one of three categories—Class I, Class II, and Class III.
Class I devices are deemed to be low risk and are therefore subject to the least regulatory controls. For example, dental floss is classified as Class I device.
Class II devices are higher risk devices than Class I and require greater regulatory controls to provide reasonable assurance of the device’s safety and effectiveness. For example, condoms are classified as Class II devices.
Class III devices are generally the highest risk devices and are therefore subject to the highest level of regulatory control. Class III devices must typically be approved by FDA before they are marketed. For example, replacement heart valves are classified as Class III devices."
So this time around, with Class II exemptions, we're looking at more complicated things than dental floss. Here's a snapshot of some of the items that are on the "no longer require premarket notification under section 510(k)" list:
Devices that stuck out to me are kelly pads, single use acupuncture needles, and operating room lamps!
We talked recently about how tongue depressors are medical devices, and now here's a lamp as a Class II device! It makes sense, though: operating rooms have to be properly lit to be safe. Lights have to avoid casting shadow, shine deeply into cavities, and render light accurately and naturally. They also need to be safely installed to hang over patients and doctors during sensitive procedures and be able to be sterilized. No small feat.
Single use acupuncture needles are less surprising, as they puncture and enter the body, but I'd bet many people would be surprised to hear that acupuncture uses medical devices. Medical devices are everywhere!
Kelly pads. These inflatable rubber devices are used on postpartum mothers to monitor blood loss and detect hemorrhage.
You can check out more Class II devices that are now exempt from premarket notification. How many do you recognize?
Be sure to keep an eye on FDA's news and information releases: it's always good to check in with them and see how they're staying on top of keeping things safe and efficient. You can sign up for their many and varied newsletters here.