The recent reclassification of blood lancets by the FDA may or may not have caught you by surprise.
To bring you up to speed, blood lancets are now classified as Class II and Class III devices and require a 510(k) or premarket approval submission.
All manufacturers of blood lancets now have less than 𝟯𝟲𝟱 𝗱𝗮𝘆𝘀 𝘁𝗼 𝘀𝘂𝗯𝗺𝗶𝘁 𝗮 𝟱𝟭𝟬𝗸 𝗼𝗿 𝗣𝗠𝗔 for their devices, as the new ruling goes into effect November 22, 2022.
Yup, you read that correctly. Less than one year to get FDA approval or clearance for a lancet already on the market.
Single-Use Lancets have been reclassified as Class II devices and require a 510(k).
Multiple-Use Lancets have been reclassified as Class III and require premarket approval (PMA).
And if you are developing a new lancet, then you will need to submit a full 510(k) or PMA in order to bring it to market.
Think of this reclassification of blood lancets as an early gift from the FDA. One that you probably wish was still stuck on a container ship outside the port of Los Angeles along with all the other 2021 holiday gifts. 😕
But fear not – the leanRAQA team can help. We can help you determine the best pathway for your lancet, then help you put your submission together – we might even convince you that regulatory submissions can be fun.
Or maybe not. But at least you’d be able to keep your lancet on the market.
Curious about the correct FDA pathway for your device? Check us out on YouTube for more regulatory goodness.