510(k) clearance claim on medical device product packaging

B

Benson L

Registered
#1
#1
Hello all.

If a medical device is 510(k) cleared, will it be possible to stay 510(k) cleared claim on the packaging of the product? Or this is a misbranding issue?

Thank you.
 
R

Ronen E

Problem Solver
Staff member
Super Moderator
#2
#2
It's not misbranding as long as you're 100% factual. Remember that "510k clearance" is factually a SE determination - no more, no less.

The FDA is not fond of manufacturers trying to leverage their regulatory position for marketing gain. Specifically, they might come down hard on you if you try to hint or suggest that the device is in any way "approved by the FDA" (unless you have a PMA, which is exactly that - approval).
 
B

Benson L

Registered
#3
#3
Ronen E said:
It's not misbranding as long as you're 100% factual. Remember that "510k clearance" is factually a SE determination - no more, no less.

The FDA is not fond of manufacturers trying to leverage their regulatory position for marketing gain. Specifically, they might come down hard on you if you try to hint or suggest that the device is in any way "approved by the FDA" (unless you have a PMA, which is exactly that - approval).
Click to expand...
Thank you for your reply!!

I am a bit concern with the FDA cleared claims on the product packaging (we a have a product with 510(k) clearance). As I couldn’t find a specific statement that mention FDA cleared statement is forbidden to use.
Meanwhile, for example with 3M mask product, their products didn’t show any FDA cleared claims on their packaging even they are FDA cleared.
 
C

craiglab

Involved In Discussions
#7
#7
Be careful. Good ad & pro practice is not to go there. Read 21 CFR 820.807 "Any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding." And I only supply substantial equivalence letters in response to hospital inquiries.
 
Last edited:
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
F Replacement Bone Screws - Traditional 510(k) or Special 510(k)? Other US Medical Device Regulations 7
Marcelo Antunes FDA News US FDA – November 2018 510(k) Clearances Medical Device and FDA Regulations and Standards News 0
R Distribution of a Device by another company - Questions about 510 (K) Clearance US Food and Drug Administration (FDA) 6
B 510K Clearance Application 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
W Can a CSA-US certificate substitute a FDA 510(k) clearance? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3

Similar threads


Top Bottom