SBS - The Best Value in QMS software

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.
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
Ronen E

Ronen E

Problem Solver
Staff member
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.
 
shimonv

shimonv

Trusted Information Resource
#4
#4
Hi Benson,
My advise to you is to put this statement in your promotion material or your website, not on the package.
 
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
K Completing Design Controls after 510(k) Clearance Other US Medical Device Regulations 11
R Distribution of a Device by another company - Questions about 510 (K) Clearance US Food and Drug Administration (FDA) 6
W Can a CSA-US certificate substitute a FDA 510(k) clearance? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
V 510 k submission RTA (Acceptance Checklist ) Other US Medical Device Regulations 5
Watchcat 510(k)s and "Innovation"? Other US Medical Device Regulations 2
D Change to labelling - does it require a new 510(k)? US Food and Drug Administration (FDA) 5
A How can we change a device trade name in 510(k) summary? US Food and Drug Administration (FDA) 0
K PMA vs 510(k) for Mammography Machine US Food and Drug Administration (FDA) 2
S Predicate Material 510(k) US Food and Drug Administration (FDA) 1
S Predicate Material 510(k) Medical Device and FDA Regulations and Standards News 3
J US Device Listing when not the 510(k) owner Medical Device and FDA Regulations and Standards News 2
supadrai Possible to Submit a 510(k) if you have never, do not and cannot produce the device for which you're submitting the application? US Food and Drug Administration (FDA) 4
S Special 510(k) for orthopedic implant 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Label change - 510(k) Medical Device and FDA Regulations and Standards News 5
G We want to add Covid-2 /19 to our air filter 510 K Medical Device and FDA Regulations and Standards News 0
A The refund of 510(k) user fee Medical Device and FDA Regulations and Standards News 0
A Which guidance do you use for guiding the requirements of IFU for 510(k) submission? Medical Device and FDA Regulations and Standards News 5
A 510(k) review timeline 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
L Impact on 510(k) to use an additional manufacture US Food and Drug Administration (FDA) 0
T 510(k) submission - Which name should I use in the submission? Other US Medical Device Regulations 3
Watchcat Advantages to pursuing a Special 510(k) instead of a Traditional 510(k) Other US Medical Device Regulations 5
A 510(k) registration and listing US Food and Drug Administration (FDA) 1
Aymaneh Traditional 510(k) Declaration of Conformity Other Medical Device Regulations World-Wide 3
M Should 510(k) Predicates be Actively Listed Devices? Other US Medical Device Regulations 12
A Several sections of traditional 510(K) have the same or similar requirement of content. US Food and Drug Administration (FDA) 4
A Some questions about voluntary consensus standards in traditional 510(k) submission US Food and Drug Administration (FDA) 6
A Some doubts about traditional 510(k) submission US Food and Drug Administration (FDA) 5
A Bench test report translation to English for 510(k) submission Other US Medical Device Regulations 2
S Special 510(K) - Labeling change from Rx to OTC Other US Medical Device Regulations 11
J 510(k) for a control kit for an external IVD test kit 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Y Expanding the indications for use for a 510(k) cleared device Medical Device and FDA Regulations and Standards News 4
T First 510(k) submission - Class II software as medical device US Food and Drug Administration (FDA) 4
T Submitting MR Compatibility Data for 510(k) Cleared Device Other Medical Device and Orthopedic Related Topics 2
M CE Mark and 510(k) -Global registration requirements for every country Other Medical Device Regulations World-Wide 3
Z 510(k) usage - Company has 2 physically similar products Medical Device and FDA Regulations and Standards News 2
K 510(K) File eCopy Submission 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
Q Need clarification on requirements.... Class i, gmp & 510(k) exempt Medical Device and FDA Regulations and Standards News 12
D Redacted 510(k)s - Example wanted Document Control Systems, Procedures, Forms and Templates 17
K Changing the Address in 510(K) Approved Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
P Predicate Device Information for 510(k) Submission Medical Device and FDA Regulations and Standards News 4
M 510(k) 10993 Biocompability Testing Other US Medical Device Regulations 15
D First 510(k) Submission - Don't Forget Tips US Food and Drug Administration (FDA) 5
K Reporting a Change of Contract Manufacturer for a 510(k) cleared device Other US Medical Device Regulations 5
K Mammography Machine Bench Testing - FDA 510(K) US Food and Drug Administration (FDA) 5
D Is Human Factors testing mandatory for a 510(k) submission? Human Factors and Ergonomics in Engineering 16
D Pre-Submission after 510(K) Submission? Other US Medical Device Regulations 4
M Informational US FDA Final Guidance – Special Premarket Notification [510(k)] Pathway Medical Device and FDA Regulations and Standards News 0
M CBE (Change Being Effected) 510(k) Submission Other US Medical Device Regulations 2
K 510(K) Submission (Traditional) for Medical Device US Food and Drug Administration (FDA) 17
F Replacement Bone Screws - Traditional 510(k) or Special 510(k)? Other US Medical Device Regulations 7

Similar threads

Top Bottom