510(k) usage - Company has 2 physically similar products

Zumey

Registered
#1
Hi everyone.

There's this situation where a company has 2 physically similar products, a normal and advanced one. The advanced one has 510k number but not the normal one. However, the client wants to import the normal one to USA. Can the company use the advanced's 510k number? The material and intended purpose are the same. It's just the advanced one was safe from a more hazardous chemical.

Thank you
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
It's just the advanced one was safe from a more hazardous chemical.
How is this increase in safety achieved?
Is that the only tech difference?

In principle you can't use a 510(k) for a device that's considered as not coming under the cleared scope. To determine whether that is or isn't the case, full details of the device in question and the cleared 510(k) submission are required. Otherwise it's just a guesstimate.
 
#3
How is this increase in safety achieved?
Is that the only tech difference?

In principle you can't use a 510(k) for a device that's considered as not coming under the cleared scope. To determine whether that is or isn't the case, full details of the device in question and the cleared 510(k) submission are required. Otherwise it's just a guesstimate.
Sir, there's confusion in my question and I apologize for that. The products are the same. They have same colour, specifications, physical dimensions but different labeling. This is due to the advanced one has been tested with dangerous substance so it has additional label, compared to the normal one. As far as I've read, only document to file needed because there is no change in safety. What's your opinion?
 
Thread starter Similar threads Forum Replies Date
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 5
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
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 14
K Changing the Address in 510(K) Approved Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K Completing Design Controls after 510(k) Clearance Other US Medical Device Regulations 11
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) 15
F Replacement Bone Screws - Traditional 510(k) or Special 510(k)? Other US Medical Device Regulations 7
M Informational US FDA Final guidance – Metal Expandable Biliary Stents – Premarket Notification (510(k)) Submissions Medical Device and FDA Regulations and Standards News 0
Watchcat Informational FDA Proposal to "Modernize" the 510(k) - 2019 Other US Medical Device Regulations 1
B 510(k) clearance claim on medical device product packaging Other US Medical Device Regulations 6
shimonv Referring to previously submitted biocompatibility results in a new 510(k) submission Other US Medical Device Regulations 1
L A Taiwan company want to sell Class I medical device (510(k) exempt) on Amazon, should we register with FDA? US Food and Drug Administration (FDA) 4
B Submit a 510(k) with a Predicate cleared but not Listed US Food and Drug Administration (FDA) 9
R 510(k) Biocompatibility vs Cleaning Validation Other Medical Device Related Standards 4
K Change of Existing Medical Devices and 510(k) US Food and Drug Administration (FDA) 9
S Where did FDA 510(K) form 3654 go? Other US Medical Device Regulations 1
M Has anyone here assessed the latest Abbreviated 510(K) guidance document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Informational USFDA – Refuse to Accept Policy for 510(k)s Medical Device and FDA Regulations and Standards News 1
K 510(k) expanding the indication for use for a cleared device Other US Medical Device Regulations 9
P 510(k) cleared, Rx only and home use 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
lilybef Number of lots required for stability testing of a Class II device in the 510(k) Qualification and Validation (including 21 CFR Part 11) 3
T Executive summary for Traditional 510(k) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
M FDA News US FDA – November 2018 510(k) Clearances Medical Device and FDA Regulations and Standards News 0
M FDA News FDA Report - FDA Has Taken Steps to Strengthen The 510(k) Program Other US Medical Device Regulations 0
M Medical Device News FDA - Transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices Other US Medical Device Regulations 0

Similar threads

Top Bottom