SBS - The best value in QMS software

Licensing of a 510K to another manufacturer

M

ManTheDan88

#1
#1
Hey All,

I have a question concerning the licensing of an 510k to another manufacturer. Manufacturer A owns a 510k and is currently private labeling the 510k device to Manufacturer B. Manufacturer B decides it wants to manufacturer the device themselves under Manufacturer A?s 510k. Is it as simple as Manufacturer A granting Manufacturer B the right to manufacturer the device under their name through a signed agreement? Or would Manufacturer B need to file a new 510k to manufacturer the same device? I look forward to your guidance.

- D
 
12 questions to ask before buying a QMS
Elsmar Forum Sponsor
Michael Malis

Michael Malis

Quite Involved in Discussions
#2
#2
Re: Licensing of a 510K

ManTheDan88 said:
Hey All,

... Manufacturer A owns a 510k and is currently private labeling the 510k device to Manufacturer B. Manufacturer B decides it wants to manufacturer the device themselves under Manufacturer A?s 510k. Is it as simple as Manufacturer A granting Manufacturer B the right to manufacturer the device under their name through a signed agreement? Or would Manufacturer B need to file a new 510k to manufacturer the same device? I look forward to your guidance.

- D
Click to expand...
Manufacturer B need to have their 510(k)! A is private label for B, does not make B a manufacturer. B needs to prove to the agency that their Quality System and Processes are appropriate, so the FDA will provide a clearance for B to produce this product.

I hope this helps,
Michael
 
M

ManTheDan88

#3
#3
Re: Licensing of a 510K

Even if manufacturer B is a FDA registered manufacturing facility and manufacturers a similar product?
 
Michael Malis

Michael Malis

Quite Involved in Discussions
#4
#4
Manufacturing "similar product" does not give you the right to manufacture this product. Again, you need to prove to the agency that you have a system and processes and it is up to the agency to decide...
 
M

MIREGMGR

#5
#5
I don't quite agree with Michael above. The rules in several places say that the maker of a 510(k)-required device must have such a 510(k), and there is no provision in the DLRM website, for instance, for a Lister to explain that the 510(k) they identify by number as applying to their manufacturing activity for a particular Listing is not theirs but they have permission to solely reference it.

But FDA documents also have long discussed the transfer of a 510(k), such as by sale. If a 510(k) can be sold, it must also be able to be leased, i.e. licensed.

We know that FDA's 510(k) database identifies only the original submitter. FDA does not have a role in any subsequent transfers or other transactions, so if you do a Listing and cite a 510(K) that wasn't issued to you, you're volunteering for an inquiry from FDA asking for documentation that you have current ownership of, or exclusive permission to use that 510(k).

The current FDA guidance on 510(k) transfer and related issues is at http://www.fda.gov/downloads/medica...onandguidance/guidancedocuments/ucm427385.pdf.
 
Michael Malis

Michael Malis

Quite Involved in Discussions
#6
#6
MIREGMGR said:
But FDA documents also have long discussed the transfer of a 510(k), such as by sale. If a 510(k) can be sold, it must also be able to be leased, i.e. licensed.
].
Click to expand...
In above correspondence there is no discussion about sale. Yes if A sold product to B, you can TRANSFER 510(k) with sale to the new owner. I am not aware of any other situation when licencing 510(k) is OK.
 
M

MIREGMGR

#7
#7
I think the bottom line is that FDA's guidance regarding 510(k) transfer, or use by a party other than the original submitter, is inadequate. The range of potential scenarios is large, and FDA provides no help as to any of the subtleties.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
N Special Contract Manufacturing or 510k Licensing 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Medical Device News Health Canada update 28-08-18 - Licensing Requirements for 3D-Printed Devices Canada Medical Device Regulations 0
A Medical Device Licensing - Plans or Process Maps Other US Medical Device Regulations 3
M Is an R&D company subject to FDA regulation when licensing and not manufacturing? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
A Medical Device Licensing - We are planning to sell another product Canada Medical Device Regulations 2
J How does CB (Certification Body) 'Licensing' work? Registrars and Notified Bodies 7
V DFARS (Defense Federal Acquisition Regulation Supplement) Licensing? Bulgaria Various Other Specifications, Standards, and related Requirements 14
C Medical Devices and Licensing of Trademark to an OBL in UK EU Medical Device Regulations 6
C USB dongle licensing system for Medical Imaging Software Other Medical Device and Orthopedic Related Topics 1
Q Canadian Licensing to sell Class I and Class II Devices in Canada ISO 13485:2016 - Medical Device Quality Management Systems 2
T Licensing jurisdiction of the US Department of Commerce Various Other Specifications, Standards, and related Requirements 1
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
H 510k with Contract Manufacturer Other US Medical Device Regulations 2
K FDA 510k electrosurgery 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
J Leveraging FDA 510k Clearance for International Registrations Other Medical Device Regulations World-Wide 2
K 510K new manufacturer but same components Other US Medical Device Regulations 6
S Two or more predicates suitable? 510K submission US Food and Drug Administration (FDA) 5
S 510k: What to include if your own device is the predicate US Food and Drug Administration (FDA) 5
L 510K - Trade Name Change 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
Ed Panek Adverse Event Clinical Trial using a 510K approved Device Other US Medical Device Regulations 6
R Countries that accept 510k approvals - Class II nonsterile medical device Other Medical Device Regulations World-Wide 2
M Timing of 510k submission Other US Medical Device Regulations 9
S Examples of software changes that required a 510k US Food and Drug Administration (FDA) 2
D 510K and Changes to Verification and Validation US Food and Drug Administration (FDA) 2
Ronen E Can anyone please explain this? (510k submission requirement) Other US Medical Device Regulations 14
H New 510K VS Documents about design change. Other US Medical Device Regulations 1
P Medical Device not on commercial distribution but installed in the establishment. 510k? Other US Medical Device Regulations 10
V Presubmission FDA for 510k US Food and Drug Administration (FDA) 4
A How to deal with changed shared components in 510k 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N Can we take a part from 510k cleared medical device and use it in class I device? Other US Medical Device Regulations 3
D Contents of a 510k Q submission Other US Medical Device Regulations 1
L Class IIa Medical Device, CE Mark & 510k - Labeling Content CE Marking (Conformité Européene) / CB Scheme 4
Ed Panek Other company wants to use our FDA 510K bundled with their product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
L 510k exemption process - Do you still need to submit technical dossier? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S IEC 62133 - CB Scheme Required by FDA 510k Other Medical Device Related Standards 3
S The key differences in 510k types - Traditional vs. Abbreviated vs. Special US Food and Drug Administration (FDA) 0
P V&V for Special 510k 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Clarity on requirements for a 510k exempt Class I device - Suture removal kit US Food and Drug Administration (FDA) 9
T Is 510k Anesthesia group particularly picky/difficult to work with during 510k? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
J 510k - Product shelf life validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K 510K statement Questions 21 CFR 807.93 - Discontinued or never released for sale US Food and Drug Administration (FDA) 0
J Applying for 510K - What is a significant process change and what is not US Food and Drug Administration (FDA) 5
K 510K Interactive Review 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
I Celsius and Fahrenheit in 510k US Food and Drug Administration (FDA) 4
R FDA 510K - Does the FDA accept the testing report from other countries? Other US Medical Device Regulations 1
I 510k Performance Testing Studies (Raw Data) - What does the FDA expect 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Is a different 510k is required for each (stand alone) software configurations? Other US Medical Device Regulations 3
K ISO 10993 Requirements For 510k - Substantial Equivalence Other US Medical Device Regulations 11
P Two separate 510k submissions for one device from the same company Other US Medical Device Regulations 10
I Special 510k Imported Legacy Blogs 0

Similar threads

Top Bottom