Two separate 510k submissions for one device from the same company

P

PASO_ADEIL

#1
Hello dear colleagues,

is it possible for a company to submit 2 different 510k for the same medical device under the same brand name?



If yes then how is the design traceability [FONT=&quot]guarantied [/FONT] ?

Thank you very much...
 
Last edited by a moderator:
Elsmar Forum Sponsor

Mark Meer

Trusted Information Resource
#2
is it possible for a company to submit 2 different 510k for the same medical device under the same brand name?
Curious why you're asking? Do you plan to try? Are two exactly the same?

If yes then how is the design traceability guarantied
Not completely sure what you mean by "design traceability", but generally speaking product design, and unit traceability should be integrated into your quality system. This is independent of FDA 510(k)s.

With respect to the FDA, if the devices are different, they would have different device identifiers, and different device listings. ..but you are saying they are the same? Again, are they exactly the same?
 

Ronen E

Problem Solver
Staff member
Moderator
#3
I'm also curious as to the circumstances inviting such action.

regarding "design traceability" I think what the OP meant was "how would the FDA know to which of the submissions/clearances a given physical device, on the market, belongs?"

Following the same line of thought, I think that the FDA's primary/unambiguous identifier for a device in the 510(k) system is its brand name. If I'm correct then it shouldn't be possible to clear two submissions with the exact same brand name, at least not by the same manufacturer. I think that if the same physical device has two different uses that are submitted separately under two different 510(k)s, the FDA would expect at least some small difference in their designations, eg Widget vs. Widget-X.
 
P

PASO_ADEIL

#4
Thank you both very much! By design traceability, I meen design change control. Because if a company has cleared the same device (exactly the same device) two times (2x 510k) how and in which DHF will the changes be classified?

Because if a company has two 510k for the exact same design she must also have 2 DHF...

Thank you
 
P

PASO_ADEIL

#5
Well this is a very tricky situation…
The company that I am working for has an organizational structure that at the moment doesn’t cover the “manufacturer – contract manufacturer” demands.
There is a development department and manufacturing facility in Europe that also owns the design (DHF) of this medical device. The existing 510k was issued initially only for this facility. Latter on the company acquired also a facility in the US and they decided (without consulting the RA department) to change the ownership of this 510k and register both facilities as manufacturer and contract manufacturer simultaneously. So, there seems to be two manufacturers/contract manufacturers under the same. How can that even be possible?
The management (again without consulting the RA department) thought that two 510k might be the solution in this case.
If you ask me this would be time and money lose plus it will create internal completion.
Plus there is also the design change control. Which changes are to which 510k classified and of course as the colleague RONEN E mentioned, how would the FDA know to which of the submissions/clearances a given physical device, on the market, belongs?
Are my thoughts correct or am I missing something?
 

JeantheBigone

Quite Involved in Discussions
#6
That DOES sound like a tricky situation.

I can't see the benefit in submitting two identical 510(k)s for the exact same device with the exact same indications for use from the same manufacturer. I would also think that the FDA reviewer might even question it when they receive it, since the same panel (if not the same lead reviewer) would have to review it.

It is entirely possible for different locations to have different functions and be registered, ie "ACME Medical Devices Corp USA" "ACME Medical Devices Ltd Europe."

Changing the registration and listing information is a relatively simple matter. I may not have all the details, but it seems to me that the more logical solution would be to have the 510(k)-holder be listed as the manufacturer, this is where the DHF would reside. The other facility would be a contract manufacturer for that device, and register and list using the existing 510(k).
 

Michael Malis

Quite Involved in Discussions
#7
Well this is a very tricky situation…
The company that I am working for has an organizational structure that at the moment doesn’t cover the “manufacturer – contract manufacturer” demands.....
The existing 510k was issued initially only for this facility....

Latter on the company acquired also a facility in the US and they decided (without consulting the RA department) to change the ownership of this 510k and register both facilities as manufacturer and contract manufacturer simultaneously. So, there seems to be two manufacturers/contract manufacturers under the same. How can that even be possible?

Are my thoughts correct or am I missing something?
Hi Paso,

First, 510(k) does not belong to facility - it is belong to the company.
Therefore, company has the right to produce this product in any facility as long as product is validated and facility and product is registered appropriately.

Second, what you need is to update your technical file (TF) to show both facilities for thew same product. Assuming that new facility and product is validated and documented correctly, you have to:
1. Update facility registration
2. Notify your registrar and add this product to CE Cert.

After that you will have the same product manufactured in 2 (or more) facilities, but the product label will reflect the appropriate (one) facility address. You will need this for product traceability.

Regards,
Michael
 
U

uhohraggy

#8
What Michael said!

If you submit a second 510(k) for the same device the FDA will likely throw it back at you (I've seen this happen...well not literally, but they came back and asked what in the heck we were doing). The TF is for the EU, so that's if your product is marketed there.
 
#9
What Michael said!

If you submit a second 510(k) for the same device the FDA will likely throw it back at you (I've seen this happen...well not literally, but they came back and asked what in the heck we were doing). The TF is for the EU, so that's if your product is marketed there.
I have a question about this exact situation. The management in my company wants to submit another 510(k) in month for the product that is currently in 510(k) review. The change will change the indications.

I'm trying to tell them why this makes no sense logically, but they need something more firm to grasp. I also believed that the FDA would simply send back a 510(k) submission for a product already undergoing 510(k) review. Are you aware of any specific FDA guidance or other official word on having only one 510(k) in review at a time?

To me it's obvious that if the indications of the original predicate change while in review then what you're claiming equivalence to is no longer a valid predicate, but getting this through to the clueless masses of middle management is nearly impossible and they're too impatient to wait for one to get cleared before submitting the next.

Thanks!!
 

QAengineer13

Quite Involved in Discussions
#10
Based on what you mentioned in your previous comment , it looks like FDA can use their Refuse to Accept Policy for 510(k) for the first submission based on the changes in the intended use in your second 510k.

""To find a device substantially equivalent under section 513(i) of the FD&C Act, FDA must find that it has the same intended use as the predicate device, and either (1) has the same technological characteristics as the predicate device, or (2) has different technological characteristics, as defined at section
513(i)(1)(B), and the submission contains information, including appropriate clinical or scientific data if necessary, that demonstrates the device is as safe and effective as the predicate and does not raise different questions of safety and effectiveness than the predicate.""

Source: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm315014.pdf




I have a question about this exact situation. The management in my company wants to submit another 510(k) in month for the product that is currently in 510(k) review. The change will change the indications.

I'm trying to tell them why this makes no sense logically, but they need something more firm to grasp. I also believed that the FDA would simply send back a 510(k) submission for a product already undergoing 510(k) review. Are you aware of any specific FDA guidance or other official word on having only one 510(k) in review at a time?

To me it's obvious that if the indications of the original predicate change while in review then what you're claiming equivalence to is no longer a valid predicate, but getting this through to the clueless masses of middle management is nearly impossible and they're too impatient to wait for one to get cleared before submitting the next.

Thanks!!
 
Thread starter Similar threads Forum Replies Date
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 4
H ISO 13485 - Separate Microbiology Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
M UDI Database and EUDAMED - Will there be two separate databases? EU Medical Device Regulations 3
I Question 1 - Nitpicking on Document Approval - can a document approval record be separate? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Organization merger. Should we keep two separate ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 6
CPhelan Internal audit - Combine similar nonconformities in one or keep separate? Internal Auditing 6
S "X-MR charts do not separate piece-to-piece repeatability of the process" Statistical Analysis Tools, Techniques and SPC 2
R How far apart can you schedule separate areas or departments in your internal audit? Internal Auditing 4
S Do we need separate stand alone procedure for Suspect Unapproved Parts? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
J Facilities - Placing our assembly group into a separate building ISO 13485:2016 - Medical Device Quality Management Systems 8
W Product Audit - It must be a separate and distinct activity (IATF 16949) IATF 16949 - Automotive Quality Systems Standard 4
C ISO 14001 vs Existing Quality System - How to keep them separate? ISO 14001:2015 Specific Discussions 3
T Should Testing be a separate operation in the Control Plan? FMEA and Control Plans 5
B ISO 9001:2015 8.4 External Providers - If work is transferred to a separate facility ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Is a separate ISO/TS16949 certificate required for an extension site? IATF 16949 - Automotive Quality Systems Standard 4
T Two Separate Businesses - Only Part of Company Certified ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
D Separate Classifications for Medical Device Accessories EU Medical Device Regulations 2
R One-Time parts separate from QMS? Quality Manager and Management Related Issues 9
D Is a separate spreadsheet required for the ASL (Approved Supplier List)? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
R Connection to a generic separate power supply IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
S Regulations for Selling Convenience Kit vs. Selling Separate Parts Other US Medical Device Regulations 2
cscalise Separate Forms or Procedure Attachments - What's more common? Document Control Systems, Procedures, Forms and Templates 2
C Do separate sites need separate documents? Document Control Systems, Procedures, Forms and Templates 7
A Newly Incorporated Business - Separate Scope and/or Separate Cert? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
L Should Internal Audit CAPAs be kept separate from "normal" CAPAs? ISO 13485:2016 - Medical Device Quality Management Systems 6
P Separate procedures? ISO 14k System combined with OHSAS 18001 Occupational Health & Safety Management Standards 3
J Device Registration and Listing - Separate for Device and corresponding Instruments? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C How to handle Outsourcing with Same Site - Separate Cert ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B Two Separate Legal Entities - Manufacturer Vs. Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 20
Q Separate Quality System? Product line of a parent company spins off 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
P How to separate Product Design Review, Verification, and Validation Activities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
C What can you do if Quality is treated as a separate function in an organization? Quality Manager and Management Related Issues 24
C Separate Certification - Can I combine documents for ISO14001, OHSAS18001 & AS4801? Miscellaneous Environmental Standards and EMS Related Discussions 3
S IEC 62366 - Embedded Software in separate Usability Engineering File? IEC 62366 - Medical Device Usability Engineering 1
K How do ISO 9001 Requirements apply to 2 sets of specifications to 2 separate vendors? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D Include as an attachment or make a separate document? Advise on Document Numbering Document Control Systems, Procedures, Forms and Templates 1
F Multiple Business Lines (Separate Corporations) in one Facility AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
B Separate Clinical Trials in the US and the EU - When one fails - question US Food and Drug Administration (FDA) 3
M Can I be a legal manufacturer without being a separate legal entity? CE Marking (Conformité Européene) / CB Scheme 6
B Hospital Operating Room Regulations - Separate Entrances for Clean and Dirty Supplies Hospitals, Clinics & other Health Care Providers 4
SteveK Separate Medical Device 12V Power Source - What inspection and testing is required? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Does ISO/IEC 17025:2005 require the Laboratory to have separate ISO 9001 Procedures ISO 17025 related Discussions 4
R HVAC Contaminant Test for Two Separate Areas Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 6
R CNC OTS Software Validation Separate from full IQ/OQ/PQ for 21CFR Part 820 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
S Accessing data from separate worksheets in Minitab Using Minitab Software 3
Q Corrective Action as a Separate Procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
K Separate Quality Manuals for Different Sites Quality Management System (QMS) Manuals 3
T 10 CFR 50 App B, NQA-1, NCA-3800 - Separate Manuals? Various Other Specifications, Standards, and related Requirements 4
kisxena Separate NCR for each Part Number required or necessary? Nonconformance and Corrective Action 4
M Should QA procedures be separate processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8

Similar threads

Top Bottom