How FDA define a new variant/generation or a new device

#1
We would like to make some change to a device, but don't know if it belong to a change or a new device.
Wonder if FDA consider product code as the key to judge if it is a new variant(generation) or a new device.
 
Elsmar Forum Sponsor
#3
Than you Zero_yield for reply. wonder if these guidances only apply to a change? or this decision tree is the way to differentiate variant and new device?
 

EmiliaBedelia

Involved In Discussions
#4
Than you Zero_yield for reply. wonder if these guidances only apply to a change? or this decision tree is the way to differentiate variant and new device?
FDA does not actually care what your part numbers are. You can keep the same part number forever. You can change the part number every time you modify the device. You can change the part number every year. You can forget part numbers entirely and only use GTINs. FDA primarily cares about the substance of the change and what aspects of the device are being modified.
The key consideration for part numbers (and any other product identifiers like lot numbers/serial numbers/etc) is more logistical: how are you controlling the devices throughout your manufacturing/shipping process, and are you accurately controlling changes to the devices? If you make a change to a device, how are you ensuring that the right regulatory actions are happening before you start selling it?

In practice, I've mostly seen part numbers change when there is, in fact, a dramatic change to a device that would require significant regulatory action and significant control of the parts internally. If you decide to change the material of an orthopedic implant, for example, this would definitely require a new 510k and regulatory submissions around the world. You could not sell this new device until you have received clearance. So, you'd probably want a new part number so as to differentiate between this new version and the old version.

So, ignore the part number right now. Read the guidance and determine whether you need to file a new 510k or not. Then you can determine whether logistically it makes sense to keep the same part number or not. Even if you do have to file a new 510k, you CAN choose to keep the same part number.... you just need to make sure that you are keeping track of which devices can go where. In a similar vein, you can choose to keep the same part number even if you don't need to do a submission, if that works better for your company.
 

Zero_yield

"You can observe a lot by just watching."
#5
Thanks, EmiliaBedelia. That's the way I was reading the guidance documents (i.e., the FDA only cares about the device and the processes used to create / test / package / label / sterilize / market / etc. the device), but I couldn't find an explicit reference about part numbers.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#6
I made a checklist we use that I posted on this forum a few years back. If you search for FDA 510(k) you should find it.
 
#7
FDA does not actually care what your part numbers are. You can keep the same part number forever. You can change the part number every time you modify the device. You can change the part number every year. You can forget part numbers entirely and only use GTINs. FDA primarily cares about the substance of the change and what aspects of the device are being modified.
The key consideration for part numbers (and any other product identifiers like lot numbers/serial numbers/etc) is more logistical: how are you controlling the devices throughout your manufacturing/shipping process, and are you accurately controlling changes to the devices? If you make a change to a device, how are you ensuring that the right regulatory actions are happening before you start selling it?

In practice, I've mostly seen part numbers change when there is, in fact, a dramatic change to a device that would require significant regulatory action and significant control of the parts internally. If you decide to change the material of an orthopedic implant, for example, this would definitely require a new 510k and regulatory submissions around the world. You could not sell this new device until you have received clearance. So, you'd probably want a new part number so as to differentiate between this new version and the old version.

So, ignore the part number right now. Read the guidance and determine whether you need to file a new 510k or not. Then you can determine whether logistically it makes sense to keep the same part number or not. Even if you do have to file a new 510k, you CAN choose to keep the same part number.... you just need to make sure that you are keeping track of which devices can go where. In a similar vein, you can choose to keep the same part number even if you don't need to do a submission, if that works better for your company.
Thanks EmiliaBedelia, by PRODUCT CODE I mean 3 alphabets FDA product code, i.e. classification product code and subsequent product code.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#9
Guidance Ref. No.
Question
Answer
Rationale
MAIN FLOWCHART
WHEN TO FILE A 510(K) AFTER CHANGE TO A LEGALLY MARKETED DEVICE

1
Change made with intent to significantly improve the safety or effectiveness of the device?
Yes -New 510K / No – See Question 2
No
Label updates Only
2
Labeling change?
Yes -See Chart A / No – See Question 3
Yes
See Below
3
Technology, engineering or performance change?
Yes -See Chart B / No – See Question 3
No
No Changes
4
Materials change?
Yes -See Chart C / No – Documentation
No
No Changes
FLOWCHART A – LABELING CHANGES?
A1
Does the change affect the indications for use statement?
Yes – See A1.1 / No – See Question A2
No
Not Changed
A2
Does the change add or delete a contraindication?
Yes -New 510K / No – See Question A3
No
Not Changed
A3
Is this a change in the warnings or precautions?
Yes – See A1.1 / No – See Question A4
No
Not Changed
A4
Could the change affect the directions for use?
Yes – See A1.1 / No – Documentation
No​
Not Changed
A1.1
Is it a change from a device labeled for single use only to a device labeled as reusable?
Yes – New 510K / No – See Question A1.2
No
Not Changed
A1.2
Is it a change from Rx to over the counter OTC use?
Yes – New 510K / No – See Question A1.3​
No
Not Changed
A1.3
Is it a change to the device name or to solely improve readability or clarity?
Yes – Documentation / No – See Question A1.4
No
Not Changed
A1.4
Does the change describe a new disease, condition, or pt pop that the device is intended in diagnosing, treating, preventing, curing or mitigating?
Yes – Documentation / No – See Question A1.5
No
Not Changed
A1.5
Does a risk-based assessment identify any new risks or significantly modified existing risks?
Yes – 510K see chart / No – Documentation
No

FLOWCHART B – TECHNOLOGY, ENGINEERING, PERFORMANCE CHANGES?
B1
Is the device an IVD?
Yes – See Chart D / No – See Question B2
N/A​

B2
Is it a control mechanism, operating principle, or energy type change?
Yes – New 510K / No – See Question B3
N/A

B3
Is it a change in sterilization, cleaning, or disinfection?
Yes – See Question B3.1 / No – See Question B4
N/A

B3.1
Is it a change to a Cat. B or novel method, does it lower the SAL, or is it a change to how the device is provided?
Yes – New 510k / No – See Question B3.2
N/A

B3.2
Could the change significantly affect performance/ biocompatibility?
Yes – New 510k / No – Documentation
N/A

B4
Is there a change in packaging or expiration dating?
Yes – See Question B4.1 / No – See Question B5
N/A

B4.1
Is the same method or protocol, described in previous 510(k), used to support change?
Yes – Documentation / No – new 510k
N/A

B5
Is it any other change in design (e.g., dimensions, performance specifications, wireless communications, components or accessories, patient/user interface)?
Yes – See Question B5.1 / No – Documentation
N/A​

B5.1
Does the change significantly affect the use of the device?
Yes – new 510k / No – See Question B5.2
N/A

B5.2
Does a risk assessment identify any new or significantly modified risks?
Yes – new 510k / No – See Question B5.3
N/A

B5.3
Is clinical data necessary?
Yes – new 510k / No – See Question B5.4
N/A

B5.4
Any unexpected issues from V&V activities?
Yes – new 510k / No – Documentation
N/A

FLOWCHART C – MATERIAL CHANGES?
C1
Is the device an IVD?
Yes – See Chart D / No – See Question C2
N/A

C2
Change in material type, formulation, chemical composition, or the material’s processing?
Yes – See Question C3 / No – Documentation
N/A

C3
Will the changed material directly or indirectly contact body tissues or fluids?
Yes – See Question C4 / No – See Question C5
N/A

C4
Does a risk assessment identify any new or increased biocompatibility concerns?
Yes – See Question C4.1 / No – See Question C5
N/A

C4.1
Has the manufacturer used the same material in a similar legally marketed device (including formulation, processing, type and duration of contact, etc.)?
Yes – See Question C5 / No – New 510k
N/A

C5
Could the change affect performance specifications?
Yes – See Question B5 / No – Documentation
N/A

SOFTWARE CHANGES?
1
Is the change made solely to strengthen cybersecurity and does not have any other impact on the software of the device?
Yes – Documentation / No – See Question 2
No
No changes to Software
2
Is the change made solely to return the system into specification of the most recently cleared device?
Yes – Documentation / No – See Question 3a
No
No changes to Software
3a
Does the change introduce a new risk or modify an existing risk that could result in significant harm and that is not effectively mitigated in the most recently cleared device?
Yes – new 510k / No – See Question 3b
No
No changes to Software
3b
Does the change create or necessitate a new risk control measure or a modification of an existing risk control measure for a hazardous situation that could result in significant harm?
Yes – new 510k / No – See Question 4
No
No changes to Software
4
Could the change significantly affect clinical functionality or performance specifications that are directly associated with the intended use of the device?
Yes – new 510k / No – Evaluate Section VI
No
No changes to Software
Section VI
Infrastructure - Does this introduce modifications made to the software support system?
(examples of insignificant/significant changes in guidance)
No
No changes to Software
Section VI
Architecture - Does this introduce modifications to the overall structure of the software?
(examples of insignificant/significant changes in guidance)
No
No changes to Software
Section VI
Core algorithm - Does this introduce modifications made to an algorithm that directly impact or contribute to the device’s intended use?
(examples of insignificant/significant changes in guidance)
No
No changes to Software
Section VI
Clarification of Requirements – No Change to Functionality - Does the change clarify software requirements after a product has received premarket clearance?
(examples of insignificant/significant changes in guidance)
No
No changes to Software
Section VI
Cosmetic Changes – No Change to Functionality – Is this a change to the appearance of the device that does not impact the clinical use of the device?
(examples of insignificant/significant changes in guidance)
No​
No changes to Software
Section VI
Reengineering and refactoring - Does this change:​
Examine and alter software to reconstitute it in a new form, and includes the subsequent implementation of the new form?
Restructure the software program’s internal structure without changing its clinical performance specification.
(examples of insignificant/significant changes in guidance)
No
No changes to Software
Section VI
Additional Software Changes not addressed in Guidance Section VI shall be documented below:
No
No changes to Software
END OF DEVICE SOFTWARE CHANGE DECISION MATRIX
 

EmiliaBedelia

Involved In Discussions
#10
Thanks EmiliaBedelia, by PRODUCT CODE I mean 3 alphabets FDA product code, i.e. classification product code and subsequent product code.
Oh! I am so sorry to misunderstand your initial question.

In that case... You should still use the "Deciding When to File a 510k" guidance to assess your change. The product code is not entirely relevant - the short answer is that no, the product code does not determine on its own whether you have a new device or not.
Again, FDA cares about the overall impact to the device itself- the product code is just a description to help categorize the product.
You can make a change to an existing device that would still fall into the same product code bucket that would still be treated as "new" (requiring a submission).

If you are making a change to the device that changes a product code, you are most likely changing the intended purpose, general operating principle, labeling, performance specifications, and/or design of the device... all things that would trigger a new submission for a class II device.

If you have a class I device that doesn't require pre-market notification, you should still assess your change to make sure that it still falls within an exempt product code. If the product code changes you probably do have a "new device", but that doesn't necessarily mean that it needs a submission.
 
Thread starter Similar threads Forum Replies Date
M Clinical evaluation process of FDA and MDR Medical Device and FDA Regulations and Standards News 2
S Is it possible to obtain FDA clearance (510k) without meeting QSR? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Biocompatibility testing ISO-10993 for FDA submission Other Medical Device Related Standards 7
Ed Panek FDA Submission Question US Medical Device Regulations 2
Y The day after the FDA US Food and Drug Administration (FDA) 2
U FDA foreign inspection and COVID19 US Medical Device Regulations 4
Y Convenience pack FDA US Food and Drug Administration (FDA) 3
B FDA regulations medical device prescription fulfillment DME question US Medical Device Regulations 0
N FDA medical devices US Food and Drug Administration (FDA) 1
R US FDA 510k Australia TGA US Food and Drug Administration (FDA) 0
G FDA Annual Registration and Listing US Food and Drug Administration (FDA) 7
T Book Excerpt: Drugs and the FDA: Safety, Efficacy, and the Public’s Trust Book, Video, Blog and Web Site Reviews and Recommendations 0
E The FDA regulations (21 CFR 312.3): Is it allowable that IND sponsor involves more than one individual or organization? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
P Looking for Korean FDA Drug Master File requirements for packaging systems. Other Medical Device and Orthopedic Related Topics 1
M IEC 62366 Hazard-related Use Scenario vs FDA Critical Task EU Medical Device Regulations 3
N Free sale and FDA US Food and Drug Administration (FDA) 1
N FDA class 1 US Food and Drug Administration (FDA) 6
G UDI in EU vs FDA EU Medical Device Regulations 1
S Initial Audit FDA US Medical Device Regulations 3
T FDA PMA review process - advisory panel timing? Other Medical Device and Orthopedic Related Topics 0
E FDA & Internal Audits US Medical Device Regulations 3
N Importing into US without 510K/FDA Clearance US Medical Device Regulations 1
N FDA class 2 Device QS Requirements US Food and Drug Administration (FDA) 2
T FDA labeling requirements US Food and Drug Administration (FDA) 2
S FDA Contract Manufacturer and Applicant US Food and Drug Administration (FDA) 0
R IVD Software FDA/CLIA doubts Medical Device and FDA Regulations and Standards News 1
R IVD software FDA and CLIA US Food and Drug Administration (FDA) 2
T FDA level of concern vs IEC 62304 safety classification - 510(k) exempt device Other US Medical Device Regulations 13
K Change in address on ERLM US FDA: Implications to import US Medical Device Regulations 0
V FDA 510K - Pre Submission Query US Food and Drug Administration (FDA) 6
M Document Control ISO and FDA ISO 13485:2016 - Medical Device Quality Management Systems 7
C FDA 510k documentation requirements US Food and Drug Administration (FDA) 1
T Link GMDN code and FDA product code US Medical Device Regulations 5
cgaro62 Does FDA apply to a non-medical 13485 certified custom manufacturing company? ISO 13485:2016 - Medical Device Quality Management Systems 11
M How does FDA determine OAI and VAI after inspection? ISO 13485:2016 - Medical Device Quality Management Systems 0
K Non-Device MDDS Clarifications (FDA) US Food and Drug Administration (FDA) 7
Ed Panek Consultant Request SaMD AI "Expert" FDA US Food and Drug Administration (FDA) 2
Sam Lazzara Record signature requirements in proposed FDA 21 CFR 820 QMS Regulation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
shimonv FDA-recognized Standards US Food and Drug Administration (FDA) 0
R FDA ECG Data Requirements Medical Information Technology, Medical Software and Health Informatics 3
L Language of quality system in case of FDA inspection US Food and Drug Administration (FDA) 1
M Can you import medical device not FDA approved into the USA under an IND application? US Food and Drug Administration (FDA) 2
Ed Panek FDA Submits to White House Plan to Harmonize with ISO 13485 US Medical Device Regulations 2
Melissa Contract Mfg--to Manufacturer with the FDA ISO 13485:2016 - Medical Device Quality Management Systems 4
Ed Panek ANNUAL FDA Registration - What 510(k) number to use? US Food and Drug Administration (FDA) 1
Y FDA vs (EU) 2021/2226 Electronic Instructions for Use (eIFUs) US Medical Device Regulations 1
M FDA Medical device reporting (Manufacturer in US; contract manufacturer OuS) US Food and Drug Administration (FDA) 0
JesseE Electronic signatures FDA CFR 820 ISO 13485:2016 - Medical Device Quality Management Systems 3
C FDA logo for marketing US Food and Drug Administration (FDA) 3
G FDA clearance for a device that can't be used clinically (at present) Other US Medical Device Regulations 5

Similar threads

Top Bottom