SBS - The Best Value in QMS software

How to Select FDA Medical Device Product Code?

Mark Meer

Trusted Information Resource
#1
In the past, selecting an appropriate FDA product code for our devices wasn't a problem: either we selected based on predicates, or there was a code that neatly described our product.

Now, however, I'm a bit undecided. We have a device for which there are multiple potential product codes that might be applied:
(1) One has a good physical description (matches our device), but the listed indications are only a subset of the conditions for which our device intended
(2) One has a not-so good physical description (does not quite match our device), but the indications and intended use are spot-on
(3) One is very general in the description and the indications (very vague description, very general intended use, and no specific conditions specified)

My question is: is there any (mandated) reason why you wouldn't always choose the most general description possible? Assuming implications such as classification, regulation, review panel, etc. are all the same, why would you choose a more specific product codes (options (1) & (2)), and not always just choose the most general (option (3))?
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
I would go by the predicate. It makes things simpler and prevents added questions. The only cases I ran into where the device and the predicate didn't have the same procode were cases where the manufacturer actually intended the procode to be the same but the FDA decided that a different procode is more appropriate, during review.
 

Mark Meer

Trusted Information Resource
#3
I would go by the predicate. It makes things simpler and prevents added questions. The only cases I ran into where the device and the predicate didn't have the same procode were cases where the manufacturer actually intended the procode to be the same but the FDA decided that a different procode is more appropriate, during review.
Thanks Ronen, I agree. ...but if it's the case of a Class I (or otherwise 510(k) exempt), and/or there is no known predicate, what approach to take?
It seems to me like it makes the most sense to always select the most general available product code that aligns with the device (option 3 in the original post).
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Thanks Ronen, I agree. ...but if it's the case of a Class I (or otherwise 510(k) exempt), and/or there is no known predicate, what approach to take?
Even though it's not called "a predicate", for 510k-exempt devices you have to identify a sort-of "predicate" for the exemption to apply (see the regulations 8xx.9 sections). If you look up the exempt device's device listing you can find its procode.
Where there is no known predicate (or a device enabling the exemption) you will need to submit a De-Novo.
 

duinyk

Involved In Discussions
#5
Talking about product codes and predicate choices. Has the FDA already implemented the not older than 10 years predicates? Does anyone know if using a predicate of almost 17yrs could be an issue now with the FDA's current thinking?
 

Watchcat

Trusted Information Resource
#6
No, FDA hasn't implemented that proposal, which was to post a list of devices with predicates that were more than 10 years old. It didn't propose eliminating predicates that were older than 10 years.
 

Watchcat

Trusted Information Resource
#7
I will add that I did an analysis of the 55 comments FDA received on this proposal. I posted the results as a 7- or 8-part series in the RAPS Forum and on LinkedIn, I think, but not here, sorry, and no time now. At some point I plan to consolidate all 7 or 8 parts into a single document, which I will post here.

Bottom line, a diverse range of perspectives was represented, and pretty much everyone who commented on the proposal just said no to the whole thing. Quite a few commenters made extensive and compelling cases for older devices making better predicates than newer ones in many situations.

On regulations.gov, one is reminded that the comments are not votes. I don't know how often FDA posts something that is pretty much uniformly rejected, not just by everyone who comments, but by patients groups, trade associations, manufacturers, and individuals who represent a range of perspectives themselves. I'll be interested interested to see how FDA handles it when this happens.
 

Ronen E

Problem Solver
Staff member
Moderator
#8
I never really got the idea to begin with. If an "old" design is inadequate as a predicate (= representing a safe and effective solution), shouldn't it be removed from the market altogether?...
 

Watchcat

Trusted Information Resource
#9
The whole thing was seriously stupid, IMO. And I know I'm not lonely in that opinion.

I posted my own comments on regulations.gov. I posted it here too, don't know if you saw it. I didn't quite say it was seriously stupid, but anyone who isn't can read it between the lines.
 

duinyk

Involved In Discussions
#10
If you intend to bring a class II 510k exempt to the market, could you use or classify the device with two 510k exempt codes from two different regulation numbers? As in using two different predicate codes but for exempt devices.
 
Thread starter Similar threads Forum Replies Date
P Material selection - How do we select a raw material? Bolt made of SAE J994 grade 2 Customer and Company Specific Requirements 3
K How do you select the right grips for your tensile tests? Imported Legacy Blogs 0
Y Can manufacturer select AR for MDD different from AR for RED? EU Medical Device Regulations 5
B Historical Standard Deviation or Select Parts for MSA Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
S Excel Help - Equivalent of "Range($G$14:$AD$121).Select" in R1C1 notation Excel .xls Spreadsheet Templates and Tools 5
S A Standard for you to select Standards - ISO 16142-1 Other Medical Device Related Standards 1
R Is it possible to randomly select samples from 1 column to many column Using Minitab Software 2
B How important it is to select Parts that represent the Process Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
B How to select parts for a MSA Study Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 19
C UDI: HIBCC vs. GS1 - Recommendations regarding which one to select Other US Medical Device Regulations 2
T Select Updates for Non-Clinical Engineering Tests - Intravascular Stents Other US Medical Device Regulations 0
C When do I select Team for Black Belt Project? Six Sigma 3
R How to select appropriate standards for Multi-Functional Physical Therapy Equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
J How to select pieces for GR&R (Gage R&R) Studies? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
L How to select an Authorized Representative CE Marking (Conformité Européene) / CB Scheme 2
somashekar Definition Evaluate and Select ... What are the most common understandings of these words. Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 12
A Who to decide and select Internal Auditors and what are the criteria? Internal Auditing 18
R How to select the the target value from spec. limit (18 samples) Statistical Analysis Tools, Techniques and SPC 4
C How to select the requirements for Continuous Sampling Plan (CSP-1&F), Mil-Std 1235C? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
A How to select equipment for MSA (Measurement Systems Analysis) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 9
C ASQ Examination Fees Increasing for Select Certifications Professional Certifications and Degrees 1
H How to Select a Statistically Valid Sampling Plan Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
R Six Sigma vs. TQM - How to Select and What are their Differences? Six Sigma 2
M How to select a consultant to help out for ISO 14001 Certification? Consultants and Consulting 11
kedarg6500 How to Select Checking Aids APQP and PPAP 7
D Variable sample size - Xbar-s charts - How to select A3 and B4 Statistical Analysis Tools, Techniques and SPC 11
C What is the Best Way to Select a Registrar? The Reading Room 3
S Attribute MSA - Risk analysis -- How to select the samples Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
Q Gage R&R - How to select samples near the limits? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
S How to select the part for Gage R&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
Casana How to select a consultant? What criteria to consider and look for when looking Consultants and Consulting 5
P How To Select Regulatory (Regulatory Requirements?) For Implement Iso/ts 16949 IATF 16949 - Automotive Quality Systems Standard 3
Y How to select the most suitable person to be the Management Representative? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
B Operating Range & Measurement System Discrimination:How to select parts for R&R test? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
S Examples of FDA acceptable Software Design Specification (SDS) Medical Device and FDA Regulations and Standards News 6
F Labelling to comply with both FDA and MDR US Food and Drug Administration (FDA) 6
Watchcat FDA vs NB Fees? Other US Medical Device Regulations 7
K FDA Registration and listing weird situation Medical Device and FDA Regulations and Standards News 4
D FDA Guidance on Computer Software Assurance versus 21 CFR Part 11 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
D FDA Information - Revising the Instructions for Use US Food and Drug Administration (FDA) 0
S Transitional Adolescent A and B - "CDRH PREMARKET REVIEW SUBMISSION COVER SHEET FORM FDA 3514" Medical Device and FDA Regulations and Standards News 1
B FDA requirement for CAPA Signoff ISO 13485:2016 - Medical Device Quality Management Systems 6
P MSDS for MVQ FDA White, Vinyl Methyl Silicone Rubber EU Medical Device Regulations 4
S Manufacturing Process FDA FOIA Medical Device and FDA Regulations and Standards News 3
S Manufacturing Process FDA FOIA US Food and Drug Administration (FDA) 4
S Mechanical Test Under FDA Freedom of Information Act Medical Device and FDA Regulations and Standards News 5
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3

Similar threads

Top Bottom