Fluoride sustained-release device

Aliken

Registered
#1
Hello Everybody,
This is the first time I'm posting a question in the forum. Thank you in advance for your help.
Our company is developing fluoride sustained-release dental ring (elastomer) to prevent and control caries.
At the moment, we are trying to identify potential predicate device(s) for the 510(K) route. There were several reports in the literature in the past describing similar devices. Still, it seems these remained in experimental stage as we couldn't find similar products in 510k database (nor in De novo).

The FDA clears several product types for fluoride delivery. E.g., fluoride varnishes - used for the prevention and control of dental caries, although in the past FDA has cleared only relief of hypersensitivity (or similar intended use claims) for such products, and never, as far as we know, any anti-caries claim.

We are well aware of the principle that the intended use of the device has to be the same or very similar (though indications for use may sometimes differ) to its predicate device. Likewise, we keep in mind that the primary mode of action has to be non-chemical.
There are ionomer devices that release fluoride (product code glass (Product Code: EMA, 21 CFR 872.3275 Dental cement). Besides, there are Resin tooth bonding agent and some other products, which include fluoride. These products are not very similar in terms of their form and technical characteristics, materials and MoA.

Our device seems to be best fitting to 21 CFR 872.5410 Orthodontic appliance and accessories. Examples K900824 FLUOR-I-CHAINS(TM) AND FLUOR-I-TIES(TM). Obviously, due to fluoride's extended-release, we would need to provide satisfactory safety and efficacy data to the FDA. Potentially, we could also use one of the available fluoride-releasing products as a reference device. Our opinion is that our device is not a right candidate for De Novo route, at least not as an initial move.

Would you agree with our analysis? Are we going in the right direction?
Many thanks,
Daniel
 
Elsmar Forum Sponsor

Watchcat

Trusted Information Resource
#2
Sorry your first post here hasn't been productive so far. I thought I'd give it a few days to see if anyone else responded.

From my perspective as a consultant, you are asking for quite a bit of work for free. When I do these types of assessments for clients, they typically cost $2500-5000, based on the time required to research the regulation and product codes, locate and review relevant information on previously cleared 510(k) and granted De novos, and read through the device description and the IFU.

The kicker is that, at the end of all that, I might not even tell you what classification I think your device is. Instead, my analysis may simply identify the issues FDA is likely to raise if you try to claim SE to a particular predicate versus another potential predicate versus going De novo. If I have a sense of whether the issue is or is not likely to lead to NSE, I will tell you that.

I don't know anything about your background or experience, but I think the amount of time and effort invested in determining appropriate classification (or lack thereof) has increased since the De novo got thrown into the mix. If your most recent experience was some years back, I think things have changed. These days I seldom come across a device that so obviously fit into a specific classification and product code, I could confirm that in a snap. But that's probably a biased sample, since the clients I work with wouldn't have been asking me in the first place, if it were that obvious.

The best first move is sometimes as much of a business decision as a regulatory decision, but I can help inform that decision by laying out possible strategies, and their pros and cons. If things look fuzzy, I may well recommend a pre-sub, or possibly a 513(g), but probably not.

I would be interested to hear from other regulatory professionals as to whether this is how they would go about this project or not. Maybe I'm making too big a deal out of it. People do give free advice here. Sometimes the question is straightforward. Even if it isn't, sometimes someone just happens to have recent experience with the same product space, so they can provide a pretty good answer without investing much of their time. Sometimes someone with some free time will do it for the sheer fun of it. (We don't do this work because we hate it.) And sometimes someone will just decide to give it a shot without spending much or any time on it, in which case the downside is that you might get advice that is worth what you paid for it.

If you don't get any other responses, and at some point you decide to secure the services of a regulatory consultant, I would of course be happy to assist you.
 
Last edited:

Aliken

Registered
#3
Sorry your first post here hasn't been productive so far. I thought I'd give it a few days to see if anyone else responded.

From my perspective as a consultant, you are asking for quite a bit of work for free. When I do these types of assessments for clients, they typically cost $2500-5000, based on the time required to research the regulation and product codes, locate and review relevant information on previously cleared 510(k) and granted De novos, and read through the device description and the IFU.

The kicker is that, at the end of all that, I might not even tell you what classification I think your device is. Instead, my analysis may simply identify the issues FDA is likely to raise if you try to claim SE to a particular predicate versus another potential predicate versus going De novo. If I have a sense of whether the issue is or is not likely to lead to NSE, I will tell you that.

I don't know anything about your background or experience, but I think the amount of time and effort invested in determining appropriate classification (or lack thereof) has increased since the De novo got thrown into the mix. If your most recent experience was some years back, I think things have changed. These days I seldom come across a device that so obviously fit into a specific classification and product code, I could confirm that in a snap. But that's probably a biased sample, since the clients I work with wouldn't have been asking me in the first place, if it were that obvious.

The best first move is sometimes as much of a business decision as a regulatory decision, but I can help inform that decision by laying out possible strategies, and their pros and cons. If things look fuzzy, I may well recommend a pre-sub, or possibly a 513(g), but probably not.

I would be interested to hear from other regulatory professionals as to whether this is how they would go about this project or not. Maybe I'm making too big a deal out of it. People do give free advice here. Sometimes the question is straightforward. Even if it isn't, sometimes someone just happens to have recent experience with the same product space, so they can provide a pretty good answer without investing much of their time. Sometimes someone with some free time will do it for the sheer fun of it. (We don't do this work because we hate it.) And sometimes someone will just decide to give it a shot without spending much or any time on it, in which case the downside is that you might get advice that is worth what you paid for it.

If you don't get any other responses, and at some point you decide to secure the services of a regulatory consultant, I would of course be happy to assist you.
Thank you for your reply. I just wanted to share my thinking and conclusions (and some frustration) while working on this case (I'm a regulatory consultant as well). I really didn't expect somebody will do the work for free; I apologize if my post is understood it that way. Rather, as you mentioned, people sometimes have experience with similar devices and want to share their knowledge. I believe the info I provided in my post could be useful as well and I hope to update the forum on how things proceed. And thank you again Watchcat for your feedback; will contact you if any help would be required. Best
 

Watchcat

Trusted Information Resource
#4
Glad you came back around. I do think it is always worth posting such questions at the Cove. However, it is also true that there are those who see online forums as a source of free consulting, and now and then tempers have gotten frayed here over this issue. I think some posters are new to regulated industry and have no idea what they are asking. ("You mean you can't just look it up?" :giggle:) Since I didn't know your background, I allowed for that and other possibilities. Also as a newcomer, I really did not want your question to just be ignored, and so I wanted to take a shot at explaining diplomatically (not normally my strong suit, LOL) why you might be getting crickets.

Anyway, now I'm sure you know all this better than I can say it. Welcome to the Cove!
 
Thread starter Similar threads Forum Replies Date
D ISO 13485 Certification - Class II product - Fluoride-free toothpaste - Records ISO 13485:2016 - Medical Device Quality Management Systems 1
Sidney Vianna An ISO Paper: In search of "Sustained Success" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
R ISO/DIS 9004 Managing for the sustained success of an organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Sidney Vianna ISO 9004 Managing for the sustained success of an organization - Update May 2017 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 89
shimonv Single lot release for sterile packaging 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
B New Release of CQI-12 Coatings Process (Revision 3- Release date- 7/2020) Customer and Company Specific Requirements 2
S Can a Contract Manufacturer "release" product on behalf of client to the market? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
I Release checklist EO sterilization process Medical Device and FDA Regulations and Standards News 3
I Revision History Date - date of updates or date of release? ISO 13485:2016 - Medical Device Quality Management Systems 2
B Verification/release medical device modules Other ISO and International Standards and European Regulations 7
S Software Release Note - Class A stand alone software medical device IEC 62304 - Medical Device Software Life Cycle Processes 2
DuncanGibbons Why is 8.4 post-delivery activities before 8.6 release of products and services in AS9100D? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M Informational Team-NB published a press release regarding the survey run among its members to analyse the certificates being issued Medical Device and FDA Regulations and Standards News 0
K Release testing for Combination Drug-Medical Device Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
S C of C release with accompanying EASA Form 1 for EASA Part 145 EASA and JAA Aviation Standards and Requirements 0
M Informational Health Canada begins release of clinical data Medical Device and FDA Regulations and Standards News 0
M Informational EU – Draft Functional specifications for the European Database on Medical Devices (Eudamed) – First release (High(1)) to be audited Medical Device and FDA Regulations and Standards News 0
M Informational Team-NB published a press release regarding the capacities of notified bodies to meet the sector needs Medical Device and FDA Regulations and Standards News 0
M Medical Device News Team-NB publishes a press release regarding the designation process in the framework of the IVDR regulation – Regulation (EU) 2017/746 Medical Device and FDA Regulations and Standards News 0
Q Release of the first batch of a cleared product before process validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Manufacturing date does not match release date? Other US Medical Device Regulations 2
P What is expected in a Medical Device Commercial Release Procedure Design and Development of Products and Processes 3
R Medical Device License - CMDCAS certificate release - Health Canada Canada Medical Device Regulations 0
A Certificate of release/certificate of conformity/certificate of compliance Other Medical Device and Orthopedic Related Topics 3
P Is ISO 9001 Model tested for its effectiveness by ISO before its release? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Pre-release version of the upcoming AIAG FMEA Revision 5 FMEA and Control Plans 1
V Is 'Compliance' a pre-requisite or is it ok before Batch Release to Market? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
V Purchasing Controls - Prerequisites for Batch Release or even before Purchase Order 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Change in Lot Release Specifications - Definition of "Substantial Change" EU Medical Device Regulations 14
JoCam User Manual Release before CE Mark EU Medical Device Regulations 5
Marc Release of New or Revised Procedures Document Control Systems, Procedures, Forms and Templates 5
E ISO 22000 new release in 2016? Food Safety - ISO 22000, HACCP (21 CFR 120) 1
I How to sample in a real time release process? AQL - Acceptable Quality Level 4
M Release authorization before or after packaging per 21 CFR 820.80(d)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
H POA procedure and EASA Form 1 Release EASA and JAA Aviation Standards and Requirements 2
shimonv Using sterilization data obtained from batch release for CE submission EU Medical Device Regulations 11
M A Question on EASA's "Release and Acceptance of Components" EASA and JAA Aviation Standards and Requirements 2
E Is Design Transfer to Production be complete prior to Release of first production lot 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Engineering Release Process Owner Manufacturing and Related Processes 4
Mikey324 Questionable Audit Findings after Rules 4th Edition Release IATF 16949 - Automotive Quality Systems Standard 4
Colin ISO 9001:2015 Delayed Release? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
G Validating a Process Based on Lot Release Criteria Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
S Annex II List A - Notified Body Fees - Design dossier review and batch release EU Medical Device Regulations 2
L Release of Audit Results Report to 3rd Party ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
H Extra checks to do when reviewing the batch records for release of products Records and Data - Quality, Legal and Other Evidence 2
T Expected release date for ISO 50003? Sustainability, Green Initiatives and Ecology 3
Sam Lazzara Lot Release Testing versus Process Validation Studies Qualification and Validation (including 21 CFR Part 11) 9
P MDD position on Final Inspection/Release Employee Experience/Training EU Medical Device Regulations 1
E Procedure for Control of the Release of Laboratory Notebooks Other ISO and International Standards and European Regulations 3
P Records authorizing release of product at Contract Manufacturer ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2

Similar threads

Top Bottom