OTC with Rx Predicate - 510(k) for a Class II medical device

robertjbeck

Involved In Discussions
#1
I am planning a 510(k) for a class II medical device. unfortunately all of the likely predicates are Rx devices, and this new device will be OTC. FDA has responded with a statement that risks associated with having the device available to the general public must be considered and mitigated. This makes sense but is too general.

I have looked at the Rx-To-OTC Switch program for drugs, deNovo applications, and will probably take the pre-submission route.

so my questions are:

1) does anyone have any experience with submitting a 510(k) for an OTC device, especially where the predicate is not OTC?
2) is the lack of an OTC predicate a deal-breaker, or can it be dealt with by providing adequate human factors data?
 
Elsmar Forum Sponsor

mihzago

Trusted Information Resource
#2
Having an OTC predicate is not a requirement, but I'll have to provide clinical and/or usability data showing that the users can use the device properly without professional oversight e.g. ability to select the right product (size, shape, type, etc), properly apply or use it, understand the data or results provided, and take appropriate action.

One example I have handy is K140186.
 

robertjbeck

Involved In Discussions
#3
Well, I finally did send in a 510(k) with an Rx predicate. human factors study, risk assessment, MAUDE database search, predicate comparison, etc. The 510(k) was soundly rejected on the basis that Rx and OTC are different intended uses, therefore the predicate is invalid, therefore the 510(k) route is not the correct route. The reviewer suggested deNovo. working on a response ...
 

Mark Meer

Trusted Information Resource
#6
Well, I finally did send in a 510(k) with an Rx predicate. human factors study, risk assessment, MAUDE database search, predicate comparison, etc. The 510(k) was soundly rejected on the basis that Rx and OTC are different intended uses, therefore the predicate is invalid, therefore the 510(k) route is not the correct route. The reviewer suggested deNovo. working on a response ...
This is unfortunate.

I wonder if it might help to just submit the 510(k) with the predicate's Rx, and once that goes through, then apply to ammend the intended use afterwards to OTC.

Otherwise, do keep us up to date on the deNovo route. There are many Rx devices that now - through technological and design innovations - can be safely sold OTC...so I suspect there are a lot of people with the same question.
 
#7
That is frustrating :mad:- and actually inconsistent with what FDA guidance suggests - even final guidance issued just the other week!

#1 FDA's 510(k) guidance (c2014) suggests that Rx-OTC is merely a difference in indications, not intended use:

- Page 24 -
1. New or Modified Indications for Use – Same Intended Use*
In rare instances, FDA may rely upon clinical data to determine that new or modified indications for use fall within the same intended use as a predicate device.*
Illustrative Examples:*
The new device is an IVD that is indicated for over-the-counter use, whereas the predicate device is indicated for prescription use in the home or prescription use in a clinical setting. The newly indicated test population might fall within the intended use of the predicate device. Clinical data (demonstrating that the user can collect the sample, generate an accurate result, and adequately interpret the result) might establish that the indication for use for the new device falls within the intended use of the predicate device.*

#2 FDA's 510(k) modifications guidance (c2017) suggests it Rx-OTC could significantly affect S or E but again says it's a change in indications, not intended use. It also says it perhaps changes the "scope" of intended users, but that is not the same as intended use.

- Page 17 -
A.1.2 Is it a change from prescription (Rx) to over the counter (OTC) use?*
FDA has found that the directions for use necessary for health care professionals to use a device safely and effectively can be significantly different from the directions for use necessary for lay users to use that same device safely and effectively. Therefore, changing a device labeled for prescription use only to a device that is labeled for OTC use typically could significantly affect the safety or effectiveness and would likely require submission of a new 510(k). Changing a device labeled for OTC use to prescription use, however, would likely not require submission of a new 510(k) because it is unlikely that the associated labeling changes could significantly affect the safety or effectiveness of the device.

- Page 44 -
2. Change: The manufacturer of an IVD updates their labeling by changing the device from prescription use only to over-the-counter use.*
Relevant questions:*
A1– Is it a change in the indications for use statement? Yes. The revised labeling is a change in the indications for use statement of the device. Proceed to A1.1 -A1.5.*
A1.2 – Is it a change from prescription to over the counter (OTC) use? Yes. The revised labeling expands the scope of intended users of the device to lay users, which could significantly affect the safety or effectiveness of the device.*
Decision: New 510(k).*
 
Thread starter Similar threads Forum Replies Date
M Can a prescription type material be used as a predicate for an OTC material? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
Q Legal Manufacturer OTC Drug Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
S Special 510(K) - Labeling change from Rx to OTC Other US Medical Device Regulations 11
S OTC and Prescription use in EU regulation EU Medical Device Regulations 3
G How is the labeling of units cleared for both Rx and OTC uses handled? US Food and Drug Administration (FDA) 4
R US FDA Mandatory Labelling contents for an OTC medical device US Food and Drug Administration (FDA) 0
D FDA Registration - MD, OTC or Dietary Supplement US Food and Drug Administration (FDA) 0
O 510(k) Exempt OTC - Can we sell this device on Amazon? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S Class II to OTC conversion of a medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
O OTC Pharmaceuticals Labeling Submissions to the FDA Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
R Contract Manufacturing - OTC (Over the Counter) vs Prescription Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
Q FDA Requirements for Contract Manufacturers and OTC products US Food and Drug Administration (FDA) 4
B Anyone Attending OTC next week in Houston? (Offshore Technology Confernce) Oil and Gas Industry Standards and Regulations 0
S FDA Approval of Multifunction Device - OTC functions AND Prescription together! Other Medical Device and Orthopedic Related Topics 4
H What is required to support changes to API Manufacturers in OTC Drugs? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
C Very Small OTC (Over The Counter) Pharmaceutical Company Requirements US Food and Drug Administration (FDA) 6
S Switching 510(k) product from Prescription to OTC US Food and Drug Administration (FDA) 2
B New 510k for change to Intended Use - Prescription to OTC 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S FDA and OTC (Over the Counter) Software Use Classification Medical Information Technology, Medical Software and Health Informatics 9
AnaMariaVR2 FDA hits China Plant - OTC DRUG Nationwide Recall US Food and Drug Administration (FDA) 2
E Guidance/Tips to go Rx to OTC for Class II Medical Device Other US Medical Device Regulations 6
P Over The Counter (OTC) vs. POM (Prescription Only Medicine) Other Medical Device Regulations World-Wide 11
H OTC (Over The Counter) Wipe Product Labeling Guidelines - Question Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 6
E Does anyone know what a Part Number for an OTC Monographed Drug is? US Food and Drug Administration (FDA) 3
S IFU for combined OTC Medical Device in light of IEC 60601-1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Q Prescription vs. OTC (Over the Counter) Medical Device in Canada Canada Medical Device Regulations 4
N OTC (Over The Counter) Product FDA Label Change Requirements US Food and Drug Administration (FDA) 2
Scott Catron 21 CFR 201.66 Format And Content Requirements For OTC Drug Facts Labeling Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
M Prescription Devices and OTC Devices Labeling differences US Food and Drug Administration (FDA) 7
O Cosmetics (otc) with Drugs - Expiration dates and three years stability / shelf life ISO 13485:2016 - Medical Device Quality Management Systems 1
A What is Classification of Class A Certificate? OTC health care and consumer products Various Other Specifications, Standards, and related Requirements 1
K Seeking: Source for IOS International Symbology for OTC products ISO 13485:2016 - Medical Device Quality Management Systems 2
Q OTC S/W in Medical Devices (managing obsolescence) ISO 13485:2016 - Medical Device Quality Management Systems 2
P Predicate Device Indications for Use US Food and Drug Administration (FDA) 1
S Discontinuation of the Predicate Medical Device Medical Device and FDA Regulations and Standards News 1
Watchcat Does "Similar Device" = "Predicate"? EU Medical Device Regulations 7
S 510k: What to include if your own device is the predicate US Food and Drug Administration (FDA) 5
P Predicate Device Information for 510(k) Submission Medical Device and FDA Regulations and Standards News 4
M Predicate device - Search for a Class IIa device US Food and Drug Administration (FDA) 2
shrutisancheti Predicate device accelerated aging - 1 year of shelf life is already over Other Medical Device Related Standards 1
B Submit a 510(k) with a Predicate cleared but not Listed US Food and Drug Administration (FDA) 9
K Substantial Equivalence Predicate Device Testing Other US Medical Device Regulations 1
M What if information in predicate 510k is obviously wrong? Other US Medical Device Regulations 5
E 'Special' 510k as a Predicate Medical Device? Other US Medical Device Regulations 3
T Predicate device recalled - Still a valid predicate device? Other US Medical Device Regulations 7
R Working on a 510(k) that is very similar to the predicate device Other US Medical Device Regulations 4
R Identification of Russian Predicate Devices as part of the Registration Process Other Medical Device Regulations World-Wide 1
L Predicate Device for 510(k) - Disposable vs Reusable 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Registering a Class II Medical Device with no Predicate Device - FDA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Can a Predicate device be a higher class? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8

Similar threads

Top Bottom