510(k) cleared, Rx only and home use

PearlKetchup

Starting to get Involved
#1
Hi all,

Thank you everyone for all of the posts over the years. I am excited to get involved here and appreciate the advice I've been able to find so far. I am new in my role as a QA/RA and at a medical device startup. I'm looking for help on how we can navigate the question below.

We have a 510(k) cleared, class II device (Rx only) that has been in use in supervised home care settings. The device has been very successful there and patients/providers like it. Patients are asking if they can keep the device with them at home and continue to use it once their supervised home health visits end. However, we do not allow that as our labeling/IFU says "not for home use". We are considering allowing patients to be able to keep it and use it unsupervised at home, and finding out what we'd need to do for this to be correctly done.

From my initial research it seemed we could allow the home use but then I learned about the contraindication. Would it still be possible for informed/trained patients to use the device on their own even with that on the labeling? It's my understanding that patients would remain under the care of their provider. Another option we are considering is to do a special 510(k) to clear new labeling and new IFU for lay people.
I don't know if self-care/self-operation was part of the design inputs, I need to check as I wasn't with the company at the time and am still getting up to speed.

Being new, I don't have a lot of regulatory experience. I'd greatly appreciate any insights Covers might be able to provide.


:agree: Many thanks!
 
Elsmar Forum Sponsor

Mark Meer

Trusted Information Resource
#2
I'm sure you're probably already aware of the FDA guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device
It lays out the decision flowchart quite well. Ultimately, you are responsible for making a risk assessment. Be sure to consider if it impacts the substantial equivalence assessment from your previous 510(k).

If you go the documentation route, you will have to be diligent in updating your risk and usability documentation.
Good luck!
 

yodon

Staff member
Super Moderator
#4
Just to throw a little more gas on the fire...

As @nvquality pointed out, you may need to substantially overhaul (or create) your usability engineering file.

And, if it's an electrical medical device, you're probably going to need to test against 60601-1-11.
 

PearlKetchup

Starting to get Involved
#5
Thanks for the guidance pointers @Mark Meer and @nvquality. Bouncing this around here has been very helpful to my sanity and understanding. At this point, I'm leaning towards the special 510(k) so we can get it on the label and open up that market to the device. I've spent a few hours going over the Home Use Initiative documents and site and while there's quite a bit to parse it seems doable given time and effort. The company is committed to this so I think we can pull it off.

@yodon, yes, there are electronics, great point. Off the top of my head I felt like it'd require at the very least a new risk assessment (as new harms are introduced in home care), usability study, and likely more EMC testing.
We did test to 60601 for the initial 510(k) submission, but I suppose you are confirming it'd have to be redone?

Thank you again, all!
 

yodon

Staff member
Super Moderator
#6
60601 is a suite of tests. -1 is the basic group. There are dozens of collateral standards, like the -1-11 which are only applied if your device meets the criteria. If you did the -1 tests and have not changed the device (other than your labeling indications) that shouldn't have to be re-done.
 

PearlKetchup

Starting to get Involved
#8
Hello all, I am back.

We're still thinking through the implications and unpacking all of the procedures and documents that will have to updated. Making slow but sure progress. It's right that the testing will need to be redone. In our case, likely -1 and -2 due to some changes in the electronics, and -11 for home use. The comment about usability was spot on. It is virtually non-existent for the device. It's my understanding that with the special 510(k) pathway the predicate it essentially the device itself. I don't believe that the changes we are proposing will affect substantial equivalence.

Another thought I had the other week was that in the current paradigm, we don't need to comply with HIPAA as only healthcare providers contact our company for technical service of the device. If we were to open up use of the device in the home healthcare space, we would potentially have patients call us and provide their PHI as part of complaint handling/resolution.

Do any of you have any tips on this additional requirement? I am again running up against the limits of my understanding and would greatly appreciate some pointers in the right direction.

Thanks <3
 

Ronen E

Problem Solver
Staff member
Moderator
#9
It's my understanding that with the special 510(k) pathway the predicate it essentially the device itself. I don't believe that the changes we are proposing will affect substantial equivalence.
Please note that moving from Rx only to home/lay use is a change in Intended Use, so "the device itself" (as cleared with the current Rx labeing) will likely not suffice as a sole predicate. You need to identify an equivalent device that's at least cleared as OTC / non-prescription.
 

PearlKetchup

Starting to get Involved
#10
at least cleared as OTC / non-prescription.
Hi Ronen, thanks for the reply. I don't mean to sound bullheaded and I appreciate your help. I am having a hard time with this point myself and I thank you for bringing it up.

My original post was not clear. The purpose is not to change availability from Rx to OTC. The device would continue to be Rx only. Patients or caregivers in home care settings would be trained by healthcare professionals prior operating the device on their own. Do you think SE to an OTC device need to be established in this care?

A complication to your suggestion is that I haven't yet found a cleared OTC product in my category. I've found some other cleared products that are similar in nature (materials, dimensions, power source) but as these devices don't have the same intended use I don't believe can be used as predicates. So I am not sure of the best course of action.

Thank you for your help.
 
Thread starter Similar threads Forum Replies Date
Y Expanding the indications for use for a 510(k) cleared device Medical Device and FDA Regulations and Standards News 4
T Submitting MR Compatibility Data for 510(k) Cleared Device Other Medical Device and Orthopedic Related Topics 2
K Reporting a Change of Contract Manufacturer for a 510(k) cleared device Other US Medical Device Regulations 5
B Submit a 510(k) with a Predicate cleared but not Listed US Food and Drug Administration (FDA) 9
K 510(k) expanding the indication for use for a cleared device Other US Medical Device Regulations 9
W How to withdraw a cleared (but never sold in the US) 510(k) Medical Device? Other US Medical Device Regulations 7
S Predicate Material 510(k) US Food and Drug Administration (FDA) 1
S Predicate Material 510(k) Medical Device and FDA Regulations and Standards News 3
J US Device Listing when not the 510(k) owner Medical Device and FDA Regulations and Standards News 2
supadrai Possible to Submit a 510(k) if you have never, do not and cannot produce the device for which you're submitting the application? US Food and Drug Administration (FDA) 4
S Special 510(k) for orthopedic implant 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Label change - 510(k) Medical Device and FDA Regulations and Standards News 5
G We want to add Covid-2 /19 to our air filter 510 K Medical Device and FDA Regulations and Standards News 0
A The refund of 510(k) user fee Medical Device and FDA Regulations and Standards News 0
A Which guidance do you use for guiding the requirements of IFU for 510(k) submission? Medical Device and FDA Regulations and Standards News 5
A 510(k) review timeline 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
L Impact on 510(k) to use an additional manufacture US Food and Drug Administration (FDA) 0
T 510(k) submission - Which name should I use in the submission? Other US Medical Device Regulations 3
Watchcat Advantages to pursuing a Special 510(k) instead of a Traditional 510(k) Other US Medical Device Regulations 5
A 510(k) registration and listing US Food and Drug Administration (FDA) 1
Aymaneh Traditional 510(k) Declaration of Conformity Other Medical Device Regulations World-Wide 3
M Should 510(k) Predicates be Actively Listed Devices? Other US Medical Device Regulations 12
A Several sections of traditional 510(K) have the same or similar requirement of content. US Food and Drug Administration (FDA) 4
A Some questions about voluntary consensus standards in traditional 510(k) submission US Food and Drug Administration (FDA) 6
A Some doubts about traditional 510(k) submission US Food and Drug Administration (FDA) 5
A Bench test report translation to English for 510(k) submission Other US Medical Device Regulations 2
S Special 510(K) - Labeling change from Rx to OTC Other US Medical Device Regulations 11
J 510(k) for a control kit for an external IVD test kit 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T First 510(k) submission - Class II software as medical device US Food and Drug Administration (FDA) 4
M CE Mark and 510(k) -Global registration requirements for every country Other Medical Device Regulations World-Wide 3
Z 510(k) usage - Company has 2 physically similar products Medical Device and FDA Regulations and Standards News 2
K 510(K) File eCopy Submission 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
Q Need clarification on requirements.... Class i, gmp & 510(k) exempt Medical Device and FDA Regulations and Standards News 12
D Redacted 510(k)s - Example wanted Document Control Systems, Procedures, Forms and Templates 17
K Changing the Address in 510(K) Approved Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K Completing Design Controls after 510(k) Clearance Other US Medical Device Regulations 11
P Predicate Device Information for 510(k) Submission Medical Device and FDA Regulations and Standards News 4
M 510(k) 10993 Biocompability Testing Other US Medical Device Regulations 15
D First 510(k) Submission - Don't Forget Tips US Food and Drug Administration (FDA) 5
K Mammography Machine Bench Testing - FDA 510(K) US Food and Drug Administration (FDA) 5
D Is Human Factors testing mandatory for a 510(k) submission? Human Factors and Ergonomics in Engineering 16
D Pre-Submission after 510(K) Submission? Other US Medical Device Regulations 4
M Informational US FDA Final Guidance – Special Premarket Notification [510(k)] Pathway Medical Device and FDA Regulations and Standards News 0
M CBE (Change Being Effected) 510(k) Submission Other US Medical Device Regulations 2
K 510(K) Submission (Traditional) for Medical Device US Food and Drug Administration (FDA) 17
F Replacement Bone Screws - Traditional 510(k) or Special 510(k)? Other US Medical Device Regulations 7
M Informational US FDA Final guidance – Metal Expandable Biliary Stents – Premarket Notification (510(k)) Submissions Medical Device and FDA Regulations and Standards News 0
Watchcat Informational FDA Proposal to "Modernize" the 510(k) - 2019 Other US Medical Device Regulations 1
B 510(k) clearance claim on medical device product packaging Other US Medical Device Regulations 6
shimonv Referring to previously submitted biocompatibility results in a new 510(k) submission Other US Medical Device Regulations 1

Similar threads

Top Bottom