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.
Many thanks!
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.
Many thanks!