Regulatory Open Forum

Hello RAPS Community,

I need your advice. The device is classified as Class II SaMD (ADHD). Only physicians are allowed to prescribe the device under FDA's special control. It is now the organization's goal to expand its prescriber group to include licensed healthcare professionals (such as nurse practitioners, psychologists, etc.). According to my thought process, this should be a special 510(K), but a few members of the organization believe this would be a letter to file in accordance with FDA guidance (when to submit a 510(K). I would greatly appreciate any guidance you can provide here. Thanks,

------------------------------
Bhupinder Singh
QA/RA Manager (RAC)
San Jose CA
United States
------------------------------

Hello Bhupinder,

Your question is difficult because the US FDA does not clearly defined a difference between healthcare professionals, i.e. a physician versus a nurse/technician (nor do many other regulatory agencies).  The individuals you are wanting to include appear to still be qualified and licensed so on one perspective might think this is covered by a "prescription" device.  Though  if you look at 21 CFR 801 and the Act about prescription devices it does say on order of Physician, Dentist, Veterinarian, but also wording 'of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device.'  This may be interpreted as the user group you are wanting to add.  In my experience, generally there is a distinction made between different levels of healthcare professionals.  There is more regulatory risk to accept these additional users in the "prescription use" indication which can be documented internally.  This of course would need to be supported with internal documentation, testing, usability, etc. to confirm this user group.  This is probably what I would lean toward.  You could reach out to the Branch or previous reviewer via email/call and inquire - not sure you would get an answer but might give an indication to the way they would lean.  The less regulatory risk would be to potentially do a Special 510(k) expanding the users of device - without changing the intended use - but this could also be tricky because some would view changing the user group to change of indication for use - thus a new Traditional 510(k) submission.  Those are some thoughts, though not exactly black and white as usual with regulatory questions.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 14-Dec-2022 10:56
From: Bhupinder Singh
Subject: Letter to File vs Special 510(K)

Hello RAPS Community,

I need your advice. The device is classified as Class II SaMD (ADHD). Only physicians are allowed to prescribe the device under FDA's special control. It is now the organization's goal to expand its prescriber group to include licensed healthcare professionals (such as nurse practitioners, psychologists, etc.). According to my thought process, this should be a special 510(K), but a few members of the organization believe this would be a letter to file in accordance with FDA guidance (when to submit a 510(K). I would greatly appreciate any guidance you can provide here. Thanks,

------------------------------
Bhupinder Singh
QA/RA Manager (RAC)
San Jose CA
United States
------------------------------

Thank you so much Richard for the valuable feedback.

------------------------------
Bhupinder Singh
QA/RA Manager (RAC)
San Jose CA
United States
------------------------------

Original Message:
Sent: 15-Dec-2022 01:40
From: Richard Vincins
Subject: Letter to File vs Special 510(K)

Hello Bhupinder,

Your question is difficult because the US FDA does not clearly defined a difference between healthcare professionals, i.e. a physician versus a nurse/technician (nor do many other regulatory agencies).  The individuals you are wanting to include appear to still be qualified and licensed so on one perspective might think this is covered by a "prescription" device.  Though  if you look at 21 CFR 801 and the Act about prescription devices it does say on order of Physician, Dentist, Veterinarian, but also wording 'of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device.'  This may be interpreted as the user group you are wanting to add.  In my experience, generally there is a distinction made between different levels of healthcare professionals.  There is more regulatory risk to accept these additional users in the "prescription use" indication which can be documented internally.  This of course would need to be supported with internal documentation, testing, usability, etc. to confirm this user group.  This is probably what I would lean toward.  You could reach out to the Branch or previous reviewer via email/call and inquire - not sure you would get an answer but might give an indication to the way they would lean.  The less regulatory risk would be to potentially do a Special 510(k) expanding the users of device - without changing the intended use - but this could also be tricky because some would view changing the user group to change of indication for use - thus a new Traditional 510(k) submission.  Those are some thoughts, though not exactly black and white as usual with regulatory questions.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 14-Dec-2022 10:56
From: Bhupinder Singh
Subject: Letter to File vs Special 510(K)

Hello RAPS Community,

I need your advice. The device is classified as Class II SaMD (ADHD). Only physicians are allowed to prescribe the device under FDA's special control. It is now the organization's goal to expand its prescriber group to include licensed healthcare professionals (such as nurse practitioners, psychologists, etc.). According to my thought process, this should be a special 510(K), but a few members of the organization believe this would be a letter to file in accordance with FDA guidance (when to submit a 510(K). I would greatly appreciate any guidance you can provide here. Thanks,

------------------------------
Bhupinder Singh
QA/RA Manager (RAC)
San Jose CA
United States
------------------------------

Hi Bhupinder:
Great question and I think Richard has put the issues well.
If you want to go the letter to file route, I would get a "regulatory opinion/position" from a local regulatory lawyer to confirm the interpretation and do some usability to show there is no demonstrable addition risk from adding the new group of prescribers (e.g. 10 ficticous situations with a question like, "do you prescribe or not and why?"). There is a risk that an FDA inspector might not agree, but my experience is if you have documented a good/believable/viable case for your interpretation of the law, you rarely get into trouble!
If you want to play it safe, I think a new traditional citing this as a new indication. Maybe you could consolidate with other changes to make the effort more worthwhile.
As you can probably infer, I do not like the middle path of a special. It is a half-way house, but one you are almost certainly "a little bit wrong": either you could of done a letter to file or you need to add a new indication.
Personally, I relish a fight; so if I can get a lawyer's letter to support my interpretation and a simple usability looks good, I would most likely go the letter to file route! As always "the Devil may be in the detail" so do check how the change is affected and the labeling!
Last thought, these questions are never easy .... but they are how you win "your spurs" in an organization!
Good luck whatever you decide!
Neil

------------------------------
Neil Armstrong FRAPS
CEO MeddiQuest Limited
Peterborough
United Kingdom
------------------------------

Original Message:
Sent: 14-Dec-2022 10:56
From: Bhupinder Singh
Subject: Letter to File vs Special 510(K)

Hello RAPS Community,

I need your advice. The device is classified as Class II SaMD (ADHD). Only physicians are allowed to prescribe the device under FDA's special control. It is now the organization's goal to expand its prescriber group to include licensed healthcare professionals (such as nurse practitioners, psychologists, etc.). According to my thought process, this should be a special 510(K), but a few members of the organization believe this would be a letter to file in accordance with FDA guidance (when to submit a 510(K). I would greatly appreciate any guidance you can provide here. Thanks,

------------------------------
Bhupinder Singh
QA/RA Manager (RAC)
San Jose CA
United States
------------------------------

FDA does not regulate who can prescribe medical devices, individual states do. It's very common that one state may only allow an MD/DO, but another a nurse or psychologist, or even in some cases a chiropractor (as is the case for concussion assessment).
I don't know how the user requirements were specified in your original submission and labeling, and if you require any specialized training, but it's possible you could change the Rx statement from intended for use by physician to licensed healthcare professional under LTF. It also depends how risk averse you or your organization is.

------------------------------
Michael Zagorski RAC
Director of Regulatory Affairs
Pittsburgh PA
------------------------------

Original Message:
Sent: 14-Dec-2022 10:56
From: Bhupinder Singh
Subject: Letter to File vs Special 510(K)

Hello RAPS Community,

I need your advice. The device is classified as Class II SaMD (ADHD). Only physicians are allowed to prescribe the device under FDA's special control. It is now the organization's goal to expand its prescriber group to include licensed healthcare professionals (such as nurse practitioners, psychologists, etc.). According to my thought process, this should be a special 510(K), but a few members of the organization believe this would be a letter to file in accordance with FDA guidance (when to submit a 510(K). I would greatly appreciate any guidance you can provide here. Thanks,

------------------------------
Bhupinder Singh
QA/RA Manager (RAC)
San Jose CA
United States
------------------------------

This message was posted by a user wishing to remain anonymous

Dear Bhupinder,

The decision to file or not depends on the wording in you the Indications For Use for which the device was cleared and/or whether the restriction to Rx only by a
 Physician was discussed in your submission or requested by FDA. 

If the risks associated with the use of the device required the restriction in the Indication and/or labeling is only to "physician" then a 510(k) is needed.  If it is indicated to be used on the order of a Licensed health care professionals, then  a letter to file should suffice. 

 

Original Message:
Sent: 14-Dec-2022 10:56
From: Bhupinder Singh
Subject: Letter to File vs Special 510(K)

Hello RAPS Community,

I need your advice. The device is classified as Class II SaMD (ADHD). Only physicians are allowed to prescribe the device under FDA's special control. It is now the organization's goal to expand its prescriber group to include licensed healthcare professionals (such as nurse practitioners, psychologists, etc.). According to my thought process, this should be a special 510(K), but a few members of the organization believe this would be a letter to file in accordance with FDA guidance (when to submit a 510(K). I would greatly appreciate any guidance you can provide here. Thanks,

------------------------------
Bhupinder Singh
QA/RA Manager (RAC)
San Jose CA
United States
------------------------------