Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Greetings everyone,

I have a regulatory conundrum that is really throwing me for a loop...

My company manufactures a nuclear uptake probe (Class I, exempt), which is intended for detecting the presence of radiopharmaceutical in an organ or body region during the uptake period as part of nuclear medicine procedures. The device is indicated for use as a tool to help assess whether a radiopharmaceutical injection remains near the injection site rather than circulating in the vascular system. Two sensors collect the photons given off by the radiation, a reader collects the data, and the data us uploaded to a website. The website application provides a time activity curve and provides information to the clinician regarding whether or not the injection was ideal (e.g. the clinician must decide with all of the evidence if the patient was infiltrated). We do not claim a percentage of radiopharmaceutical remaining at the injection site nor do we claim precision or accuracy measurements.

One of our customers at a clinical site would like to embark on a project with us. The customer would like to identify and track patients who have been significantly irradiated by infiltrations; goal would be to follow patients long-term for presentation of adverse tissue reactions. This would become part of the customer's patient follow-up process. 

To identify the patients that would be followed, the customer would like my company to provide dosimetry measurements using the time activity curve data they collected using our device. Dosimetry is the measurement, calculation and assessment of ionizing radiation dose absorbed by an object, in this case, the object would be the person. This dosimetry measurement would be utilized as ground truth and would be the basis for following the patient. 

Our labeling makes no current claims of being able to perform dosimetry calculations; we have not yet published anything on the subject (forthcoming). My company intends to teach the customer our methodology and base their decisions off of it.

Since following patients is already a process the customer performs, it's not a clinical study. However, my concern is with my company providing the dosimetry calculations. Are we overstepping our regulatory boundaries? The decision being made based on the calculation is only to follow a patient - it's not for patient disease management decisions.

Any help would be most appreciated.

I'd like to look at this question. Could you provide some additional information?

You say the device is Class I, exempt. Exempt from what?

What is the three letter Product Code for the device?

You say, "To identify the patients that would be followed, the customer would like my company to provide dosimetry measurements using the time activity curve data they collected using our device".

I infer that you don't have the patient data from your device. The customer would send it to you for the dosimetry analysis and you would return the result. You would provide this as a service to the customer.

However, you say that you will teach the dosimetry analysis method to the customer; you would not perform the analysis using their data.

Does your device (either the sensors or the reader) have software in it?

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 11-Aug-2020 10:20
From: Anonymous Member
Subject: Overstepping regulatory boundaries?!

This message was posted by a user wishing to remain anonymous

Greetings everyone,

I have a regulatory conundrum that is really throwing me for a loop...

My company manufactures a nuclear uptake probe (Class I, exempt), which is intended for detecting the presence of radiopharmaceutical in an organ or body region during the uptake period as part of nuclear medicine procedures. The device is indicated for use as a tool to help assess whether a radiopharmaceutical injection remains near the injection site rather than circulating in the vascular system. Two sensors collect the photons given off by the radiation, a reader collects the data, and the data us uploaded to a website. The website application provides a time activity curve and provides information to the clinician regarding whether or not the injection was ideal (e.g. the clinician must decide with all of the evidence if the patient was infiltrated). We do not claim a percentage of radiopharmaceutical remaining at the injection site nor do we claim precision or accuracy measurements.

One of our customers at a clinical site would like to embark on a project with us. The customer would like to identify and track patients who have been significantly irradiated by infiltrations; goal would be to follow patients long-term for presentation of adverse tissue reactions. This would become part of the customer's patient follow-up process.

To identify the patients that would be followed, the customer would like my company to provide dosimetry measurements using the time activity curve data they collected using our device. Dosimetry is the measurement, calculation and assessment of ionizing radiation dose absorbed by an object, in this case, the object would be the person. This dosimetry measurement would be utilized as ground truth and would be the basis for following the patient.

Our labeling makes no current claims of being able to perform dosimetry calculations; we have not yet published anything on the subject (forthcoming). My company intends to teach the customer our methodology and base their decisions off of it.

Since following patients is already a process the customer performs, it's not a clinical study. However, my concern is with my company providing the dosimetry calculations. Are we overstepping our regulatory boundaries? The decision being made based on the calculation is only to follow a patient - it's not for patient disease management decisions.

Any help would be most appreciated.

This message was posted by a user wishing to remain anonymous

Dan,

The product code for the device is IZD, regulation number 892.1320, device is a nuclear uptake probe.

The reader and the sensors have firmware. The reader data is uploaded using a downloader application and the data is viewable on a website.

The patient imaging data is not collected by my company. The dosimetry would need to be completed using the patient PET/CT images, time activity curve data (we collect this), and we would utilize our methods for calculation.
Original Message:
Sent: 12-Aug-2020 09:35
From: Dan O'Leary
Subject: Overstepping regulatory boundaries?!

I'd like to look at this question. Could you provide some additional information?

You say the device is Class I, exempt. Exempt from what?

What is the three letter Product Code for the device?

You say, "To identify the patients that would be followed, the customer would like my company to provide dosimetry measurements using the time activity curve data they collected using our device".

I infer that you don't have the patient data from your device. The customer would send it to you for the dosimetry analysis and you would return the result. You would provide this as a service to the customer.

However, you say that you will teach the dosimetry analysis method to the customer; you would not perform the analysis using their data.

Does your device (either the sensors or the reader) have software in it?

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States

Original Message:
Sent: 11-Aug-2020 10:20
From: Anonymous Member
Subject: Overstepping regulatory boundaries?!

This message was posted by a user wishing to remain anonymous

Greetings everyone,

I have a regulatory conundrum that is really throwing me for a loop...

My company manufactures a nuclear uptake probe (Class I, exempt), which is intended for detecting the presence of radiopharmaceutical in an organ or body region during the uptake period as part of nuclear medicine procedures. The device is indicated for use as a tool to help assess whether a radiopharmaceutical injection remains near the injection site rather than circulating in the vascular system. Two sensors collect the photons given off by the radiation, a reader collects the data, and the data us uploaded to a website. The website application provides a time activity curve and provides information to the clinician regarding whether or not the injection was ideal (e.g. the clinician must decide with all of the evidence if the patient was infiltrated). We do not claim a percentage of radiopharmaceutical remaining at the injection site nor do we claim precision or accuracy measurements.

One of our customers at a clinical site would like to embark on a project with us. The customer would like to identify and track patients who have been significantly irradiated by infiltrations; goal would be to follow patients long-term for presentation of adverse tissue reactions. This would become part of the customer's patient follow-up process.

To identify the patients that would be followed, the customer would like my company to provide dosimetry measurements using the time activity curve data they collected using our device. Dosimetry is the measurement, calculation and assessment of ionizing radiation dose absorbed by an object, in this case, the object would be the person. This dosimetry measurement would be utilized as ground truth and would be the basis for following the patient.

Our labeling makes no current claims of being able to perform dosimetry calculations; we have not yet published anything on the subject (forthcoming). My company intends to teach the customer our methodology and base their decisions off of it.

Since following patients is already a process the customer performs, it's not a clinical study. However, my concern is with my company providing the dosimetry calculations. Are we overstepping our regulatory boundaries? The decision being made based on the calculation is only to follow a patient - it's not for patient disease management decisions.

Any help would be most appreciated.

This message was posted by a user wishing to remain anonymous

Class I Exempt devices are exempt from GMPs except for complaint files (820.198) and records (820.180).

"The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files."
Original Message:
Sent: 12-Aug-2020 09:35
From: Dan O'Leary
Subject: Overstepping regulatory boundaries?!

I'd like to look at this question. Could you provide some additional information?

You say the device is Class I, exempt. Exempt from what?

What is the three letter Product Code for the device?

You say, "To identify the patients that would be followed, the customer would like my company to provide dosimetry measurements using the time activity curve data they collected using our device".

I infer that you don't have the patient data from your device. The customer would send it to you for the dosimetry analysis and you would return the result. You would provide this as a service to the customer.

However, you say that you will teach the dosimetry analysis method to the customer; you would not perform the analysis using their data.

Does your device (either the sensors or the reader) have software in it?

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States

Original Message:
Sent: 11-Aug-2020 10:20
From: Anonymous Member
Subject: Overstepping regulatory boundaries?!

This message was posted by a user wishing to remain anonymous

Greetings everyone,

I have a regulatory conundrum that is really throwing me for a loop...

My company manufactures a nuclear uptake probe (Class I, exempt), which is intended for detecting the presence of radiopharmaceutical in an organ or body region during the uptake period as part of nuclear medicine procedures. The device is indicated for use as a tool to help assess whether a radiopharmaceutical injection remains near the injection site rather than circulating in the vascular system. Two sensors collect the photons given off by the radiation, a reader collects the data, and the data us uploaded to a website. The website application provides a time activity curve and provides information to the clinician regarding whether or not the injection was ideal (e.g. the clinician must decide with all of the evidence if the patient was infiltrated). We do not claim a percentage of radiopharmaceutical remaining at the injection site nor do we claim precision or accuracy measurements.

One of our customers at a clinical site would like to embark on a project with us. The customer would like to identify and track patients who have been significantly irradiated by infiltrations; goal would be to follow patients long-term for presentation of adverse tissue reactions. This would become part of the customer's patient follow-up process.

To identify the patients that would be followed, the customer would like my company to provide dosimetry measurements using the time activity curve data they collected using our device. Dosimetry is the measurement, calculation and assessment of ionizing radiation dose absorbed by an object, in this case, the object would be the person. This dosimetry measurement would be utilized as ground truth and would be the basis for following the patient.

Our labeling makes no current claims of being able to perform dosimetry calculations; we have not yet published anything on the subject (forthcoming). My company intends to teach the customer our methodology and base their decisions off of it.

Since following patients is already a process the customer performs, it's not a clinical study. However, my concern is with my company providing the dosimetry calculations. Are we overstepping our regulatory boundaries? The decision being made based on the calculation is only to follow a patient - it's not for patient disease management decisions.

Any help would be most appreciated.

Hello,

What an interesting conundrum.  I'd like to see your reply to Dan as it seems you may be supporting a new indication (providing the dosimetry calculations).  Are these standard calculations which align to standard of care/clinical guidelines?  If not, you may be creating a new index and that would require regulatory review.

------------------------------
Gretchen Upton CQA, CCRP, RAC
RA/QA
Helotes TX
United States
------------------------------

Original Message:
Sent: 11-Aug-2020 10:20
From: Anonymous Member
Subject: Overstepping regulatory boundaries?!

This message was posted by a user wishing to remain anonymous

Greetings everyone,

I have a regulatory conundrum that is really throwing me for a loop...

My company manufactures a nuclear uptake probe (Class I, exempt), which is intended for detecting the presence of radiopharmaceutical in an organ or body region during the uptake period as part of nuclear medicine procedures. The device is indicated for use as a tool to help assess whether a radiopharmaceutical injection remains near the injection site rather than circulating in the vascular system. Two sensors collect the photons given off by the radiation, a reader collects the data, and the data us uploaded to a website. The website application provides a time activity curve and provides information to the clinician regarding whether or not the injection was ideal (e.g. the clinician must decide with all of the evidence if the patient was infiltrated). We do not claim a percentage of radiopharmaceutical remaining at the injection site nor do we claim precision or accuracy measurements.

One of our customers at a clinical site would like to embark on a project with us. The customer would like to identify and track patients who have been significantly irradiated by infiltrations; goal would be to follow patients long-term for presentation of adverse tissue reactions. This would become part of the customer's patient follow-up process.

To identify the patients that would be followed, the customer would like my company to provide dosimetry measurements using the time activity curve data they collected using our device. Dosimetry is the measurement, calculation and assessment of ionizing radiation dose absorbed by an object, in this case, the object would be the person. This dosimetry measurement would be utilized as ground truth and would be the basis for following the patient.

Our labeling makes no current claims of being able to perform dosimetry calculations; we have not yet published anything on the subject (forthcoming). My company intends to teach the customer our methodology and base their decisions off of it.

Since following patients is already a process the customer performs, it's not a clinical study. However, my concern is with my company providing the dosimetry calculations. Are we overstepping our regulatory boundaries? The decision being made based on the calculation is only to follow a patient - it's not for patient disease management decisions.

Any help would be most appreciated.

In the U.S., nuclear uptake probes are Class I 510(k)-exempt devices classified per 21 CFR 892.1320 in FDA Product Code IZD.

Remember that, pursuant to the principles of 21 CFR §812.2(c), sponsors and investigators are permitted the liberty to investigate legally marketed preamendment or substantially equivalent devices within the boundaries of the existing FDA-cleared indications without incurring the investigational regulatory obligations of Part 812 (except for 812.119).

Given that nuclear update probes are subject only to general controls [thus residing in an even lower risk-class than those subject to special controls (e.g., premarket notification and substantial equivalence)], then a nuclear uptake probe investigation should qualify pursuant to 812.2(c) as an "exempted investigation" when performed within the boundaries of the indications authorized by 21 CFR 892.1320 and FDA Product Code IZD.

Hope this helps.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
ComplianceAcuity, Inc.
Golden, CO
United States
www.complianceacuity.com
Note that I'm now far older and even uglier than in the photo above. Brace yourselves for my updated photo coming soon.
© Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 11-Aug-2020 10:20
From: Anonymous Member
Subject: Overstepping regulatory boundaries?!

This message was posted by a user wishing to remain anonymous

Greetings everyone,

I have a regulatory conundrum that is really throwing me for a loop...

My company manufactures a nuclear uptake probe (Class I, exempt), which is intended for detecting the presence of radiopharmaceutical in an organ or body region during the uptake period as part of nuclear medicine procedures. The device is indicated for use as a tool to help assess whether a radiopharmaceutical injection remains near the injection site rather than circulating in the vascular system. Two sensors collect the photons given off by the radiation, a reader collects the data, and the data us uploaded to a website. The website application provides a time activity curve and provides information to the clinician regarding whether or not the injection was ideal (e.g. the clinician must decide with all of the evidence if the patient was infiltrated). We do not claim a percentage of radiopharmaceutical remaining at the injection site nor do we claim precision or accuracy measurements.

One of our customers at a clinical site would like to embark on a project with us. The customer would like to identify and track patients who have been significantly irradiated by infiltrations; goal would be to follow patients long-term for presentation of adverse tissue reactions. This would become part of the customer's patient follow-up process.

To identify the patients that would be followed, the customer would like my company to provide dosimetry measurements using the time activity curve data they collected using our device. Dosimetry is the measurement, calculation and assessment of ionizing radiation dose absorbed by an object, in this case, the object would be the person. This dosimetry measurement would be utilized as ground truth and would be the basis for following the patient.

Our labeling makes no current claims of being able to perform dosimetry calculations; we have not yet published anything on the subject (forthcoming). My company intends to teach the customer our methodology and base their decisions off of it.

Since following patients is already a process the customer performs, it's not a clinical study. However, my concern is with my company providing the dosimetry calculations. Are we overstepping our regulatory boundaries? The decision being made based on the calculation is only to follow a patient - it's not for patient disease management decisions.

Any help would be most appreciated.

I see a few issues here in the question about whether you are overstepping your regulatory boundaries. I think a viable approach is to identify each proposed course of action, define the regulatory boundaries, and see if the action is inside or outside the boundaries. For most actions I've included a quotation from your initial post to clarify why I think that is an action.

Action: Modify the device to provide a dosimetry calculation.
This is a straw-man, since I don't believe a device modification is necessary. You would use the existing information provided by the device.

The regulatory boundary is the current Class I designation and the indications for use. Since there are no device modifications or indications for use changes planned, there are no regulatory boundary issues.

(I'm concerned that you don't provide precision and accuracy information, since this is a measuring device and, I infer, subject to calibration (or at least verification). However, I don't think this is relevant to the question at hand.)

Action: Publish a paper that explains how to use the time-activity curve to perform dosimetry calculations. "we have not yet published anything on the subject (forthcoming)"

I don't see any regulatory boundaries here. I don't think you are changing the intended use of the device. FDA would not object to a scientific paper.

Action: Teach the customer how to use the time-activity curve to perform dosimetry calculations. "My company intends to teach the customer our methodology and base their decisions off of it"

In this case, the customer performs the calculations and makes the decision on which patients to follow.

I don't see any regulatory boundaries here. I don't think you are changing the intended uses of the device. By analogy, you are giving the customer an advanced copy of the paper. If they were to wait for paper, they could do it themselves.

Action: Use customer supplied time-activity curves to perform dosimetry calculations and provide the results to the customer on a patient-by-patient basis. "the customer would like my company to provide dosimetry measurements using the time activity curve data they collected using our device"

I see a regulatory boundary with HIPPA. Presumably to don't currently have patient identity information, so there is nothing to protect. Make sure the customer codes the data so you cannot identify the patient.

I see a potential regulatory boundary with FDA. If you develop a software package to provide the results on a regular basis, instead of a few ad hoc calculations, that software is, I believe, a device even if you only provide the results and don't sell the software package.

My recommendation is to teach the customer how to do the calculation. Then they can interpret it to decide which patients to follow. All this would fall under the practice of medicine.

However, your company management could decide this is a good service to provide customers. If so, I believe, the analysis software would be a device and regulated by FDA.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 11-Aug-2020 10:20
From: Anonymous Member
Subject: Overstepping regulatory boundaries?!

This message was posted by a user wishing to remain anonymous

Greetings everyone,

I have a regulatory conundrum that is really throwing me for a loop...

My company manufactures a nuclear uptake probe (Class I, exempt), which is intended for detecting the presence of radiopharmaceutical in an organ or body region during the uptake period as part of nuclear medicine procedures. The device is indicated for use as a tool to help assess whether a radiopharmaceutical injection remains near the injection site rather than circulating in the vascular system. Two sensors collect the photons given off by the radiation, a reader collects the data, and the data us uploaded to a website. The website application provides a time activity curve and provides information to the clinician regarding whether or not the injection was ideal (e.g. the clinician must decide with all of the evidence if the patient was infiltrated). We do not claim a percentage of radiopharmaceutical remaining at the injection site nor do we claim precision or accuracy measurements.

One of our customers at a clinical site would like to embark on a project with us. The customer would like to identify and track patients who have been significantly irradiated by infiltrations; goal would be to follow patients long-term for presentation of adverse tissue reactions. This would become part of the customer's patient follow-up process.

To identify the patients that would be followed, the customer would like my company to provide dosimetry measurements using the time activity curve data they collected using our device. Dosimetry is the measurement, calculation and assessment of ionizing radiation dose absorbed by an object, in this case, the object would be the person. This dosimetry measurement would be utilized as ground truth and would be the basis for following the patient.

Our labeling makes no current claims of being able to perform dosimetry calculations; we have not yet published anything on the subject (forthcoming). My company intends to teach the customer our methodology and base their decisions off of it.

Since following patients is already a process the customer performs, it's not a clinical study. However, my concern is with my company providing the dosimetry calculations. Are we overstepping our regulatory boundaries? The decision being made based on the calculation is only to follow a patient - it's not for patient disease management decisions.

Any help would be most appreciated.

This message was posted by a user wishing to remain anonymous

"Dosimetry is the measurement, calculation and assessment of ionizing radiation dose absorbed by an object, in this case, the object would be the person. This dosimetry measurement would be utilized as ground truth and would be the basis for following the patient."

I don't see why not? In fact, this data should be relevant from the safety stand point! This should have been part of the approval process for the class 1 ( I am not a device regulatory person but from a therapeutic approval process, I think this is key information to have from Patient's safety perspective)
Original Message:
Sent: 11-Aug-2020 10:20
From: Anonymous Member
Subject: Overstepping regulatory boundaries?!

This message was posted by a user wishing to remain anonymous

Greetings everyone,

I have a regulatory conundrum that is really throwing me for a loop...

My company manufactures a nuclear uptake probe (Class I, exempt), which is intended for detecting the presence of radiopharmaceutical in an organ or body region during the uptake period as part of nuclear medicine procedures. The device is indicated for use as a tool to help assess whether a radiopharmaceutical injection remains near the injection site rather than circulating in the vascular system. Two sensors collect the photons given off by the radiation, a reader collects the data, and the data us uploaded to a website. The website application provides a time activity curve and provides information to the clinician regarding whether or not the injection was ideal (e.g. the clinician must decide with all of the evidence if the patient was infiltrated). We do not claim a percentage of radiopharmaceutical remaining at the injection site nor do we claim precision or accuracy measurements.

One of our customers at a clinical site would like to embark on a project with us. The customer would like to identify and track patients who have been significantly irradiated by infiltrations; goal would be to follow patients long-term for presentation of adverse tissue reactions. This would become part of the customer's patient follow-up process.

To identify the patients that would be followed, the customer would like my company to provide dosimetry measurements using the time activity curve data they collected using our device. Dosimetry is the measurement, calculation and assessment of ionizing radiation dose absorbed by an object, in this case, the object would be the person. This dosimetry measurement would be utilized as ground truth and would be the basis for following the patient.

Our labeling makes no current claims of being able to perform dosimetry calculations; we have not yet published anything on the subject (forthcoming). My company intends to teach the customer our methodology and base their decisions off of it.

Since following patients is already a process the customer performs, it's not a clinical study. However, my concern is with my company providing the dosimetry calculations. Are we overstepping our regulatory boundaries? The decision being made based on the calculation is only to follow a patient - it's not for patient disease management decisions.

Any help would be most appreciated.