Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi,

is the registration on the FCC database mandatory?
My company is going to FDA certify an active medical device that transmits data via Bluetooth and Wi-Fi. For this reason we performed FCC tests but we did not submit these tests to the FCC in order to list our device on their database.

What do you think about?

Hi,
It really depends on your device and the type of telecommunications or radiocommunications transmitters or receivers used.  Also your devices intended use.  The FCC database is predominantly for radios/receivers contained in devices that require a license by rule.  For example devices that fall with CRF 47 Part 15 are considered unlicensed devices and only require compliance to the FCC Declaration of Conformity Equipment Authorization process. However, CFR 47 Part 95 (are Licensed by Rule) as well as Part 22, 24, and 27.  So depending on the above will help you determine if you are required to register in the FCC database.
Hope this helps,

------------------------------
[Monica] [Montanez] [MS RAC CQA]
[Principal Regulatory Affairs Specialist]
[NAMSA]
[Bailey [Colorado]
[USA]
------------------------------

Original Message:
Sent: 23-Sep-2021 04:15
From: Anonymous Member
Subject: FCC database registration for active medical device

This message was posted by a user wishing to remain anonymous

Hi,

is the registration on the FCC database mandatory?
My company is going to FDA certify an active medical device that transmits data via Bluetooth and Wi-Fi. For this reason we performed FCC tests but we did not submit these tests to the FCC in order to list our device on their database.

What do you think about?

Are there such rules for similar medical devices in the EU?

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

Original Message:
Sent: 24-Sep-2021 14:25
From: Monica Montanez
Subject: FCC database registration for active medical device

Hi,
It really depends on your device and the type of telecommunications or radiocommunications transmitters or receivers used.  Also your devices intended use.  The FCC database is predominantly for radios/receivers contained in devices that require a license by rule.  For example devices that fall with CRF 47 Part 15 are considered unlicensed devices and only require compliance to the FCC Declaration of Conformity Equipment Authorization process. However, CFR 47 Part 95 (are Licensed by Rule) as well as Part 22, 24, and 27.  So depending on the above will help you determine if you are required to register in the FCC database.
Hope this helps,

------------------------------
[Monica] [Montanez] [MS RAC CQA]
[Principal Regulatory Affairs Specialist]
[NAMSA]
[Bailey [Colorado]
[USA]

Original Message:
Sent: 23-Sep-2021 04:15
From: Anonymous Member
Subject: FCC database registration for active medical device

This message was posted by a user wishing to remain anonymous

Hi,

is the registration on the FCC database mandatory?
My company is going to FDA certify an active medical device that transmits data via Bluetooth and Wi-Fi. For this reason we performed FCC tests but we did not submit these tests to the FCC in order to list our device on their database.

What do you think about?

Yes. In EU your will need to be in compliance with RED 2014/53/EU: Radio Equipment Directive which replaced R &TTE Directive (1999/5/EC). Like the MDD you are to submit a submission and testing that meets the requirements of essential requirements to 2014/53/EU. Depending on the frequency there are many standards starting with ESTI EN XXX-XX and the requirement to perform EMC testing to name a few...Feel free in reaching out to me if you have any additional questions.

------------------------------
[Monica] [Montanez] [MS RAC CQA]
[Principal Product Development Strategist]
[NAMSA]
[Bailey [Colorado]
[USA]Principal Regulatory Product Development Strategist-Program DirectorPrincipal Regulatory Product Development Strategist-Program Director
------------------------------

Original Message:
Sent: 24-Sep-2021 16:52
From: Dan O'Leary
Subject: FCC database registration for active medical device

Are there such rules for similar medical devices in the EU?

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

Original Message:
Sent: 24-Sep-2021 14:25
From: Monica Montanez
Subject: FCC database registration for active medical device

Hi,
It really depends on your device and the type of telecommunications or radiocommunications transmitters or receivers used.  Also your devices intended use.  The FCC database is predominantly for radios/receivers contained in devices that require a license by rule.  For example devices that fall with CRF 47 Part 15 are considered unlicensed devices and only require compliance to the FCC Declaration of Conformity Equipment Authorization process. However, CFR 47 Part 95 (are Licensed by Rule) as well as Part 22, 24, and 27.  So depending on the above will help you determine if you are required to register in the FCC database.
Hope this helps,

------------------------------
[Monica] [Montanez] [MS RAC CQA]
[Principal Regulatory Affairs Specialist]
[NAMSA]
[Bailey [Colorado]
[USA]

Original Message:
Sent: 23-Sep-2021 04:15
From: Anonymous Member
Subject: FCC database registration for active medical device

This message was posted by a user wishing to remain anonymous

Hi,

is the registration on the FCC database mandatory?
My company is going to FDA certify an active medical device that transmits data via Bluetooth and Wi-Fi. For this reason we performed FCC tests but we did not submit these tests to the FCC in order to list our device on their database.

What do you think about?

I forgot to mention you need to submit your testing to FCC in order to be allowed to list in the database.  FCC issues the license # but great if they gave you a # without reviewing your testing.  Highly unlikely but possible.​​

------------------------------
[Monica] [Montanez] [MS RAC CQA]
[Principal Product Development Strategist]
[NAMSA]
[Bailey [Colorado]
[USA]Principal Regulatory ConsultantPrincipal Regulatory Consultant
------------------------------

Original Message:
Sent: 23-Sep-2021 04:15
From: Anonymous Member
Subject: FCC database registration for active medical device

This message was posted by a user wishing to remain anonymous

Hi,

is the registration on the FCC database mandatory?
My company is going to FDA certify an active medical device that transmits data via Bluetooth and Wi-Fi. For this reason we performed FCC tests but we did not submit these tests to the FCC in order to list our device on their database.

What do you think about?

This message was posted by a user wishing to remain anonymous

My experience with FCC, for a similar application to comply with part 15, is that you need certification. That declaration of conformity is not sufficient. FCC has guidances on this.

What I've never been clear on, even though I asked FDA's DICE, is whether the FCC certification is needed by FDA. It gets complicated, because FCC wants to see the manual, but FDA may change the manual.
Original Message:
Sent: 23-Sep-2021 04:15
From: Anonymous Member
Subject: FCC database registration for active medical device

This message was posted by a user wishing to remain anonymous

Hi,

is the registration on the FCC database mandatory?
My company is going to FDA certify an active medical device that transmits data via Bluetooth and Wi-Fi. For this reason we performed FCC tests but we did not submit these tests to the FCC in order to list our device on their database.

What do you think about?

Maybe we are getting confused on terminology so I will use the correct term as required under FCC.  Spectrum use for Part 15 - Radio Frequency devices are unlicensed and the requirement to to submit relevant documentation contained in the TDF to the Telecommunication Certification Body (TCB) is not required as long as your product testing or assessment to the FCC standard(s) demonstrating applicability of the Supplier's DoC process through part 15.201(a) for the product tested.  Applicability is demonstrated by test data or analysis indicating all emissions from the equipment under test are at least 40 dB below the limits specified in Part 15.209.

With regards to your question about FCC information needed by FDA.  I have not provided any of the testing performed for FCC to FDA with the exception of what is required according the FDA Guidance: Wireless Medical Devices.  

For FCC, whether a SDoC or certification under a Grantee, we  create a RF Brochure for FCC review which is specific to the radios/transmitters etc and not the medical device labeling.  In other words, FCC only is interested in the Telecommunications and EMC and FDA follows the guidance document for submission deliverables related to wireless medical devices.  
Hope this helps

------------------------------
[Monica] [Montanez] [MS RAC CQA]
[Principal Product Development Strategist]
[NAMSA]
[Bailey [Colorado]
[USA]Principal Regulatory Product Development Strategist-Program DirectorPrincipal Regulatory Product Development Strategist-Program Director
------------------------------

Original Message:
Sent: 25-Sep-2021 00:36
From: Anonymous Member
Subject: FCC database registration for active medical device

This message was posted by a user wishing to remain anonymous

My experience with FCC, for a similar application to comply with part 15, is that you need certification. That declaration of conformity is not sufficient. FCC has guidances on this.

What I've never been clear on, even though I asked FDA's DICE, is whether the FCC certification is needed by FDA. It gets complicated, because FCC wants to see the manual, but FDA may change the manual.
Original Message:
Sent: 23-Sep-2021 04:15
From: Anonymous Member
Subject: FCC database registration for active medical device

This message was posted by a user wishing to remain anonymous

Hi,

is the registration on the FCC database mandatory?
My company is going to FDA certify an active medical device that transmits data via Bluetooth and Wi-Fi. For this reason we performed FCC tests but we did not submit these tests to the FCC in order to list our device on their database.

What do you think about?

This message was posted by a user wishing to remain anonymous

I have understood the FCC regulations differently so I am eager if you could explain if I am off here.

The original poster said, "an active medical device that transmits data via Bluetooth and Wi-Fi". This sounds an "intentional radiator," based on https://www.fcc.gov/oet/ea/rfdevice which is what I have used. Based on https://www.fcc.gov/general/equipment-authorization-procedures#sec1, a supplier's Declaration of Conformity can NOT be used. It must be a certification, which is submitted to TCB. Which is what I've done. Therefore, I believe the original poster needs to submit to a TCB.
Original Message:
Sent: 27-Sep-2021 17:04
From: Monica Montanez
Subject: FCC database registration for active medical device

Maybe we are getting confused on terminology so I will use the correct term as required under FCC.  Spectrum use for Part 15 - Radio Frequency devices are unlicensed and the requirement to to submit relevant documentation contained in the TDF to the Telecommunication Certification Body (TCB) is not required as long as your product testing or assessment to the FCC standard(s) demonstrating applicability of the Supplier's DoC process through part 15.201(a) for the product tested.  Applicability is demonstrated by test data or analysis indicating all emissions from the equipment under test are at least 40 dB below the limits specified in Part 15.209.

With regards to your question about FCC information needed by FDA.  I have not provided any of the testing performed for FCC to FDA with the exception of what is required according the FDA Guidance: Wireless Medical Devices.

For FCC, whether a SDoC or certification under a Grantee, we  create a RF Brochure for FCC review which is specific to the radios/transmitters etc and not the medical device labeling.  In other words, FCC only is interested in the Telecommunications and EMC and FDA follows the guidance document for submission deliverables related to wireless medical devices.
Hope this helps

------------------------------
[Monica] [Montanez] [MS RAC CQA]
[Principal Product Development Strategist]
[NAMSA]
[Bailey [Colorado]
[USA]Principal Regulatory Product Development Strategist-Program DirectorPrincipal Regulatory Product Development Strategist-Program Director

Original Message:
Sent: 25-Sep-2021 00:36
From: Anonymous Member
Subject: FCC database registration for active medical device

This message was posted by a user wishing to remain anonymous

My experience with FCC, for a similar application to comply with part 15, is that you need certification. That declaration of conformity is not sufficient. FCC has guidances on this.

What I've never been clear on, even though I asked FDA's DICE, is whether the FCC certification is needed by FDA. It gets complicated, because FCC wants to see the manual, but FDA may change the manual.
Original Message:
Sent: 23-Sep-2021 04:15
From: Anonymous Member
Subject: FCC database registration for active medical device

This message was posted by a user wishing to remain anonymous

Hi,

is the registration on the FCC database mandatory?
My company is going to FDA certify an active medical device that transmits data via Bluetooth and Wi-Fi. For this reason we performed FCC tests but we did not submit these tests to the FCC in order to list our device on their database.

What do you think about?

I think that a supplier's DoC is sufficient if transmitters installed in the device already have their own FCC certification. Do you agree?

------------------------------
Andrea Duca
Roma
Italy
------------------------------

Original Message:
Sent: 27-Sep-2021 22:28
From: Anonymous Member
Subject: FCC database registration for active medical device

This message was posted by a user wishing to remain anonymous

I have understood the FCC regulations differently so I am eager if you could explain if I am off here.

The original poster said, "an active medical device that transmits data via Bluetooth and Wi-Fi". This sounds an "intentional radiator," based on https://www.fcc.gov/oet/ea/rfdevice which is what I have used. Based on https://www.fcc.gov/general/equipment-authorization-procedures#sec1, a supplier's Declaration of Conformity can NOT be used. It must be a certification, which is submitted to TCB. Which is what I've done. Therefore, I believe the original poster needs to submit to a TCB.
Original Message:
Sent: 27-Sep-2021 17:04
From: Monica Montanez
Subject: FCC database registration for active medical device

Maybe we are getting confused on terminology so I will use the correct term as required under FCC.  Spectrum use for Part 15 - Radio Frequency devices are unlicensed and the requirement to to submit relevant documentation contained in the TDF to the Telecommunication Certification Body (TCB) is not required as long as your product testing or assessment to the FCC standard(s) demonstrating applicability of the Supplier's DoC process through part 15.201(a) for the product tested.  Applicability is demonstrated by test data or analysis indicating all emissions from the equipment under test are at least 40 dB below the limits specified in Part 15.209.

With regards to your question about FCC information needed by FDA.  I have not provided any of the testing performed for FCC to FDA with the exception of what is required according the FDA Guidance: Wireless Medical Devices.

For FCC, whether a SDoC or certification under a Grantee, we  create a RF Brochure for FCC review which is specific to the radios/transmitters etc and not the medical device labeling.  In other words, FCC only is interested in the Telecommunications and EMC and FDA follows the guidance document for submission deliverables related to wireless medical devices.
Hope this helps

------------------------------
[Monica] [Montanez] [MS RAC CQA]
[Principal Product Development Strategist]
[NAMSA]
[Bailey [Colorado]
[USA]Principal Regulatory Product Development Strategist-Program DirectorPrincipal Regulatory Product Development Strategist-Program Director

Original Message:
Sent: 25-Sep-2021 00:36
From: Anonymous Member
Subject: FCC database registration for active medical device

This message was posted by a user wishing to remain anonymous

My experience with FCC, for a similar application to comply with part 15, is that you need certification. That declaration of conformity is not sufficient. FCC has guidances on this.

What I've never been clear on, even though I asked FDA's DICE, is whether the FCC certification is needed by FDA. It gets complicated, because FCC wants to see the manual, but FDA may change the manual.
Original Message:
Sent: 23-Sep-2021 04:15
From: Anonymous Member
Subject: FCC database registration for active medical device

This message was posted by a user wishing to remain anonymous

Hi,

is the registration on the FCC database mandatory?
My company is going to FDA certify an active medical device that transmits data via Bluetooth and Wi-Fi. For this reason we performed FCC tests but we did not submit these tests to the FCC in order to list our device on their database.

What do you think about?

Disagree.

------------------------------
[Monica] [Montanez] [MS RAC CQA]
[Principal Product Development Strategist]
[NAMSA]
[Bailey [Colorado]
[USA]Principal Regulatory Product Development Strategist-Program DirectorPrincipal Regulatory Product Development Strategist-Program Director
------------------------------

Original Message:
Sent: 28-Sep-2021 05:41
From: Andrea Duca
Subject: FCC database registration for active medical device

I think that a supplier's DoC is sufficient if transmitters installed in the device already have their own FCC certification. Do you agree?

------------------------------
Andrea Duca
Roma
Italy

Original Message:
Sent: 27-Sep-2021 22:28
From: Anonymous Member
Subject: FCC database registration for active medical device

This message was posted by a user wishing to remain anonymous

I have understood the FCC regulations differently so I am eager if you could explain if I am off here.

The original poster said, "an active medical device that transmits data via Bluetooth and Wi-Fi". This sounds an "intentional radiator," based on https://www.fcc.gov/oet/ea/rfdevice which is what I have used. Based on https://www.fcc.gov/general/equipment-authorization-procedures#sec1, a supplier's Declaration of Conformity can NOT be used. It must be a certification, which is submitted to TCB. Which is what I've done. Therefore, I believe the original poster needs to submit to a TCB.
Original Message:
Sent: 27-Sep-2021 17:04
From: Monica Montanez
Subject: FCC database registration for active medical device

Maybe we are getting confused on terminology so I will use the correct term as required under FCC.  Spectrum use for Part 15 - Radio Frequency devices are unlicensed and the requirement to to submit relevant documentation contained in the TDF to the Telecommunication Certification Body (TCB) is not required as long as your product testing or assessment to the FCC standard(s) demonstrating applicability of the Supplier's DoC process through part 15.201(a) for the product tested.  Applicability is demonstrated by test data or analysis indicating all emissions from the equipment under test are at least 40 dB below the limits specified in Part 15.209.

With regards to your question about FCC information needed by FDA.  I have not provided any of the testing performed for FCC to FDA with the exception of what is required according the FDA Guidance: Wireless Medical Devices.

For FCC, whether a SDoC or certification under a Grantee, we  create a RF Brochure for FCC review which is specific to the radios/transmitters etc and not the medical device labeling.  In other words, FCC only is interested in the Telecommunications and EMC and FDA follows the guidance document for submission deliverables related to wireless medical devices.
Hope this helps

------------------------------
[Monica] [Montanez] [MS RAC CQA]
[Principal Product Development Strategist]
[NAMSA]
[Bailey [Colorado]
[USA]Principal Regulatory Product Development Strategist-Program DirectorPrincipal Regulatory Product Development Strategist-Program Director

Original Message:
Sent: 25-Sep-2021 00:36
From: Anonymous Member
Subject: FCC database registration for active medical device

This message was posted by a user wishing to remain anonymous

My experience with FCC, for a similar application to comply with part 15, is that you need certification. That declaration of conformity is not sufficient. FCC has guidances on this.

What I've never been clear on, even though I asked FDA's DICE, is whether the FCC certification is needed by FDA. It gets complicated, because FCC wants to see the manual, but FDA may change the manual.
Original Message:
Sent: 23-Sep-2021 04:15
From: Anonymous Member
Subject: FCC database registration for active medical device

This message was posted by a user wishing to remain anonymous

Hi,

is the registration on the FCC database mandatory?
My company is going to FDA certify an active medical device that transmits data via Bluetooth and Wi-Fi. For this reason we performed FCC tests but we did not submit these tests to the FCC in order to list our device on their database.

What do you think about?

I agree a SDoc can not be used for a medical device that transmits data via Bluetooth and Wi-Fi.  What determines the process is the radio/transmitters spectrum use!!!!!  the Bluetooth component in the medical device uses a frequency band that normally falls under Part 95 (again depending what type of bluetooth component is in use, (note: there are various types of Bluetooth components that use an array of frequencies).
The supplier Doc is only applicable to devices that have 175kHz radios and these radios can be used in active implantable devices.  This type of radio will be measured for radiated power level against the general requirement in Part 15.209 to ensure the radiated fields is low enough to allow for FCC verification instead of full verification. Bluetooth devices do not fall into the category, however some medical devices may have both types of radios so you could have a SDoC and certification in one active implantable device depending on intended use.

Feel free to reach out to me if you have a need for RF consulting for Medical Devices. My email is listed below.

------------------------------
[Monica] [Montanez] [MS RAC CQA]
[Principal Product Development Strategist]
[NAMSA]
[Bailey [Colorado]
[mmontanez@namsa.com]
------------------------------

Original Message:
Sent: 27-Sep-2021 22:28
From: Anonymous Member
Subject: FCC database registration for active medical device

This message was posted by a user wishing to remain anonymous

I have understood the FCC regulations differently so I am eager if you could explain if I am off here.

The original poster said, "an active medical device that transmits data via Bluetooth and Wi-Fi". This sounds an "intentional radiator," based on https://www.fcc.gov/oet/ea/rfdevice which is what I have used. Based on https://www.fcc.gov/general/equipment-authorization-procedures#sec1, a supplier's Declaration of Conformity can NOT be used. It must be a certification, which is submitted to TCB. Which is what I've done. Therefore, I believe the original poster needs to submit to a TCB.
Original Message:
Sent: 27-Sep-2021 17:04
From: Monica Montanez
Subject: FCC database registration for active medical device

Maybe we are getting confused on terminology so I will use the correct term as required under FCC.  Spectrum use for Part 15 - Radio Frequency devices are unlicensed and the requirement to to submit relevant documentation contained in the TDF to the Telecommunication Certification Body (TCB) is not required as long as your product testing or assessment to the FCC standard(s) demonstrating applicability of the Supplier's DoC process through part 15.201(a) for the product tested.  Applicability is demonstrated by test data or analysis indicating all emissions from the equipment under test are at least 40 dB below the limits specified in Part 15.209.

With regards to your question about FCC information needed by FDA.  I have not provided any of the testing performed for FCC to FDA with the exception of what is required according the FDA Guidance: Wireless Medical Devices.

For FCC, whether a SDoC or certification under a Grantee, we  create a RF Brochure for FCC review which is specific to the radios/transmitters etc and not the medical device labeling.  In other words, FCC only is interested in the Telecommunications and EMC and FDA follows the guidance document for submission deliverables related to wireless medical devices.
Hope this helps

------------------------------
[Monica] [Montanez] [MS RAC CQA]
[Principal Product Development Strategist]
[NAMSA]
[Bailey [Colorado]
[USA]Principal Regulatory Product Development Strategist-Program DirectorPrincipal Regulatory Product Development Strategist-Program Director

Original Message:
Sent: 25-Sep-2021 00:36
From: Anonymous Member
Subject: FCC database registration for active medical device

This message was posted by a user wishing to remain anonymous

My experience with FCC, for a similar application to comply with part 15, is that you need certification. That declaration of conformity is not sufficient. FCC has guidances on this.

What I've never been clear on, even though I asked FDA's DICE, is whether the FCC certification is needed by FDA. It gets complicated, because FCC wants to see the manual, but FDA may change the manual.
Original Message:
Sent: 23-Sep-2021 04:15
From: Anonymous Member
Subject: FCC database registration for active medical device

This message was posted by a user wishing to remain anonymous

Hi,

is the registration on the FCC database mandatory?
My company is going to FDA certify an active medical device that transmits data via Bluetooth and Wi-Fi. For this reason we performed FCC tests but we did not submit these tests to the FCC in order to list our device on their database.

What do you think about?