Regulatory Open Forum

Could a manufacturer of class II devices, who sells products in U.S. only, offer IFUs on a website (ie. eIFU) ?
I understand that there is no guidance from FDA; I have heard here and there that guidance will be available within next 6 months or less.

If a URL is set up that is compliant with the EU guidance and manufacturer also offers printed copies free of charge, at request, with same day - 48 hours turn around, would it be acceptable ?

------------------------------
Robert Nami
Carlsbad CA
United States
------------------------------

Short answer: yes.

------------------------------
Sarah Parsons RAC
Associate Director Regulatory Affairs
Janssen R&D
Pittsford NY
United States
------------------------------

Original Message:
Sent: 24-May-2017 18:12
From: Robert Nami
Subject: eIFU

Could a manufacturer of class II devices, who sells products in U.S. only, offer IFUs on a website (ie. eIFU) ?
I understand that there is no guidance from FDA; I have heard here and there that guidance will be available within next 6 months or less.

If a URL is set up that is compliant with the EU guidance and manufacturer also offers printed copies free of charge, at request, with same day - 48 hours turn around, would it be acceptable ?

------------------------------
Robert Nami
Carlsbad CA
United States
------------------------------

What would be the 2-3 areas/issues of concern if any?

------------------------------
Robert Nami
Carlsbad CA
United States
------------------------------

Original Message:
Sent: 25-May-2017 07:58
From: Sarah Parsons
Subject: eIFU

Short answer: yes.

------------------------------
Sarah Parsons RAC
Associate Director Regulatory Affairs
Janssen R&D
Pittsford NY
United States
------------------------------

Original Message:
Sent: 24-May-2017 18:12
From: Robert Nami
Subject: eIFU

Could a manufacturer of class II devices, who sells products in U.S. only, offer IFUs on a website (ie. eIFU) ?
I understand that there is no guidance from FDA; I have heard here and there that guidance will be available within next 6 months or less.

If a URL is set up that is compliant with the EU guidance and manufacturer also offers printed copies free of charge, at request, with same day - 48 hours turn around, would it be acceptable ?

------------------------------
Robert Nami
Carlsbad CA
United States
------------------------------

Hi Robert,

• Prior to March 31, 2003, FDA required all labeling for devices be provided in 'paper form'.Section 206 of MDUFMA amended Section 502(f) of the Federal Food, Drug, and Cosmetic Act to authorize the use of electronic labeling in US
• Product Eligibility for eIFU: Prescription devices, intended for use within the confines of a health care facility are eligible for electronic labeling. Users should have the opportunity to request the labeling in paper form and companies should promptly provide such labeling to customers without additional cost. Over-the-counter (OTC) devices and Rx devices intended for home use are not eligible for eIFU.
• If you already have the Class II device on the market, you do not need to submit a new 510k to FDA provided the only change you are making is from paper to electronic IFU. You should consider addressing the eIFU as a part of an original 510k or design change submission.
• You will need to consider the V&V activities while designing the eIFU platform. This includes a lot of work like website functionality, customer service training, procedures, risk assessment, label update to include eiFU symbol, web browser compatibility, security & privacy features, etc.

While eIFU is definitely a lucrative option, it is does require a lot of work. One needs to evaluate the benefits before making such a decision.


------------------------------
[Shiven]
[Regulatory Affairs]
[San Francisco] [CA]
------------------------------

Original Message:
Sent: 25-May-2017 12:00
From: Robert Nami
Subject: eIFU

What would be the 2-3 areas/issues of concern if any?

------------------------------
Robert Nami
Carlsbad CA
United States
------------------------------

Original Message:
Sent: 25-May-2017 07:58
From: Sarah Parsons
Subject: eIFU

Short answer: yes.

------------------------------
Sarah Parsons RAC
Associate Director Regulatory Affairs
Janssen R&D
Pittsford NY
United States
------------------------------

Original Message:
Sent: 24-May-2017 18:12
From: Robert Nami
Subject: eIFU

Could a manufacturer of class II devices, who sells products in U.S. only, offer IFUs on a website (ie. eIFU) ?
I understand that there is no guidance from FDA; I have heard here and there that guidance will be available within next 6 months or less.

If a URL is set up that is compliant with the EU guidance and manufacturer also offers printed copies free of charge, at request, with same day - 48 hours turn around, would it be acceptable ?

------------------------------
Robert Nami
Carlsbad CA
United States
------------------------------

Dear Shiven,

Thank you very much for the thorough, clear and informative response to my post.

------------------------------
Robert Nami
Carlsbad CA
United States
------------------------------

Original Message:
Sent: 26-May-2017 13:39
From: Shiven Gandhi
Subject: eIFU

Hi Robert,

• Prior to March 31, 2003, FDA required all labeling for devices be provided in 'paper form'.Section 206 of MDUFMA amended Section 502(f) of the Federal Food, Drug, and Cosmetic Act to authorize the use of electronic labeling in US
• Product Eligibility for eIFU: Prescription devices, intended for use within the confines of a health care facility are eligible for electronic labeling. Users should have the opportunity to request the labeling in paper form and companies should promptly provide such labeling to customers without additional cost. Over-the-counter (OTC) devices and Rx devices intended for home use are not eligible for eIFU.
• If you already have the Class II device on the market, you do not need to submit a new 510k to FDA provided the only change you are making is from paper to electronic IFU. You should consider addressing the eIFU as a part of an original 510k or design change submission.
• You will need to consider the V&V activities while designing the eIFU platform. This includes a lot of work like website functionality, customer service training, procedures, risk assessment, label update to include eiFU symbol, web browser compatibility, security & privacy features, etc.

While eIFU is definitely a lucrative option, it is does require a lot of work. One needs to evaluate the benefits before making such a decision.


------------------------------
[Shiven]
[Regulatory Affairs]
[San Francisco] [CA]
------------------------------

Original Message:
Sent: 25-May-2017 12:00
From: Robert Nami
Subject: eIFU

What would be the 2-3 areas/issues of concern if any?

------------------------------
Robert Nami
Carlsbad CA
United States
------------------------------

Original Message:
Sent: 25-May-2017 07:58
From: Sarah Parsons
Subject: eIFU

Short answer: yes.

------------------------------
Sarah Parsons RAC
Associate Director Regulatory Affairs
Janssen R&D
Pittsford NY
United States
------------------------------

Original Message:
Sent: 24-May-2017 18:12
From: Robert Nami
Subject: eIFU

Could a manufacturer of class II devices, who sells products in U.S. only, offer IFUs on a website (ie. eIFU) ?
I understand that there is no guidance from FDA; I have heard here and there that guidance will be available within next 6 months or less.

If a URL is set up that is compliant with the EU guidance and manufacturer also offers printed copies free of charge, at request, with same day - 48 hours turn around, would it be acceptable ?

------------------------------
Robert Nami
Carlsbad CA
United States
------------------------------

For CLIA-moderate products, you can supply the IFUs only in electronic format, unless a customer requests a paper copy.

------------------------------
Ajay Bhatia
Salt Lake City UT
United States
------------------------------

Original Message:
Sent: 24-May-2017 18:12
From: Robert Nami
Subject: eIFU

Could a manufacturer of class II devices, who sells products in U.S. only, offer IFUs on a website (ie. eIFU) ?
I understand that there is no guidance from FDA; I have heard here and there that guidance will be available within next 6 months or less.

If a URL is set up that is compliant with the EU guidance and manufacturer also offers printed copies free of charge, at request, with same day - 48 hours turn around, would it be acceptable ?

------------------------------
Robert Nami
Carlsbad CA
United States
------------------------------

To add to Ajay's comment, you also need to be mindful that you have followed the 2016 rule on symbology. To provide the IFU electronically you need to put on the labeling that the IFU can be found at a web address. How you do that and be compliant to the symbols rule has some manufacturers scratching their heads, but it can be done.

------------------------------
Sarah Parsons RAC
Director Regulatory Affairs
Janssen R&D
Pittsford NY
United States
------------------------------

Original Message:
Sent: 25-May-2017 14:52
From: Ajay Bhatia
Subject: eIFU

For CLIA-moderate products, you can supply the IFUs only in electronic format, unless a customer requests a paper copy.

------------------------------
Ajay Bhatia
Salt Lake City UT
United States
------------------------------

Original Message:
Sent: 24-May-2017 18:12
From: Robert Nami
Subject: eIFU

Could a manufacturer of class II devices, who sells products in U.S. only, offer IFUs on a website (ie. eIFU) ?
I understand that there is no guidance from FDA; I have heard here and there that guidance will be available within next 6 months or less.

If a URL is set up that is compliant with the EU guidance and manufacturer also offers printed copies free of charge, at request, with same day - 48 hours turn around, would it be acceptable ?

------------------------------
Robert Nami
Carlsbad CA
United States
------------------------------

Original Message------

Could a manufacturer of class II devices, who sells products in U.S. only, offer IFUs on a website (ie. eIFU) ?
I understand that there is no guidance from FDA; I have heard here and there that guidance will be available within next 6 months or less.

If a URL is set up that is compliant with the EU guidance and manufacturer also offers printed copies free of charge, at request, with same day - 48 hours turn around, would it be acceptable ?

------------------------------
Robert Nami
Carlsbad CA
United States
------------------------------

Thank you David.  Very useful info.

------------------------------
Robert Nami
Carlsbad CA
United States
------------------------------

Original Message:
Sent: 29-May-2017 20:59
From: David Lim
Subject: eIFU

Robert,

It is worth noting Medical Devices Technical Corrections Act (MDTCA), amending MDUFMA 2002 and expanding the elabeling provision. FDA summary of MDTCA is attached for your convenience. 

The MDTCA extends the elabeling provision of 502(f) of the FDCA. 

For example:

Prescription devices used by a health care professional, regardless of the setting in which the device is used. MDUMFA authorized electronic labeling only when the prescription device is used in a health care facility.

 

In vitro diagnostic devices used by a health care professional, regardless of the setting in which the device is used. This clarification removes any doubt as to whether in vitro diagnostic devices qualify for electronic labeling.

Please refer to the table titled "When May Electronic Labeling Be Used?"

Thank you.

s/ David

______________________________________________

Dr. David Lim, Ph.D., RAC, ASQ-CQA 

REGULATORY DOCTOR

http://www.regulatorydoctor.US

Phone (Toll-Free): 1-(800) 321-8567

E-mail:  David@RegulatoryDoctor.US

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