Regulatory Open Forum

Hello again Gabriela,

Title 21 of the United States Code (U.S.C.) section 352 allows for the distribution of prescription device labeling solely by electronic means as long as the manufacturer provides access to paper labeling upon request at no additional cost.  Specifically, this U.S. statutory provision establishes that required labeling for prescription devices intended for use in health care facilities or by a health care professional (as well as for in vitro diagnostic devices intended for use by health care professionals or in blood establishments) may be made available solely by electronic means, provided that the labeling complies with all applicable requirements of U.S. law.  In such cases, the manufacturer must also afford users the opportunity to request the labeling in paper form, and after such request, must promptly provide the requested information without additional cost.

Note that the statute does not prescribe or restrict what type of electronic media is used to provide such electronic labeling.  Yet in today's cybersecurity environment, you should still be sure that the healthcare facility will allow the use of outside computer accessories (such as USB drives) that could be used on the facility's networked computers.

A couple of other important points:

Remember that instructions for use (IFU), including the media on which they are provided, are part of the FDA Device Master Record (DMR).  So be sure that any electronic IFU are properly incorporated into the device's DMR.  This means specifications not only for the IFU content, but also for the electronic medium itself, procedures for copying the electronic IFU onto the media (this is a manufacturing operation), and for the associated quality control inspections/verifications and release.

And when design controls apply, remember also that the electronic media and IFU thereon are design outputs, thus requiring traceability to corresponding upstream design inputs along with downstream design verification, validation, transfer, and change control.

Hello again Gabriela,

Title 21 of the United States Code (U.S.C.) section 352 allows for the distribution of prescription device labeling solely by electronic means as long as the manufacturer provides access to paper labeling upon request at no additional cost.  Specifically, this U.S. statutory provision establishes that required labeling for prescription devices intended for use in health care facilities or by a health care professional (as well as for in vitro diagnostic devices intended for use by health care professionals or in blood establishments) may be made available solely by electronic means, provided that the labeling complies with all applicable requirements of U.S. law.  In such cases, the manufacturer must also afford users the opportunity to request the labeling in paper form, and after such request, must promptly provide the requested information without additional cost.

Note that the statute does not prescribe or restrict what type of electronic media is used to provide such electronic labeling.  Yet in today's cybersecurity environment, you should still be sure that the healthcare facility will allow the use of outside computer accessories (such as USB drives) that could be used on the facility's networked computers.

A couple of other important points:

Remember that instructions for use (IFU), including the media on which they are provided, are part of the FDA Device Master Record (DMR).  So be sure that any electronic IFU are properly incorporated into the device's DMR.  This means specifications not only for the IFU content, but also for the electronic medium itself, procedures for copying the electronic IFU onto the media (this is a manufacturing operation), and for the associated quality control inspections/verifications and release.

And when design controls apply, remember also that the electronic media and IFU thereon are design outputs, thus requiring traceability to corresponding upstream design inputs along with downstream design verification, validation, transfer, and change control.

Good follow-up questions.

Section 352, entitled "Misbranded drugs and devices" includes devices in its scope, going on to address devices directly therein some 43 times.  So, we can be confident in applying section 352 to medical devices.  For example, subsection 352(f) is the provision specifically addressing electronic labeling for prescription devices.

Subsection 352(f) as written isn't class-specific, and I'm unaware of any limitation therein prohibiting its application to class III implantable devices.  Nonetheless, in addition to appropriately scaled quality system coverage (e.g., design controls, DMR, etc.; see my initial post in this thread), I would recommend that the premarket notification or premarket approval application (whichever is applicable) clearly address the Sponsor's intent to provide eIFU pursuant to the eIFU statute.  That way, the agency has fair opportunity to raise objections at the premarket stage, yet would be compelled to do so against the statutory weight and intent of subsection 352(f).

Hello again Gabriela,

Title 21 of the United States Code (U.S.C.) section 352 allows for the distribution of prescription device labeling solely by electronic means as long as the manufacturer provides access to paper labeling upon request at no additional cost.  Specifically, this U.S. statutory provision establishes that required labeling for prescription devices intended for use in health care facilities or by a health care professional (as well as for in vitro diagnostic devices intended for use by health care professionals or in blood establishments) may be made available solely by electronic means, provided that the labeling complies with all applicable requirements of U.S. law.  In such cases, the manufacturer must also afford users the opportunity to request the labeling in paper form, and after such request, must promptly provide the requested information without additional cost.

Note that the statute does not prescribe or restrict what type of electronic media is used to provide such electronic labeling.  Yet in today's cybersecurity environment, you should still be sure that the healthcare facility will allow the use of outside computer accessories (such as USB drives) that could be used on the facility's networked computers.

A couple of other important points:

Remember that instructions for use (IFU), including the media on which they are provided, are part of the FDA Device Master Record (DMR).  So be sure that any electronic IFU are properly incorporated into the device's DMR.  This means specifications not only for the IFU content, but also for the electronic medium itself, procedures for copying the electronic IFU onto the media (this is a manufacturing operation), and for the associated quality control inspections/verifications and release.

And when design controls apply, remember also that the electronic media and IFU thereon are design outputs, thus requiring traceability to corresponding upstream design inputs along with downstream design verification, validation, transfer, and change control.

Good follow-up questions.

Section 352, entitled "Misbranded drugs and devices" includes devices in its scope, going on to address devices directly therein some 43 times.  So, we can be confident in applying section 352 to medical devices.  For example, subsection 352(f) is the provision specifically addressing electronic labeling for prescription devices.

Subsection 352(f) as written isn't class-specific, and I'm unaware of any limitation therein prohibiting its application to class III implantable devices.  Nonetheless, in addition to appropriately scaled quality system coverage (e.g., design controls, DMR, etc.; see my initial post in this thread), I would recommend that the premarket notification or premarket approval application (whichever is applicable) clearly address the Sponsor's intent to provide eIFU pursuant to the eIFU statute.  That way, the agency has fair opportunity to raise objections at the premarket stage, yet would be compelled to do so against the statutory weight and intent of subsection 352(f).

Hello again Gabriela,

Title 21 of the United States Code (U.S.C.) section 352 allows for the distribution of prescription device labeling solely by electronic means as long as the manufacturer provides access to paper labeling upon request at no additional cost.  Specifically, this U.S. statutory provision establishes that required labeling for prescription devices intended for use in health care facilities or by a health care professional (as well as for in vitro diagnostic devices intended for use by health care professionals or in blood establishments) may be made available solely by electronic means, provided that the labeling complies with all applicable requirements of U.S. law.  In such cases, the manufacturer must also afford users the opportunity to request the labeling in paper form, and after such request, must promptly provide the requested information without additional cost.

Note that the statute does not prescribe or restrict what type of electronic media is used to provide such electronic labeling.  Yet in today's cybersecurity environment, you should still be sure that the healthcare facility will allow the use of outside computer accessories (such as USB drives) that could be used on the facility's networked computers.

A couple of other important points:

Remember that instructions for use (IFU), including the media on which they are provided, are part of the FDA Device Master Record (DMR).  So be sure that any electronic IFU are properly incorporated into the device's DMR.  This means specifications not only for the IFU content, but also for the electronic medium itself, procedures for copying the electronic IFU onto the media (this is a manufacturing operation), and for the associated quality control inspections/verifications and release.

And when design controls apply, remember also that the electronic media and IFU thereon are design outputs, thus requiring traceability to corresponding upstream design inputs along with downstream design verification, validation, transfer, and change control.

Good follow-up questions.

Section 352, entitled "Misbranded drugs and devices" includes devices in its scope, going on to address devices directly therein some 43 times.  So, we can be confident in applying section 352 to medical devices.  For example, subsection 352(f) is the provision specifically addressing electronic labeling for prescription devices.

Subsection 352(f) as written isn't class-specific, and I'm unaware of any limitation therein prohibiting its application to class III implantable devices.  Nonetheless, in addition to appropriately scaled quality system coverage (e.g., design controls, DMR, etc.; see my initial post in this thread), I would recommend that the premarket notification or premarket approval application (whichever is applicable) clearly address the Sponsor's intent to provide eIFU pursuant to the eIFU statute.  That way, the agency has fair opportunity to raise objections at the premarket stage, yet would be compelled to do so against the statutory weight and intent of subsection 352(f).

Hello again Gabriela,

Title 21 of the United States Code (U.S.C.) section 352 allows for the distribution of prescription device labeling solely by electronic means as long as the manufacturer provides access to paper labeling upon request at no additional cost.  Specifically, this U.S. statutory provision establishes that required labeling for prescription devices intended for use in health care facilities or by a health care professional (as well as for in vitro diagnostic devices intended for use by health care professionals or in blood establishments) may be made available solely by electronic means, provided that the labeling complies with all applicable requirements of U.S. law.  In such cases, the manufacturer must also afford users the opportunity to request the labeling in paper form, and after such request, must promptly provide the requested information without additional cost.

Note that the statute does not prescribe or restrict what type of electronic media is used to provide such electronic labeling.  Yet in today's cybersecurity environment, you should still be sure that the healthcare facility will allow the use of outside computer accessories (such as USB drives) that could be used on the facility's networked computers.

A couple of other important points:

Remember that instructions for use (IFU), including the media on which they are provided, are part of the FDA Device Master Record (DMR).  So be sure that any electronic IFU are properly incorporated into the device's DMR.  This means specifications not only for the IFU content, but also for the electronic medium itself, procedures for copying the electronic IFU onto the media (this is a manufacturing operation), and for the associated quality control inspections/verifications and release.

And when design controls apply, remember also that the electronic media and IFU thereon are design outputs, thus requiring traceability to corresponding upstream design inputs along with downstream design verification, validation, transfer, and change control.

Given the very short, direct, plain-language nature of the subsection 352(f) eIFU provision (it's only one sentence in length), I don't expect FDA to supplement it with an implementing regulation.  Such a regulation would seem hard pressed to find additional content or parameters beyond that which is already embodied by this simple law, which just states,

"...Required labeling for prescription devices intended for use in health care facilities or by a health care professional and required labeling for in vitro diagnostic devices intended for use by health care professionals or in blood establishments may be made available solely by electronic means, provided that the labeling complies with all applicable requirements of law, and that the manufacturer affords such users the opportunity to request the labeling in paper form, and after such request, promptly provides the requested information without additional cost..."

In light of the brevity of this provision, FDA probably believes (and I agree) that it wouldn't be the best use of FDA and public bandwidth to endure the U.S. regulatory promulgation process for this particular law.

FDA's Blue Book Memo #G03-1 (many thanks to Richard for attaching it) is intended specifically for the agency's premarket submission reviewers and that scope of work.  Yet after wading through some overcomplicating and irrelevant narratives (like its history narrative and its use of the term "distributors"), we as submission Sponsors can certainly glean some great insights regarding premarket preparation and submission tactics echoing what I distilled in my prior posts in this thread.  In the end, informal non-statutory / non-regulatory documents like this would seem to be sufficient in lieu of regulatory promulgation for short, direct statutes like FDA's medical device eIFU law.

Good follow-up questions.

Section 352, entitled "Misbranded drugs and devices" includes devices in its scope, going on to address devices directly therein some 43 times.  So, we can be confident in applying section 352 to medical devices.  For example, subsection 352(f) is the provision specifically addressing electronic labeling for prescription devices.

Subsection 352(f) as written isn't class-specific, and I'm unaware of any limitation therein prohibiting its application to class III implantable devices.  Nonetheless, in addition to appropriately scaled quality system coverage (e.g., design controls, DMR, etc.; see my initial post in this thread), I would recommend that the premarket notification or premarket approval application (whichever is applicable) clearly address the Sponsor's intent to provide eIFU pursuant to the eIFU statute.  That way, the agency has fair opportunity to raise objections at the premarket stage, yet would be compelled to do so against the statutory weight and intent of subsection 352(f).

Hello again Gabriela,

Title 21 of the United States Code (U.S.C.) section 352 allows for the distribution of prescription device labeling solely by electronic means as long as the manufacturer provides access to paper labeling upon request at no additional cost.  Specifically, this U.S. statutory provision establishes that required labeling for prescription devices intended for use in health care facilities or by a health care professional (as well as for in vitro diagnostic devices intended for use by health care professionals or in blood establishments) may be made available solely by electronic means, provided that the labeling complies with all applicable requirements of U.S. law.  In such cases, the manufacturer must also afford users the opportunity to request the labeling in paper form, and after such request, must promptly provide the requested information without additional cost.

Note that the statute does not prescribe or restrict what type of electronic media is used to provide such electronic labeling.  Yet in today's cybersecurity environment, you should still be sure that the healthcare facility will allow the use of outside computer accessories (such as USB drives) that could be used on the facility's networked computers.

A couple of other important points:

Remember that instructions for use (IFU), including the media on which they are provided, are part of the FDA Device Master Record (DMR).  So be sure that any electronic IFU are properly incorporated into the device's DMR.  This means specifications not only for the IFU content, but also for the electronic medium itself, procedures for copying the electronic IFU onto the media (this is a manufacturing operation), and for the associated quality control inspections/verifications and release.

And when design controls apply, remember also that the electronic media and IFU thereon are design outputs, thus requiring traceability to corresponding upstream design inputs along with downstream design verification, validation, transfer, and change control.