Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

What kind of DHF format is advisable for a class I, minor level of concern, SAMD? Please share best practices.

This message was posted by a user wishing to remain anonymous

Hi, 

 Here is the guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-premarket-submissions-software-contained-medical-devices

For all levels of concerns, you are expected to have the same content in the DHF (e.g. software requirements specification, traceability, revision level of history); no prescribed format.
Original Message:
Sent: 07-Jun-2019 01:45
From: Anonymous Member
Subject: DHF

This message was posted by a user wishing to remain anonymous

What kind of DHF format is advisable for a class I, minor level of concern, SAMD? Please share best practices.

There is no defined structure for a DHF, this really depends on the company, design and development process, documentation practices, and record management.  Reviewing many companies have never seen a DHF that is the same - so structure against 21 CFR Part 820.30, ISO 13485:2016 Section 7.3, and as the previous person posted the FDA guidance document on software contained in a submission.  This guidance document is quite nice because it talks about things like SRS, SDS, architecture, etc.  However, keep in mind this FDA guidance document is only for software documentation, design controls contain other elements such as design review, development planning, design transfer, etc.  And do not forget about cybersecurity !  Sharing best practices for a DHF would be unable to post in this short forum, but there are many papers and information out there about DHFs.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 07-Jun-2019 15:11
From: Anonymous Member
Subject: DHF

This message was posted by a user wishing to remain anonymous

Hi,

 Here is the guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-premarket-submissions-software-contained-medical-devices

For all levels of concerns, you are expected to have the same content in the DHF (e.g. software requirements specification, traceability, revision level of history); no prescribed format.
Original Message:
Sent: 07-Jun-2019 01:45
From: Anonymous Member
Subject: DHF

This message was posted by a user wishing to remain anonymous

What kind of DHF format is advisable for a class I, minor level of concern, SAMD? Please share best practices.

I agree with Richard. Ive seen dozens of company DHFs and not one looked the same as another. It totally depends on how you want to store the information. There are many best practices out there. If you are still uncertain after reading the suggested guidance and other resources available, I suggest reaching out to a regulatory consultant who can help you set up a DHF that is appropriate for your device and compliant.

------------------------------
Carrie Kuehn, MA, MPH, LPD, RAC
Principal Consultant & Founder
Evergreen Strategic Consulting
carrie.kuehn@esc-strategic.com
United States
------------------------------

Original Message:
Sent: 07-Jun-2019 01:45
From: Anonymous Member
Subject: DHF

This message was posted by a user wishing to remain anonymous

What kind of DHF format is advisable for a class I, minor level of concern, SAMD? Please share best practices.

Hello, Anonymous.

IEC 62304 is what you are looking for.

------------------------------
Michael Reents
Bradenton FL
United States
------------------------------

Original Message:
Sent: 07-Jun-2019 01:45
From: Anonymous Member
Subject: DHF

This message was posted by a user wishing to remain anonymous

What kind of DHF format is advisable for a class I, minor level of concern, SAMD? Please share best practices.

This message was posted by a user wishing to remain anonymous

Thanks to all for suggestions. I would also like to confirm if a DHF would be required for a Medical Device Data System. The MDDS  guidance mentions the FDA does not intend to enforce compliance with the regulatory controls including quality system regulations.

It will be very helpful if someone with MDDS experience can share their knowledge about level of documentation required.

Original Message:
Sent: 10-Jun-2019 16:36
From: Michael Reents
Subject: DHF

Hello, Anonymous.

IEC 62304 is what you are looking for.

------------------------------
Michael Reents
Bradenton FL
United States

Original Message:
Sent: 07-Jun-2019 01:45
From: Anonymous Member
Subject: DHF

This message was posted by a user wishing to remain anonymous

What kind of DHF format is advisable for a class I, minor level of concern, SAMD? Please share best practices.

Hello again, Anonymous.

You ask if a DHF is required for an MDDS. I will answer with a question. Required by whom? FDA places no requirements on MDDS. Perhaps your customers?

We have MDDS items but still voluntarily comply with IEC 62304 almost to the level of safety class B. I think just good software engineering practices would require: revision control (software development plan), issue tracking (software development plan), documented requirements/specifications (software requirements specification document), and documented traceable verification for each released version (verification records and software release notes).


------------------------------
Michael Reents
Bradenton FL
United States
------------------------------

Original Message:
Sent: 11-Jun-2019 20:48
From: Anonymous Member
Subject: DHF

This message was posted by a user wishing to remain anonymous

Thanks to all for suggestions. I would also like to confirm if a DHF would be required for a Medical Device Data System. The MDDS  guidance mentions the FDA does not intend to enforce compliance with the regulatory controls including quality system regulations.

It will be very helpful if someone with MDDS experience can share their knowledge about level of documentation required.

Original Message:
Sent: 10-Jun-2019 16:36
From: Michael Reents
Subject: DHF

Hello, Anonymous.

IEC 62304 is what you are looking for.

------------------------------
Michael Reents
Bradenton FL
United States

Original Message:
Sent: 07-Jun-2019 01:45
From: Anonymous Member
Subject: DHF

This message was posted by a user wishing to remain anonymous

What kind of DHF format is advisable for a class I, minor level of concern, SAMD? Please share best practices.

With the 21st Century Cures Act, MDDS is no longer considered to be a medical device (it was excluded from the definition see FDCA § 520(o)(1)(D))

------------------------------
Michael Zagorski RAC
Pittsburgh PA
------------------------------

Original Message:
Sent: 11-Jun-2019 20:48
From: Anonymous Member
Subject: DHF

This message was posted by a user wishing to remain anonymous

Thanks to all for suggestions. I would also like to confirm if a DHF would be required for a Medical Device Data System. The MDDS  guidance mentions the FDA does not intend to enforce compliance with the regulatory controls including quality system regulations.

It will be very helpful if someone with MDDS experience can share their knowledge about level of documentation required.

Original Message:
Sent: 10-Jun-2019 16:36
From: Michael Reents
Subject: DHF

Hello, Anonymous.

IEC 62304 is what you are looking for.

------------------------------
Michael Reents
Bradenton FL
United States

Original Message:
Sent: 07-Jun-2019 01:45
From: Anonymous Member
Subject: DHF

This message was posted by a user wishing to remain anonymous

What kind of DHF format is advisable for a class I, minor level of concern, SAMD? Please share best practices.

I have a standalone-software MDDS client working towards ISO 13485 registration since their customers are "requiring" it. From the broader worldwide perspective, their product is considered a health software product per IEC 82304-1, and 82304-1 directly points to the medical device software standard IEC 62304 for several of the requirements. So...even though some health software products may not be regulated as medical devices, depending on the jurisdiction (region/country), there is still a strong connection to the 62304 medical device software standard.

ISO 13485 allows the exclusion of design controls if it can be justified. However, for standalone-software products, I cannot imagine how it could be justified.
Any thoughts on this?

For more color on FDA perspectives on MDDS, go here.

------------------------------
Sam Lazzara
Medical Device Quality Consultant
San Francisco Bay Area, California USA
https://mdqc.blog
------------------------------

Original Message:
Sent: 13-Jun-2019 15:11
From: Michael Zagorski
Subject: DHF

With the 21st Century Cures Act, MDDS is no longer considered to be a medical device (it was excluded from the definition see FDCA @ 520(o)(1)(D))

------------------------------
Michael Zagorski RAC
Pittsburgh PA

Original Message:
Sent: 11-Jun-2019 20:48
From: Anonymous Member
Subject: DHF

This message was posted by a user wishing to remain anonymous

Thanks to all for suggestions. I would also like to confirm if a DHF would be required for a Medical Device Data System. The MDDS  guidance mentions the FDA does not intend to enforce compliance with the regulatory controls including quality system regulations.

It will be very helpful if someone with MDDS experience can share their knowledge about level of documentation required.

Original Message:
Sent: 10-Jun-2019 16:36
From: Michael Reents
Subject: DHF

Hello, Anonymous.

IEC 62304 is what you are looking for.

------------------------------
Michael Reents
Bradenton FL
United States

Original Message:
Sent: 07-Jun-2019 01:45
From: Anonymous Member
Subject: DHF

This message was posted by a user wishing to remain anonymous

What kind of DHF format is advisable for a class I, minor level of concern, SAMD? Please share best practices.

I agree with Richard.

------------------------------
Kuldeep Tyagi
CEO
Ghaziabad
India
------------------------------

Original Message:
Sent: 07-Jun-2019 01:45
From: Anonymous Member
Subject: DHF

This message was posted by a user wishing to remain anonymous

What kind of DHF format is advisable for a class I, minor level of concern, SAMD? Please share best practices.