Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello Colleagues,

Do you have any recommendations for training resources that provide an overview of the similarities and differences between CDER and CDRH and their regulatory pathways for employees transitioning from pharmaceutical organizations to medical devices (specifically SaMD)? An overview of the submission types, submission standards, best practices for working with the Agency, etc. would all be helpful.

I appreciate any recommendations.

Hi,

You could check FDA's "CDRH Learn" page here. It covers a good variety of topics.

Kind regards,
Korina

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Korina Anagnostou
Leiden
Netherlands
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Original Message:
Sent: 10-Jan-2022 10:25
From: Anonymous Member
Subject: CDRH vs CDER Training Resources

This message was posted by a user wishing to remain anonymous

Hello Colleagues,

Do you have any recommendations for training resources that provide an overview of the similarities and differences between CDER and CDRH and their regulatory pathways for employees transitioning from pharmaceutical organizations to medical devices (specifically SaMD)? An overview of the submission types, submission standards, best practices for working with the Agency, etc. would all be helpful.

I appreciate any recommendations.

Hello,

I agree with Korina, CDRH Learn has a wealth of information.  CDER unfortunately does not have anything too comprehensive, but there are a couple https://www.fda.gov/training-and-continuing-education/cderlearn-training-and-education/general-courses.  There other area you can review is when FDA publishes guidance documents, they record the webinar which goes through the guidance documents like https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/medical-device-webinars-and-stakeholder-calls and https://www.fda.gov/drugs/cder-webinars.  Also CDER SBIA has frequent seminars, even 1 or 2 days long, on different topics which an excellent source of current CDER topics and plus if register properly can get CEUs from these https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/cder-small-business-and-industry-assistance-sbia-learn.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 11-Jan-2022 03:27
From: Korina Anagnostou
Subject: CDRH vs CDER Training Resources

Hi,

You could check FDA's "CDRH Learn" page here. It covers a good variety of topics.

Kind regards,
Korina

------------------------------
Korina Anagnostou
Leiden
Netherlands

Original Message:
Sent: 10-Jan-2022 10:25
From: Anonymous Member
Subject: CDRH vs CDER Training Resources

This message was posted by a user wishing to remain anonymous

Hello Colleagues,

Do you have any recommendations for training resources that provide an overview of the similarities and differences between CDER and CDRH and their regulatory pathways for employees transitioning from pharmaceutical organizations to medical devices (specifically SaMD)? An overview of the submission types, submission standards, best practices for working with the Agency, etc. would all be helpful.

I appreciate any recommendations.

This message was posted by a user wishing to remain anonymous

I don't know that if I've seen much comparing them, because they are so, so, different. However, 2 great resources are:

- FDA's CDRHLearn: https://www.fda.gov/training-and-continuing-education/cdrh-learn 
- Greenlight Guru's free resources (webinars, podcasts, eBooks, articles, templates): https://www.greenlight.guru/medical-device-resources
- The Device Track on FDA's REdI conferences in 2019 or 2020 (not 2021 as it was mostly focused on COVID)

There's enough really outstanding, FREE material on those sites to occupy you the rest of 2022! For employees in my groups who come from the drug site, I have actually created an pharma to SaMD training plan composed of free resources mostly from those 3 sources.

Another recommendation is to learn the principles and history behind medical device regulation. An informative, but rather dry article, is called Substantial Equivalence Premarket Review: the Right Approach for Most Medical Devices by Jeffrey K. Shapiro at https://hpm.com/wp-content/uploads/2014/09/shapirofdlivolume69issue3.pdf .The articles it not my training plan because I don't think my audience has the patience to read it, but if you do, you'll have a much better grasp of the foundational differences.
Original Message:
Sent: 10-Jan-2022 10:25
From: Anonymous Member
Subject: CDRH vs CDER Training Resources

This message was posted by a user wishing to remain anonymous

Hello Colleagues,

Do you have any recommendations for training resources that provide an overview of the similarities and differences between CDER and CDRH and their regulatory pathways for employees transitioning from pharmaceutical organizations to medical devices (specifically SaMD)? An overview of the submission types, submission standards, best practices for working with the Agency, etc. would all be helpful.

I appreciate any recommendations.