FDA on Medical Devices In The Home

• California HMDR Exemptee Training Certification Course for home medical device retailers (accepted by the California Department of Public Health - Food and Drug Branch)

Updated July 31, 2024

The link in the original post broke.

You might also be interested in:

• The FDA's Home Use Devices Initiative
• FDA Additional Resources on Home Use Devices (includes educational tools)

- - -  the original post follows below  - - -

The FDA added FDA's Home Use Medical Device Initiative -  Online Training Courses.

This is important, for the following reasons:

• Home care trends
• Agency's interest in home use medical device safety
• Risks associated with home use
• FDA's Home Use Initiative
• FDA's Actions

Return Home:  The Designated Representative and Exemptee Blog

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California HMDR Exemptee Training Certification Course for home medical device retailers (accepted by the California Department of Public Health - Food and Drug Branch)

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

For HME Users - Booklet To Prepare For Power Outages

Updated July 26, 2026

Check out this useful booklet (PDF) from the FDA and CDRH:  Home Use Devices: How to Prepare for and Handle Power Outages for Medical Devices that Require Electricity, 

Return Home:  The Designated Representative and Exemptee Blog

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

News On FDA Home Use Device Initiative

• Recommended FDA GMP online training courses sold by SkillsPlus International Inc.
• California HMDR Exemptee license training certification course for home medical device retailers - Learn more - Buy now!

Updated March 8, 2026

Links broke in the original post.

You can still read about the topic here:
FDA Home Use Devices Initiative Webpage

- - - original post below - - -

The FDAnews reports, "The FDA may suggest devicemakers create different written instructions for the patient, prescriber of the device and the person training the consumer on how to use the device, Mary Weick-Brady, a senior policy analyst at CDRH, said."

New sets of instructions for patient, prescriber, and trainer will have ramifications for home care providers.

Learn more about the FDA Home Use Device Initiative:

• FDA to Address Challenges of Using Complex Medical Devices in the Home
• FDA Medical Device Home Use Initiative (pdf)

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