Here are a couple books that might interest HMDRs and HMDR Exemptees. Go to DREprof.com: The Designated Representative and Exemptee Training Website CA Designated Representative 3PL online web-based training certification by SkillsPlus Intl Inc. – NEW! CA Designated Representative online web-based training certification by SkillsPlus Intl Inc. – Available around-the-clock 24 x […]
Tag: Medical device
FDA’s Patient Preference Initiative: … | FDA Voice
This should interest HME professionals: “Last week we announced FDA’s first-ever Patient Engagement Advisory Committee, which will provide advice to the FDA Commissioner on complex issues relating to medical devices, the regulation of devices, and their use by patients. We thought it would be good to step back and fill you in about our Patient […]
FAQ: Who needs an HMDR License?
Exemptee: California HMDR Training Certification QUESTION: Who needs an HMDR license from the California Department of Public Health, Food and Drug Branch (CDPH/FDB)? ANSWER: Any person conducting an HMDR business (retail facility or warehouse) in the State of California must first obtain a license from CDPH/FDB. A separate license is required for each location. The […]
California HMDR Exemptee – Minimum Qualifications
California HMDR Exemptee Training Certification Course for home medical device retailers (accepted by the California Department of Public Health – Food and Drug Branch) Updated February 19, 2021: Many California Home Medical Device Retailer (HMDR) Exemptee applicants have questions about the minimum qualifications for Exemptee eligibility. If you navigate to, and open up the HMDR Exemptee Application (PDF), […]
FDA Recommends New Testing Standards for Home Use Devices | RAPS
“A final guidance document issued by the US Food and Drug Administration (FDA) aims to make medical devices used by patients in their homes safer and more reliable. Background In general, medical devices can be divided into two categories: Those intended to be used in professional settings by healthcare professionals, and those intended to be […]
Wishful Thinking?! Both Work Experience AND Training Are Required
This topic is coming up a lot lately. There appears to be confusion about whether work experience satisfies the training program requirement, or vice versa. In a nutshell, if you are applying for a California Designated Representative or Exemptee License, you’ll have to meet both the work experience requirement, and the training program requirement (i.e., completing […]