“They attributed the increase to growing pressure to expand services, increase geographic footprints and drive scale in specific markets. Consolidating firms will need to weather significant industry restructuring and navigate brand confusion in some markets, the report said. This year, meanwhile, respondents expected those large 2014 deals to lead to defensive acquisitions by other firms.” […]
Tag: certification
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 […]
New California Licenses Required For Third-Party Logistics Providers (3PLs)
This announcement was just sent by the California Board of Pharmacy: “Companies that do not own, but receive, store and ship prescription drugs and prescription devices into or within California need to obtain a third-party logistics provider (3PL) license immediately with the California State Board of Pharmacy. Formerly, these entities were licensed as wholesalers or nonresident wholesalers by […]
New Pharmacy Laws for 2015 – California Board of Pharmacy
Just posted, the CA Board of Pharmacy – California Law Changes for 2015 (PDF). It covers all code sections that were added or amended during the 2014 Legislative Session. Unless otherwise indicated, all of the provisions go into effect on January 1, 2015. Go to DREprof.com: The Designated Representative and Exemptee Training Website CA Designated […]
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 […]