Medical equipment Archives - Page 7 of 8

FDA Recommends New Testing Standards for Home Use Devices | RAPS

November 30, 2014

“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

October 1, 2014

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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 […]

HDMA – Issues in Distribution: Pharmaceutical Traceability and the Drug Supply Chain Security Act

September 8, 2014

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“The Drug Supply Chain Security Act (DSCSA, or Title II of the Drug Quality and Security Act) was enacted on November 27, 2013. The act replaces a 50-state patchwork of pedigree requirements with one federal traceability solution for prescription medicines, and raises licensure standards across the U.S. The law will transform how the domestic supply […]

Design Considerations for Devices Intended for Home Use – FDA Guidance

August 11, 2014

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Read the full guidance: Design Considerations for Devices Intended for Home Use – Guidance for Industry and Food and Drug Administration Staff (PDF – 205KB) As stated in the guidance, “This guidance is intended to assist manufacturers in designing and developing home use devices that comply with applicable standards of safety and effectiveness and other […]

CA Home Medical Device Retailer (HMDR) FAQs

June 23, 2014

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“The Home Medical Device Retailer (HMDR) licensing program is administered as part of the Medical Device Safety Section and is governed by law found in the California Sherman Food, Drug and Cosmetic Law. The Sherman Law was amended in the 1999-2000 legislative session to establish the HMDR licensing program. … Also found below is a link to […]

California HMDR Laws

June 6, 2014

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California HMDR Exemptee Training Certification Course for Home Medical Device Retailers (approved by the California Department of Public Health – Food and Drug Branch) “The Home Medical Device Retailer (HMDR) licensing program is administered as part of the Medical Device Safety Section and is governed by law found in the California Sherman Food, Drug and Cosmetic Law. […]