“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 […]
Tag: Medical device
Design Considerations for Devices Intended for Home Use – FDA Guidance
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
“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
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. […]
Prolonged Power Outages Can Be Deadly for People Who Rely on Durable Medical Equipment | Huffington Post
“Already this year, American communities have experienced floods, tornadoes and wildfires. Our country needs a better way to protect medically fragile people so natural disasters don’t become medical emergencies. Thousands of people in the United States rely on electrically powered DME to meet their medical needs at home. While they can manage their medical conditions […]
Medicare to expand ‘prior authorization’ for device coverage | TheHill
“In a shift from the current system, Medicare is proposing to rule on seniors’ coverage for home medical devices before the supplies are delivered or claims for payment are submitted. The Centers for Medicare and Medicaid Services CMS is planning to expand the use of “prior authorization” for power scooters and wheelchairs, and introduce the […]