FDA Recommends New Testing Standards for Home Use Devices | RAPS

FDA Logo for the CDRH“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 used in home healthcare settings by patients or caregivers.

The latter category, often referred to as “home use devices,” is associated with a unique set of concerns compared to its professional use counterparts. Because the devices are typically used frequently by those without medical training, FDA has taken an interest in making sure that they are designed appropriately for use within the home.”

Read the full article: via FDA Recommends New Testing Standards for Home Use Devices | RAPS.

Read the final FDA guidance:
Design Considerations for Devices Intended for Home Use – Guidance for Industry and Food and Drug Administration Staff (PDF)


Go to DREprof.com: The Designated Representative and Exemptee Training Website

Full-line distributor sales reached $305 billion in 2013, representing 90% of pharma sales – Pharmaceutical Commerce

Assorted drug capsules and tabletsHDMA’s 2014-15 Factbook updates member financial, operational performance.

The just-published 2014-15 Factbook, a compilation of HDMA member data as well as relevant industry statistics, gives evidence that full-line wholesalers are running faster—shipping more products each day, while handling a higher daily average of orders. The report also provides a snapshot of what the industry was looking like in 2013 just as the Drug Supply Chain Security Act was passed; presumably, the report from a year from now will show how ready the industry was for the Jan. 1, 2015, deadline coming up for reporting transaction information to customers and FDA, per DSCSA requirements. ”

Learn more details, read the full article: via Full-line distributor sales reached $305 billion in 2013, representing 90% of pharma sales – Pharmaceutical Commerce.


Go to DREprof.com: The Designated Representative and Exemptee Training Website

FDA Law Blog: FDA Speaks at Annual HDMA Track-and-Trace Conference

Workers in a warehouse“Throughout the conference, manufacturers, distributors, and other members of the drug supply chain expressed concern over the current lack of guidance from FDA regarding compliance with federal product tracing laws with only 49 days until the DSCSA is set to begin to take effect.

Dr. Connie Jung, Acting Associate Director for Policy and Communications for the Office of Drug Security, Integrity, and Recalls in FDA’s Center for Drug Evaluation and Research, Office of Compliance, once again spoke at the conference and attempted to address some of their concerns.”

Read the full report-out: via FDA Law Blog: FDA Speaks at Annual HDMA Track-and-Trace Conference.


Go to DREprof.com: The Designated Representative and Exemptee Training Website

It’s Holiday Season. Complete Designated Rep & Exemptee Training Before Year End!

Prepping vegetables in the kitchenThe holidays are coming!

Don’t let your Exemptee training or Designated Representative training hang over your head going into November and December.

Just get it done now, before:

  • the kids get out of school
  • you find yourself cooking in the kitchen
  • shopping for the holidays

Go to DREprof.com: The Designated Representative and Exemptee Training Website