National Licensure Standards on Medical Devices Gains Momentum

FINAL Cures Discussion Document Section by SectionU.S. House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO) are leading the charge to establish a federal licensing standard on 3PLs and wholesalers handling medical devices—a policy that will mirror the same standards enacted on prescription drugs in the Drug Quality and Security Act.

The licensing on medical devices is only a small facet of the 21st Century Cures Initiative rolled out by the committee. Here are the goals as outlined during the Jan. 27 draft discussion:

  • incorporate patient perspectives into the regulatory process and help address their unmet medical needs;
  • build the foundation for 21st century medicine;
  • streamline clinical trials;
  • accelerate the discovery, development, and delivery cycle, and support continued innovation at federal public health agencies; and
  • modernize medical product regulation.

Two new concerns arise from all of this. The first legislation drafts ensured that federal licensing preempted any state licensing programs – just as the Drug Supply Chain Security Act (DSCSA) standard supersedes any state rules. Already several states are ignoring the federal law by enacting state licensing standards on pharmaceuticals: This adds more cost and complexity for 3PL compliance. It is unknown whether the issue will repeat itself for the medical device licensing.

Furthermore, the medical device list is quite extensive. IWLA members must take proper action in identifying products correctly if they are considered a medical device in the eyes of the U.S. Food and Drug Administration. They also must classify the risk level of the product to abide by the appropriate level of security. Stay tuned for more.

View the drafted bill Subtitle E–Supply Chain Security for Devices (Sections 5081-5088). 

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