A few quick notes I wanted to post while clearing my inbox of my "informative reading" emails from last week:

  • Through the agreement between Australian and New Zealand governments for medical device regulation, ANZTPA (Australia New Zealand Therapeutic Products Agency) released a description of a joint regulatory scheme of therapeutic products. It can be found here at ANZTPA's website.
  • According to the New England Journal of Medicine, as summarized by an article published by RAPS.org, a regulatory "loophole" is allowing unsafe devices to reach patients. The culprit? Class III devices that were originally allowed to be approved through 510(k) after the Medical Device Amendments regulation in 1976 which have not been transitioned to PMA approval. The article points to metal-on-metal hip implants as an example.
  • PathWise has a free White Paper available for download on how to prepare for an FDA inspection. The download can be found here.

Happy Monday!

-RTK

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