Exhaustive Extractions

At iuvo, we work hard to stay on the cutting edge of new developments in testing and regulatory changes affecting the medical device and pharmaceutical industries. We will share these updates regularly here in our blog - Exhaustive Extractions.

Recent FDA Announcements - Accessories and Least Burdensome Provisions

There's frequently a flurry of FDA announcement near the end of the year, and this year was no exception.  We wanted to highlight a couple of the more pertinent ones that may be of interest to our customers.  The summaries below link to some of the more interesting guidance documents recently released.

  • In late December, the FDA announced the availability of updated final guidance entitled "Medical Device Accessories – Describing Accessories and Classification Pathways."  This guidance was updated to include new mechanisms to request a different classification for an existing accessory type and for new accessory types which are cleared for marketing under a 510(k) or PMA.
  • Also in December, the FDA issued a new guidance related to teh Least Burdensome Provisions entitled "The Least Burdensome Provisions: Concept and Principles."  The guidance provides some useful insights into the FDAs current thinking on the Least Burdensome Approach as enacted in the FDA Modernization Act of 1997.

 

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Thursday, 20 June 2019
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