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.