FDA Draft Guidance: How To Claim Humanitarian Device Status

Firms must document that humanitarian devices target a rare disease or condition, or a small subset of a common disease or condition, the draft explains.

FDA issued draft guidance Dec. 13 to help manufacturers prepare requests for “humanitarian-use device” designation, a necessary first step in submitting pre-market applications for products intended for small populations of patients.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Regulation

More from Policy & Regulation