1. Medtech Insight
  2. >>Device Area
  3. >>Combination Products

FDA Draft Guidance Urges Consistency, Plain Language In Combo Product Instructions

 
• By Elizabeth Orr

A new draft guidance document from the US agency offers nuts-and-bolts guidance on formatting Instructions for Use (IFUs) for drug-device and biologic-device combination product applications.

Drugstore customer
An IFU is a component of combination product labeling that helps consumers access treatment

Instructions for Use (IFUs) for combination products should use clear, concise and nontechnical language whenever possible to help ensure they’re useful to patients, the US Food and Drug Administration says in a new draft guidance that includes specific wording recommendations.

The 20-page document applies to drug-device and biologic-device products that are submitted to the FDA under a new drug application (NDA) or a biologics license application (BLA), and is being issued to address a

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
Start Free Trial

Already a subscriber?

More from Combination Products

More from Device Area