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

Combination Product Designations At US FDA Need Faster Appeals, Petition Says

 
• By Michael Cipriano

No sponsor is named in the citizen petition, but it was filed on behalf of an applicant that has had a designation-decision appeal "under consideration" for 18 months and counting.

A new citizen petition says US FDA's Office of Combination Products (OCP) should establish timelines for appeals of designation decisions, citing "significant delays" in FDA reviews and in responses to challenges by companies to designations of products deemed to have a drug or biological primary mode of action.

The petition dated March 3 does not name a sponsor. It was filed on behalf of a client...

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

Injuries And Deaths Linked To Baxter Infusion Pump

 
• By Brian Bossetta

The US FDA says Baxter has notified customers about an issue with its Novum IQ Syringe Pump that is linked to two deaths and multiple injuries.

Novel Pathway For Combined Drug/IVD Trials Wins Backing Of EU Nations

 
• By Vibha Sharma

Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.

New Draft Guidance Clarifies FDA’s UDI Rules For Combination Products

 
• By Elizabeth Orr

The FDA has released draft guidance clarifying UDI rules for drug- and device-led combination products. The document specifies labeling requirements and makes recommendations to reduce confusion between UDIs and NDCs. Comments are being accepted until Sept. 24.

European Commission Asks For ‘Open Minds’ On Unified Drug/Device Research Pathway

 
• By Vibha Sharma

As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.

More from Device Area

FDA Ends Effort To Regulate LDTs By Rescinding Final Rule

 
• By Brian Bossetta

Just a year and four months after publishing a final rule that would have allowed it to regulate laboratory developed tests as medical devices, the US FDA has rescinded the controversial measure, finally putting an end to the saga.

Exact Sciences Reveals Thinking On CRC Liquid Biopsy After Freenome Deal

 
• By Natasha Barrow

Exact Sciences has entered into an exclusive licensing agreement with Freenome, stipulating clinical benchmarks and a first-line rating in the USPSTF guidelines. Medtech Insight interviewed screening CMO Paul Limburg about CRC screening and Exact’s strategy on liquid biopsy.

Fresh Off $100M IPO, Carlsmed Plans For Growth, 2026 Launch Of Customized Cervical Fusion Implant

 
• By Marion Webb

Fresh off an IPO, spinal implant maker Carlsmed is preparing to launch a new cervical fusion application for its aprevo tech. Medtech Insight has two perspectives on these recent moves: CEO Mike Cordonnier and the doctor who performed the first spinal fusion using the technology.