1. Medtech Insight
  2. >>Digital Technologies

Legislation Would Streamline Risk-Classification For Device Accessories

A bill introduced in the US that industry stakeholders want to be added to the "must-pass" user-fee reauthorization bill would create a tailored approach to classifying or reclassifying device accessories, following up on change made last year that requires accessories to be classified separately from parent devices. Streamlining accessory oversight has been an industry goal, particularly of health-software makers.

Following provisions in the 21st Century Cures Act to separate US FDA review of accessories from their parent device, a bill proposed in the US House would create a new streamlined regulatory pathway for accessories. The bill is being hailed by industry lobbyists as an "important legislation" that would save the agency resources while stopping regulators from unfairly categorizing the products.

Device-industry advocates hope to add the legislation, which was introduced in the House and referred to the House Energy and...

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 Digital Technologies

After Thought-Control Demo, Synchron Plans Pilot Study With Upgraded BCI On Path To Pivotal Trial

 
• By Marion Webb

Synchron is preparing a pilot study of its fully wireless, second-gen brain-computer interface after an ALS patient controlled an iPad solely by thought. If all goes as planned, Synchron’s BCI will move into pivotal trials in 2026.

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.

HistoSonics Sells Majority Stake To Investor Syndicate In Deal Valued At $2.25Bn

 
• By Marion Webb

HistoSonics’ CEO Michael Blue describes the deal as a win-win for all stakeholders and plans to use the money to expand clinical indications, as well as the global reach, for its Edison system.

More from Medtech Insight

After Thought-Control Demo, Synchron Plans Pilot Study With Upgraded BCI On Path To Pivotal Trial

 
• By Marion Webb

Synchron is preparing a pilot study of its fully wireless, second-gen brain-computer interface after an ALS patient controlled an iPad solely by thought. If all goes as planned, Synchron’s BCI will move into pivotal trials in 2026.

Apreo Health Raises $130M, First Patient Treated In US Clinical Trial

 
• By Natasha Barrow

Apreo Health CEO Karun Naga talks to Medtech Insight about the company’s intentions for its Series B funding. The Breathe-3 clinical trial and early commercialization activities, involving physician education, are top priorities.

Execs On The Move: August 4–8, 2025

 
• By Medtech Insight Team

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.