1. Medtech Insight
  2. >>Business
  3. >>Strategy

FDA Tackles 3-D Printing Considerations In Draft Guidance

A draft guidance issued by FDA on additive manufacturing, or 3-D printing, of medical devices is meant to be a starting point for an industry that is growing exponentially. The document outlines recommendations on topics such as device design, software considerations and material testing requirements.

FDA has published a draft leapfrog guidance on 3-D printing that draws from a 2014 agency workshop on the topic. The guidance outlines key issues manufacturers should think about when designing products made with 3-D printers, including the materials used to make those devices and considerations when planning devices specific to individual 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
Start Free Trial

Already a subscriber?

More from Strategy

Diagnostics Are Essential, But How Can Companies Ensure A Fair Price?

 
• By Barnaby Pickering

Biotech and pharma are increasingly clear about one thing: They need diagnostics. But with prices suppressed, how have diagnostics companies proven their utility without going under?

Enovis Appoints Damien McDonald CEO, Reaffirms Q1 Guidance Amid Strategic Growth Push

 
• By Marion Webb

Enovis has named veteran medtech leader Damien McDonald as its new CEO effective 12 May as the orthopedic company reaffirms first-quarter 2025 revenue guidance of between $555m and $563m. Medtech Insight spoke with Tim Czartoski, Enovis’ president of US surgical and global product and enabling technologies, about the firm’s growth strategy and innovation plans.

THENA Capital ‘Makes History’ As UK’s First All-Female Early-Stage Medtech Fund

 
• By Natasha Barrow

Only 16% of venture capital general partners in Europe are women, and only 9% of those have actual investment power. Thena Capital is aiming to "redefine the image of a venture capitalist."

More from Business

‘Preparing For Regulatory Milestones, Commercial Launch’ Are Priorities, Says New Freenome CEO Aaron Elliott

 
• By Marion Webb

Freenome plans to file for US FDA approval of its blood-based screening test for colorectal cancer mid-year. If cleared, the test would rival Guardant Health’s Shield, the first FDA-cleared blood test for primary screening of colorectal cancer. Exact Sciences is also in the race to bring a blood-based colorectal screening test to market.

Biotech Leader Predicts Delays On Device Approvals As FDA Makes Life-Saving Drugs Sole Priority

 
• By Natasha Barrow

Nawal Ouzren, Sensorion CEO and director, shared the latest industry reaction to US FDA layoffs at the McDermott Will & Emery European Health and Life Sciences Symposium in Paris.

LSI 2025: Egg Medical Builds ‘Nests’ Around Interventional Cardiologists To Protect Against Scatter Radiation

 
• By Marion Webb

Egg Medical is ramping up efforts to expand international sales of its EggNest scatter radiation protection system to shield X-ray procedure room staff without disrupting workflow. Medtech Insight sat down with Bob Wilson, Egg Medical’s CEO, to discuss the various EggNest systems, marketing opportunities and the competitive landscape.