US FDA: 510(k)-Exempt Class II Devices Should Withdraw Applications
In line with the 21st Century Cures Act, US FDA has finalized a list of class II devices that will no longer need pre-market notification to get to market. Also, check out our updated Cures Act implementation table.
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US FDA Exempts 200 Device Types From Premarket Notification
The US FDA has finalized regulations exempting hundreds of class I and class II medical devices from premarket notification requirements.
5 Figures On 510(k) Exemptions: What's The Impact Of US FDA's Recent Actions?
The 21st Century Cures act requires FDA to identify devices to exempt from 510(k) review, a mandate the agency fulfilled earlier this year. But what will be the tangible impact of the hundreds of new device codes removed from 510(k) requirements? This graphical analysis, conducted in collaboration with regulatory intelligence specialist Graematter, shows the effect may not be as large as the top-line numbers suggest. But select specialties and companies may see a few meaningful burdens lifted.
Market Intel: Orthobiologics Market Well-Positioned For Innovative Reconstruction
Global sales of orthobiologics for musculoskeletal soft tissue replacement and regeneration are predicted to hit $1.4bn by 2021, driven largely by rising numbers of sports injuries requiring treatment, but also by a higher prevalence of osteoarthritis and a need for innovative treatments for musculoskeletal repair. This article offers an in-depth look at the orthobiologics market landscape for cartilage, meniscus and ligament/tendon replacement and regeneration, as well as insight from an orthopedic surgeon. It also analyzes key players in these markets and highlights emerging trends and the greatest barriers for wider adoption of products.