Here are five things to know:
1. The FDA granted 38 premarket approvals to innovative devices, down 51 percent from 2015. The agency took 18.1 months to announce approval, compared with 17.3 months in 2015.
2. The 21st Century Cures Act went into effect in 2016, relaxing the approval criteria for medical devices, which could contribute to faster decisions and more approvals in the future.
3. Innovation slowdown could be another reason for fewer approvals as the large companies are finding fewer innovative technologies to acquire.
4. There were six humanitarian device exemptions in 2015 but none in 2016. The 21st Century Cures Act expands the number of patients HDE-approved devices can treat from 4,000 to 8,000 patients per year and speeds up the review process.
5. Cardiology had the most products approved last year and the fastest approval was Medtronic’s Minimed 670G system, which took 3.4 months to receive approval. On average it took orthopedic devices 37.8 months to receive approval.
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