FDA To Hold Postponed 3-Day Pediatric Device Workshop In February
The US agency plans to hold a virtual workshop that will use breakout sessions to get stakeholder feedback on specific hurdles preventing more pediatric devices coming to market.
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While the US FDA has been developing a framework over the past few years to address the lack of pediatric devices on the market, the agency awarded a grant to the multi-stakeholder group C-Path to continue that work at the same time that the coronavirus pandemic started. Despite the hurdles, C-Path says it is still doing its work and plans to convene a public meeting on the issue in September.
At a recent pediatric medical devices workshop at US FDA headquarters, the focus turned less to regulatory burdens and more to lacking reimbursement and financial incentives as barriers to bringing child-focused products to market.
The US FDA and ECRI released four reports about the safety of certain materials used in medical devices. While the risks seem to be comparatively low, they note the quality of literature is lacking to make broad evaluations.