FDA Device Guidance Agenda 2027: What Medtech Teams Should Plan For
CDRH's fiscal 2027 list puts AI software, change control plans and robotic surgery at the top. Here is what each item means for your next submission and budget.
Tech Business Town
Author
Health and agritech editor
12+ years experience
Nkem Adeyemi edits the medtech and agritech desks. A biomedical engineer by training, she worked in quality and regulatory roles at two device makers before moving into reporting, and grew up on a mixed farm that still argues about yield maps.
CDRH's fiscal 2027 list puts AI software, change control plans and robotic surgery at the top. Here is what each item means for your next submission and budget.
Nkem Adeyemi · · 7 min read
Putting different amounts of seed, fertilizer or lime on different parts of a field sounds like big-farm technology. The economics depend on your fields, not your acreage.
Nkem Adeyemi · · 7 min read
Founders new to medtech are often surprised by how long the road is from working prototype to hospital purchase. Most of that time is evidence, not engineering.
Nkem Adeyemi · · 10 min read
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