Guides
Practitioner-level walkthroughs of FDA medical device regulation. Written plainly, without the marketing gloss that surrounds most of the public material on these topics.
- How 510(k) Clearance Works
Substantial equivalence, review timelines, the difference between clearance and approval, and the fields that actually matter when reading a 510(k) record.
- Understanding Predicate Devices
Predicates are the legal backbone of every 510(k). What they are, how they are chosen, how predicate chains form, and why reference devices are a different thing.
- Reading an FDA Recall Notice
A field guide to recall classes, lifecycle states, the fields worth reading first, and the difference between a recall, a market withdrawal, and a safety alert.