FDA pathways, review timelines, and strategic decisions that shape your route to market.
A checklist for evaluating predicate candidates before you build a submission around them. Covers clearance fit, post-market history, enforcement record, and chain integrity.
A predicate applicant's FDA warning letter history can affect the strength of your 510(k) submission. Here's what warning letters reveal and how to factor them into predicate selection.
FDA's view of a device type doesn't stop at clearance. Enforcement actions in the years after clearance reveal how regulators think about a device's risks in practice.
Most medical device companies assume 510(k) is the default FDA pathway. It often is — but understanding when a PMA is required, and when De Novo makes more sense, can save you years.
FDA has a 90-day statutory review goal for 510(k)s. Most submissions take longer. Here's what actually drives the timeline — and what you control.
De Novo isn't a fallback when you can't find a predicate — it's a strategic pathway for novel devices that creates regulatory precedent for an entire product category.
Combination products occupy some of the most complex regulatory territory FDA administers. Understanding primary mode of action and lead center assignment is essential before you file.