FDA pathways, review timelines, and strategic decisions that shape your route to market.
An AI request stops your review clock. Here's how to respond completely, avoid a second AI, and get back to clearance as fast as possible.
A predicate dispute in an AI request or NSE determination isn't necessarily the end. Here's how to respond, when to pivot to a new predicate, and when to consider a different pathway.
A Pre-Sub can save months of rework — or waste weeks on questions FDA won't answer. Here's how to use Q-Subs effectively for 510(k) submissions.
Biocompatibility is one of the most common AI request triggers in 510(k) review. Here's how ISO 10993 applies to your device and how to build a defensible biocompatibility section.
Labeling deficiencies are the number one cause of Refuse to Accept decisions. Here's exactly what FDA requires in your 510(k) labeling — and how to keep it consistent.
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.