Guides on 510(k) predicate research, substantial equivalence, and FDA strategy — written for regulatory consultants and device founders.
A checklist for evaluating predicate candidates before you build a submission around them. Covers clearance fit, post-market history, enforcement record, and chain integrity.
MAUDE adverse event reports can reveal post-market problems with a predicate device before you commit to it. Here's how to use FDA's adverse event database in your predicate research.
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.
Every 510(k) predicate was itself cleared based on an earlier predicate. Tracing that lineage generation by generation can reveal risks your submission needs to address.
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.
Finding the right predicate is the most consequential decision in a 510(k) submission. A weak predicate choice delays clearance. Here's the systematic approach regulatory consultants actually use.
Section 4 is where your substantial equivalence argument lives. It's the section FDA reviewers read most carefully — and the one most likely to generate Additional Information requests when done poorly.
Most medical device companies assume 510(k) is the default FDA pathway. It often is — but not always. Understanding when a PMA is required, and when De Novo makes more sense, can save you years.
The three-letter product code assigned to your device determines its classification, regulation number, and predicate search strategy. Getting it right is foundational to a successful 510(k).
Substantial equivalence is the legal standard that makes 510(k) clearance possible. But FDA's definition is more nuanced than most device companies expect. Here's what reviewers actually evaluate.
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.
FDA's approach to regulating software-only medical devices has evolved rapidly. Here's what SaMD companies need to know before filing a 510(k) in 2026.
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.
FDA's 510(k) database contains 175,000+ clearances going back to 1976. Here's how to search it strategically — not just successfully.
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.