Guides on 510(k) predicate research, substantial equivalence, and FDA strategy — written for regulatory consultants and device founders.
A complete checklist covering all eSTAR sections — from device description to performance testing. Know exactly what FDA expects before you file.
Device classification determines your regulatory pathway. Here's what Class I, II, and III mean — and how classification affects predicate selection and submission requirements.
Both 510(k) and De Novo lead to market for Class II devices. The right choice depends on whether a valid predicate exists — and the strategic value of establishing a new device type.
IVD 510(k)s follow the same substantial equivalence framework but have unique predicate requirements, analytical validation expectations, and labeling rules.
Not every cleared device can serve as your predicate. FDA has specific requirements for what counts as legally marketed — and using an invalid one wastes months.
The FDA 510(k) database has 175,000+ records — but the default search interface misses a lot. Here's how to search more effectively and find predicates FDA's tool won't surface.
A single predicate often can't carry the full substantial equivalence argument. Here's when multiple predicates are appropriate — and how FDA evaluates them.
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 — and how to keep it consistent across your entire submission.
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.
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.
The three-letter product code assigned to your device determines its classification, regulation number, and predicate search strategy. Getting it right is foundational.
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.
Substantial equivalence is the legal standard that makes 510(k) clearance possible. But FDA's definition is more nuanced than most device companies expect.
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.