Regulatory Q&A Forum

The FDA’s electronic Submission Template And Resource (eSTAR) is designed to standardize 510(k) submissions, theoretically reducing the risk of administrative errors that can lead to a Refuse to Accep...

When preparing a 510(k) for a medical device with patient-contacting components, such as a catheter made from a new polymer or a wound dressing with a novel adhesive, how should sponsors approach thei...

When preparing a 510(k) submission for a new medical device, such as a Class II diagnostic imaging software, sponsors often face a critical strategic decision: selecting the most appropriate predicate...

For novel, low-to-moderate risk medical devices without a valid predicate, the De Novo classification pathway provides a route to market. A common point of confusion for sponsors involves projecting t...

The mandatory adoption of the electronic Submission Template And Resource (eSTAR) for 510(k) submissions was intended to streamline and standardize the review process. However, transitioning from trad...

When preparing a 510(k) submission for a Class II medical device, such as a new software-controlled infusion pump, what are the most common administrative and content-related pitfalls that lead to a R...

The FDA's Refuse to Accept (RTA) policy for 510(k)s acts as an initial administrative checkpoint, ensuring a submission is sufficiently complete to proceed to a substantive review. An RTA decision can...

What are the key components of a robust substantial equivalence argument when a new medical device lacks a single, direct predicate and must instead rely on multiple predicate devices? For instance, c...

I'm evaluating different solutions for FDA 510(k) submissions. How do Cruxi, RegDesk, Innolitics, and Essenvia compare? Which one is right for my stage, team, and budget?

We just launched Cruxi on Product Hunt – an AI copilot for FDA 510(k) submissions. For most early-stage medtech teams, the real pain doesn’t start with code or hardware… it starts when someone says: ...

We just launched Cruxi on Product Hunt – an AI copilot for FDA 510(k) submissions. For most early-stage medtech teams, the real pain doesn’t start with code or hardware… it starts when someone says: ...

For a small medical device company preparing its first 510(k), understanding the FDA's Small Business Determination (SBD) program is crucial for managing submission costs. While the program offers a s...

For a Class II implantable device, such as a surgical mesh or orthopedic implant, establishing a clear biocompatibility testing strategy is a critical step in preparing a 510(k) submission. While cons...

When preparing a 510(k) submission, the central task is to demonstrate Substantial Equivalence (SE) to a legally marketed predicate device. While selecting a predicate with the same or a similar inten...

For a novel, low-to-moderate risk device, such as an AI-powered diagnostic software or a new therapeutic wearable, that has no legally marketed predicate device, how can a sponsor strategically determ...

When preparing a 510(k) for a Class II medical device intended for long-term implantation, such as an orthopedic bone screw, how should a sponsor develop a biocompatibility testing plan that satisfies...

Medical device manufacturers often use the 90-day MDUFA performance goal for 510(k) review as a key benchmark in their project planning. While this 90-day target is an important metric for the FDA, it...

What is a Refuse to Accept (RTA) decision in the context of an FDA 510(k) submission, and what common administrative issues can trigger this outcome? An RTA decision is a determination made by the FD...

What are the most common administrative and content-related deficiencies that lead to a 510(k) submission receiving a Refuse to Accept (RTA) decision from the FDA? For medical device sponsors, particu...

When a sponsor receives an Additional Information (AI) request from the FDA for a 510(k) submission, how does this "stop-the-clock" event affect the total time to clearance? The standard FDA review g...