Regulatory Q&A Forum

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...

For companies developing a novel, low-to-moderate risk medical device without a clear predicate, such as an AI-based diagnostic software, the De Novo pathway offers a route to market. A critical part ...

When planning a 510(k) submission, medical device manufacturers often focus on the official FDA user fee as a primary budgetary line item. However, this fee represents only a fraction of the total inv...

When planning a 510(k) submission, what are the key considerations regarding the Medical Device User Fee Amendments (MDUFA) fees, and how does a company determine whether it qualifies for the standard...

For a company developing a novel, low-to-moderate risk medical device, such as an AI-powered diagnostic software or a unique wearable biosensor, the De Novo pathway is often the appropriate route for ...

When planning for the commercialization of a new Class II medical device, sponsors often focus on the FDA's 510(k) review timeline. While the FDA has established performance goals for review, the tota...

When preparing a 510(k) submission, sponsors may face a significant challenge when their new device has the same intended use as a predicate but incorporates different fundamental materials or technol...

If you’re reading this, there’s a good chance you’re in one of these situations: You’ve built (or are building) a medical device or health software, Someone said the words “510(k) submission”, And no...

When a company develops a novel, low-to-moderate risk device, such as a unique wearable biosensor, and determines that no suitable predicate exists for a 510(k) submission, the De Novo Classification ...

When a manufacturer seeks to expand the indications for use (IFU) of an existing 510(k)-cleared device—for instance, by extending a diagnostic assay from an adult population to a pediatric one—how do ...

When preparing a 510(k) submission, selecting an appropriate predicate device is a foundational step for demonstrating substantial equivalence. However, sponsors often face a scenario where no single,...

For medical device companies, particularly startups and small businesses, managing the costs associated with regulatory submissions is a critical planning component. The FDA's Medical Device User Fee ...

When preparing a 510(k) submission, how can sponsors systematically develop a performance testing strategy that demonstrates substantial equivalence to a predicate device? The foundation of this stra...

When a new medical device combines features from multiple existing devices, how can sponsors effectively justify substantial equivalence in a 510(k) submission using a 'multiple predicate' or 'split p...

A 510(k) submission for a new Class II device, such as a novel orthopedic implant or diagnostic software, has successfully passed the FDA’s Refuse-to-Accept (RTA) screening. While the FDA’s goal is to...