Regulatory Q&A Forum

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...

After a medical device sponsor submits a comprehensive response to an FDA Additional Information (AI) request for a 510(k), what is the expected review timeline, and what factors influence the time un...

When a manufacturer plans to modify a 510(k)-cleared device, such as implementing a software update to an infusion pump that alters the user interface and alarm logic, what is the appropriate framewor...

Finding the right FDA 510(k) regulatory consultant can save you months of delays and tens of thousands of dollars in rework costs. However, the 510(k) consulting market can be overwhelming: some firms...

When planning a De Novo Classification Request for a novel medical device, such as an AI-powered diagnostic software or a unique wearable biosensor, sponsors must account for the mandatory Medical Dev...

After a medical device receives 510(k) clearance, manufacturers often implement changes to improve its design, update materials, or enhance the manufacturing process. A critical regulatory challenge a...

For a new medical device submitted through the Traditional 510(k) pathway, how can a sponsor determine whether non-clinical performance data alone is sufficient to demonstrate substantial equivalence,...