Regulatory Q&A Forum

For a small medical device company or startup, managing cash flow is critical. The Medical Device User Fee Amendments (MDUFA) user fees required for premarket submissions like a 510(k) can represent a...

Medical device sponsors preparing a 510(k) submission must account for the Medical Device User Fee Amendments (MDUFA) user fee, which is required before the FDA will accept the submission for review. ...

When a sponsor develops a novel, low-to-moderate risk medical device, such as an AI-powered diagnostic tool, they often face a critical strategic decision if no clear predicate device exists. The two ...

In the context of the 510(k) program, how should a manufacturer approach a 'split predicate' strategy when no single device can serve as a primary predicate? This situation often arises for devices th...

When preparing a 510(k) submission, a sponsor often identifies multiple potential predicate devices, each with its own advantages and disadvantages. Consider a scenario involving a new Class II diagno...

For small medical device companies and startups, budgeting for a 510(k) submission involves more than just development and testing costs; FDA user fees under the Medical Device User Fee Amendments (MD...

When a manufacturer plans to modify a 510(k)-cleared medical device—for example, by changing a component supplier for an infusion pump or updating the software algorithm in a diagnostic imaging system...

For a sponsor developing a connected Software as a Medical Device (SaMD), such as an AI-powered diagnostic tool, what are the key elements of a comprehensive cybersecurity documentation package for a ...

For a new Class II medical device seeking clearance via the 510(k) pathway, a critical strategic decision involves defining the scope of performance testing required to demonstrate substantial equival...

When a manufacturer of a 510(k)-cleared device, such as a cardiovascular catheter, plans to implement post-market changes, a critical regulatory assessment is required. These modifications can range f...

When preparing a 510(k) submission, the choice of a predicate device is a foundational strategic decision. Sponsors may face a scenario where no single legally marketed device is a perfect match. For ...

Our team is preparing a 510(k) submission for a new patient monitoring device, and we’ve just learned that our chosen primary predicate has been subject to a Class II recall due to a specific design f...