Regulatory Q&A Forum
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How to choose between a 510k and De Novo pathway for my device?
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 ...
How do I justify substantial equivalence with multiple predicate devices?
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...
How to choose the best predicate device for a new medical device?
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...
What is the 2024 FDA user fee for a 510k small business application?
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 is a new 510k required for a cleared device modification?
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...
What are the cybersecurity documentation requirements for a SaMD 510k submission?
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 ...
What level of performance testing is needed to claim substantial equivalence?
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...
How to determine if a device modification requires a new 510k?
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...
How do I choose the best predicate device for my 510k submission?
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 ...
What happens to my 510k submission if the predicate is recalled?
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...