Regulatory Q&A Forum

For a company developing a novel, low-to-moderate risk device, the FDA De Novo pathway is often the appropriate regulatory route when no predicate device exists. While the Medical Device User Fee Amen...

The FDA's Refuse to Accept (RTA) policy for 510(k) submissions acts as a critical administrative checkpoint to ensure a file is complete before the 90-day substantive review clock starts. An RTA hold ...

When is a "split predicate" strategy appropriate for a 510(k) submission, and how can sponsors effectively justify using multiple predicate devices to the FDA? This situation typically arises when a ...

For sponsors of novel low-to-moderate risk medical devices, such as an AI-powered diagnostic software or a unique wearable biosensor, the De Novo pathway offers a route to market. The FDA has a MDUFA ...

For a network-connected medical device, such as a remote patient monitoring system or smart infusion pump, what are the fundamental types of cybersecurity documentation the FDA generally expects in a ...

In a traditional 510(k) submission, a sponsor typically identifies a single primary predicate device to which it claims substantial equivalence. However, modern medical devices often integrate technol...

After a medical device sponsor submits a 510(k) premarket notification for a product, such as a novel orthopedic implant or a Class II Software as a Medical Device (SaMD), the submission first undergo...

What are the key regulatory and strategic considerations for a 510(k) sponsor when their chosen primary predicate device is subject to a recall? This scenario presents a significant challenge. For ex...

During the initial 15-day review of a 510(k) submission, FDA conducts an administrative check based on its Refuse to Accept (RTA) policy to ensure the dossier is sufficiently complete for a substantiv...

While the FDA has a performance goal of making a decision on a De Novo classification request within 150 review days, sponsors of novel devices often find the total calendar time from submission to fi...

When preparing a 510(k) submission, manufacturers often face a challenge when the most suitable predicate device was cleared decades ago. These "legacy" predicates may have been approved before the ad...

What are some of the most common administrative and content-related deficiencies that can lead to a Refuse to Accept (RTA) decision for a 510(k) submission? An RTA decision is issued when the FDA det...

When a medical device sponsor receives a Not Substantially Equivalent (NSE) determination for a 510(k) submission, particularly for a novel device such as an AI-powered diagnostic tool, the De Novo cl...

Manufacturers of 510(k)-cleared medical devices often face the challenge of determining the appropriate regulatory path for post-market modifications. For instance, consider a company that plans to up...

When a medical device sponsor seeks 510(k) clearance for a new device that has the same intended use as a predicate device but incorporates different technological characteristics, how can they effect...

While the FDA's performance goal for reviewing a 510(k) submission is widely cited as 90 days, what factors contribute to the 'total elapsed time' from submission to a final decision often being longe...

What are the most common administrative reasons for an FDA 510(k) submission to receive a 'Refuse to Accept' (RTA) decision, and what proactive steps can sponsors take to ensure their submission packa...

When a medical device sponsor identifies the most suitable predicate for their 510(k) submission, but that predicate was cleared decades ago, how can they effectively demonstrate substantial equivalen...

I am working on preparing a 510(k) submission and want to understand how AI can help automate the creation and management of compliance checklists. What are the best practices, key capabilities, and i...

When a medical device sponsor receives a multi-point Additional Information (AI) request from the FDA during a 510(k) review, it initiates a critical phase governed by a 180-day response deadline. How...