Regulatory Q&A Forum

When a medical device sponsor submits a 510(k) for a product, such as a new diagnostic imaging software, receiving a Refuse-to-Accept (RTA) hold can cause significant project delays. Unlike an Additio...

For a manufacturer with a 510(k)-cleared medical device, such as a diagnostic imaging workstation, what is a comprehensive and defensible methodology for determining if a planned software update requi...

For regulatory affairs professionals budgeting for a 510(k) submission, what are the key strategic and operational considerations for navigating the MDUFA user fee requirements for the current fiscal ...

For a manufacturer with a 510(k)-cleared device, such as an electrosurgical unit, what is a robust and defensible framework for determining if a proposed modification requires a new 510(k) submission ...

After a sponsor submits a comprehensive response to an FDA Additional Information (AI) request for a 510(k), the review clock officially restarts, but forecasting the time until a final clearance deci...

When preparing a 510(k) for a device that introduces a novel feature to an established design, such as a Class II orthopedic bone screw with a new surface coating intended to improve osseointegration,...

When planning for a 510(k) submission, how can a medical device sponsor develop a comprehensive budget that goes beyond the predictable FDA user fee to accurately forecast the major, variable costs as...

For a small medical device company preparing its first 510(k), successfully qualifying for the reduced small business user fee is a critical financial step. Beyond simply meeting the gross receipts or...

When a medical device sponsor's 510(k) submission is placed 'on hold' following an Additional Information (AI) request from the FDA, what are the detailed operational mechanics and strategic best prac...

When a manufacturer modifies a 510(k)-cleared device—for instance, implementing a software patch for an infusion pump to enhance cybersecurity, or changing a material in a single-use catheter due to a...

When a medical device sponsor develops a device by combining key features from multiple legally marketed predicates—for instance, an orthopedic implant using a porous coating from Predicate A and a lo...

When a sponsor submits a 510(k) for a Class II medical device, such as a novel patient monitoring system or diagnostic software, project timelines are often anchored to the FDA's 90-day review goal. H...

For a connected Software as a Medical Device (SaMD) undergoing 510(k) review, what defines a comprehensive cybersecurity documentation package that sufficiently demonstrates a "secure by design" appro...

While the FDA’s goal for a 510(k) review is 90 calendar days, this timeline represents "FDA Days" and often differs significantly from the total time to clearance. For sponsors of devices like a Class...

When planning a 510(k) submission for a new medical device, such as a Class II AI-powered diagnostic software, accurately forecasting costs is a critical step for financial planning and securing inves...

When calculating the total cost of a 510(k) submission, how can sponsors develop a comprehensive budget that accurately forecasts expenses beyond the standard FDA user fee? For a Class II device, such...

Beyond basic keyword searches, what advanced, multi-step strategies can medical device sponsors employ to effectively navigate the FDA 510(k) database and identify an optimal predicate device? For a n...

For a 'cyber device'—such as a cloud-connected patient monitor or smart infusion pump—what are the fundamental cybersecurity documentation components that the FDA expects to see within a 510(k) premar...

What are the most common administrative and content-related omissions that can lead to a 510(k) submission receiving a Refuse to Accept (RTA) letter from the FDA? The RTA policy is designed to act as...

When preparing a 510(k) submission for a new medical device that has technological differences compared to its predicate, what are the key elements of a robust Substantial Equivalence (SE) rationale? ...