Regulatory Q&A Forum
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What is the average FDA 510k review time after an AI request?
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...
How to write a substantial equivalence argument for a 510k submission?
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,...
How much does a 510k submission cost including consultant and testing fees?
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...
What are the 2024 FDA user fee costs for a small business 510k submission?
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...
How long does the FDA 510k review process actually take?
Beyond acknowledging the FDA's 90-day review goal for a 510(k), how can a sponsor develop a more realistic internal timeline that accounts for the common "clock-stopping" events which determine the ac...
How long does the FDA 510k review clock stop during an Additional Information request?
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 does a modification to a cleared device require a new 510k?
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...
How to justify substantial equivalence with multiple predicate devices?
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...
How does an FDA Additional Information request affect the 90-day review clock?
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...
What cybersecurity documentation is required for a SaMD 510k submission?
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...
How does the FDA 90-day review clock for a 510k actually work?
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...
How much does a 510k submission cost with MDUFA fees?
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...
What is the total cost of a 510k submission including consultant fees?
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...
What should I do if my chosen predicate device is recalled?
When a medical device sponsor discovers that their chosen primary predicate for a 510(k) submission has been recalled, what is the comprehensive analytical framework they should use to determine a pat...
What are the requirements for using the Special 510k pathway?
For a manufacturer implementing a design modification to a legally marketed device, such as changing the surface coating on a Class II orthopedic screw system, what is a comprehensive framework for ri...
How to effectively search the FDA 510k database for predicate devices?
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...
What cybersecurity documentation does the FDA require for a 510k?
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 common reasons for a 510k Refuse to Accept (RTA) letter?
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...
How to write a strong substantial equivalence rationale for a 510k submission?
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? ...
What are the most common reasons for an FDA RTA hold on an eSTAR submission?
The FDA’s electronic Submission Template And Resource (eSTAR) is designed to standardize 510(k) submissions, theoretically reducing the risk of administrative errors that can lead to a Refuse to Accep...