Regulatory Q&A Forum

When a medical device manufacturer receives an FDA Form 483 with observations citing systemic deficiencies, such as an inadequate CAPA process or insufficient process validation, what are the key stra...

For a manufacturer of a Class I medical device, such as a manual surgical instrument or a basic health data application, that is exempt from 510(k) premarket notification, what constitutes a comprehen...

When preparing a 510(k) submission for a medical device that has technological differences compared to its predicate—such as a patient monitoring system with a novel sensor material or a significantly...

Beyond common administrative oversights like incorrect user fees or missing organizational forms, what are the critical, yet often overlooked, content-related deficiencies that cause a 510(k) submissi...

For a medical device sponsor navigating an FDA Additional Information (AI) request during a 510(k) review, what constitutes a best-practice framework for developing a response that is not only complet...

When preparing a 510(k) submission for a device that combines features from multiple legally marketed products—such as an orthopedic implant using a well-established core design from Predicate A but i...

For a manufacturer of a Class I medical device exempt from 510(k) premarket notification, what is a comprehensive and practical framework for implementing FDA’s General Controls? Moving beyond a simpl...

For manufacturers of Class I medical devices that are exempt from 510(k) premarket notification, such as non-sterile tongue depressors or elastic bandages, what are the specific, non-negotiable requir...

For a medical device company planning a 510(k) submission for a Class II device, such as a new surgical instrument, what is a comprehensive framework for budgeting beyond the standard FDA user fee, wh...

With the mandatory transition to the eSTAR format for 510(k) submissions, avoiding a Refuse-to-Accept (RTA) decision has become a critical first hurdle. While the template provides structure, it also ...

While the FDA’s goal for a traditional 510(k) review is 90 calendar days, this timeline represents "FDA Days" and can be paused. A common event that disrupts this clock is the issuance of an Additiona...

When a 510(k) submission is placed on hold due to an FDA Additional Information (AI) request, sponsors face a critical 180-day window to submit a complete response before the submission is considered ...

For manufacturers of Class I or 510(k)-exempt Class II devices, such as a basic wellness app or an elastic bandage, adhering to FDA's General Control labeling requirements under 21 CFR Part 801 is a f...

When a manufacturer of a 510(k)-cleared device, such as an infusion pump or a diagnostic software tool, discovers that its primary predicate device has been recalled for a significant safety or perfor...

Beyond obvious administrative omissions like missing user fee forms, what are the more nuanced reasons a 510(k) submission for a Class II device, such as a cardiovascular catheter, might receive a Ref...

When a medical device manufacturer is preparing a 510(k) submission for a modern device—for instance, a digital diagnostic tool using novel software algorithms—how can they systematically establish su...

For manufacturers of Class I medical devices exempt from premarket notification (510(k)), what is a comprehensive framework for ensuring full compliance with FDA's General Controls before and after pl...

For a small medical device company aiming to leverage the FDA's Small Business Determination (SBD) program to reduce MDUFA user fees, what are the critical operational and documentation considerations...

When developing a performance testing strategy for a new Class II device intended for a 510(k) submission, such as a diagnostic immunoassay or an electronic infusion pump, what is a systematic process...

When preparing a 510(k) submission, what are the most critical, yet often overlooked, documentation details that lead to a Refuse to Accept (RTA) hold, moving beyond simple omissions like missing form...