Regulatory Q&A Forum

When a sponsor's 510(k) submission for a device, such as a new orthopedic implant or diagnostic software, receives a 'Refuse to Accept' (RTA) decision, what is a systematic and robust process for craf...

When a new medical device combines distinct technological features from multiple legally marketed predicates—for instance, an imaging catheter incorporating the sensor technology from Predicate A and ...

For a developer of a Software as a Medical Device (SaMD) or wearable technology intended to qualify under the FDA's General Wellness Policy, what constitutes a robust and defensible internal justifica...

For a manufacturer preparing to market a new Class I or simple Class II device in the U.S., how can the broad requirement of "General Controls" be translated into a practical, audit-ready documentatio...

Given that the FDA's eSTAR template is now mandatory for 510(k) submissions, what are the most common eSTAR-specific pitfalls that lead to a Refuse to Accept (RTA) decision, particularly for a Class I...

When developing a 510(k) submission for a device with technological differences from its predicate—such as an infusion pump incorporating updated software and a new user interface—how can sponsors con...

When pursuing a 510(k) using a 'split predicate' strategy, such as for an orthopedic screw combining a novel thread design from one predicate with a unique biocompatible coating from another, what is ...

For sponsors of Class I or low-risk Class II devices, navigating the FDA's General Controls for labeling can present subtle but significant compliance risks. Beyond simply listing the device name, wha...

For a small medical device company or startup, successfully navigating the Medical Device User Fee Amendments (MDUFA) Small Business Determination (SBD) process is often a critical financial step befo...

When a sponsor receives an Additional Information (AI) request for a 510(k) submission, such as for a Class II diagnostic imaging software, what is a comprehensive framework for developing a strategic...

When preparing a 510(k) for a 'cyber device,' such as a Software as a Medical Device (SaMD) or a network-connected monitor, how can sponsors construct a cybersecurity documentation package that provid...

After a sponsor submits a comprehensive response to an FDA Additional Information (AI) request for a 510(k), the review clock restarts. While this is a standard part of the process, it creates signifi...

When a medical device sponsor develops a novel product by combining key features from two or more legally marketed devices—such as integrating a specific sensor technology from one cleared device with...

When preparing a 510(k) for a modern device, such as a digital patient monitoring system, how can a sponsor establish substantial equivalence to a predicate cleared decades ago that lacks data for cur...

When preparing a 510(k) for a device with technological differences from its predicate, such as an orthopedic implant with a novel surface coating, how can a sponsor build a scientifically robust and ...

For a small medical device company aiming to qualify for the FDA’s Small Business Determination (SBD) program to reduce premarket submission user fees, what are the critical steps and common pitfalls ...

For manufacturers of novel food ingredients, such as a new plant-based protein or a fermentation-derived flavoring agent, what are the comprehensive steps and best practices for establishing a defensi...

While Medical Device User Fee Amendments (MDUFA) performance goals establish a target for the number of 'FDA days' to review a 510(k) submission, regulatory project managers must plan for a 'Total Tim...

For medical device companies, particularly startups, how is eligibility for the MDUFA small business discount on a 510(k) user fee determined, and what are the key procedural steps and common pitfalls...

While the FDA’s performance goal for a 510(k) review is 90 calendar days, this target often creates confusion as it only reflects the time the submission is actively under FDA review. The total time f...