Regulatory Q&A Forum

For a Class II medical device with clear technological differences from its chosen predicate—such as an orthopedic implant with a novel biocompatible coating or an infusion pump with significant softw...

When developing a combination product, such as an antimicrobial-coated catheter or a pre-filled injector pen, how should a sponsor definitively determine the product's Primary Mode of Action (PMOA) to...

Beyond a surface-level check against the FDA's Refuse to Accept (RTA) checklist, what systematic, in-depth review process can a sponsor implement to proactively identify and resolve common administrat...

When a sponsor develops a novel medical device by creating a hybrid system—for example, an electrosurgical device that combines a unique energy waveform from Predicate A with an advanced tissue-monito...

For a company developing a digital health product, such as a wearable sensor that analyzes sleep data, what is a robust analytical framework for determining whether the product is a regulated medical ...

For manufacturers of network-connected medical devices, such as a Wi-Fi-enabled patient monitor, what are the essential components of a robust cybersecurity documentation package for a 510(k) submissi...

How can a manufacturer of a lower-risk device, such as a Class I handheld diagnostic instrument or a Class II software-based patient monitoring tool, strategically implement a "right-sized" Quality Ma...

When preparing a 510(k) submission, what are the critical process steps and documentation requirements a sponsor must manage to ensure the correct MDUFA user fee is paid, thereby avoiding a Refuse to ...

For a small medical device company planning its first 510(k) submission, what are the critical steps and strategic considerations for successfully qualifying for a reduced MDUFA user fee through the S...

With the mandatory transition to eSTAR for 510(k) submissions, sponsors of Class II devices, such as novel diagnostic imaging software or connected surgical instruments, are re-evaluating their go-to-...

When a medical device sponsor develops a product with novel technological characteristics but an intended use identical to legally marketed devices, what is the strategic framework for determining if ...

While the FDA's MDUFA performance goal for reviewing a 510(k) submission is 90 calendar days, the total time from submission to clearance often extends significantly longer. For sponsors planning a pr...

For a sponsor developing a 510(k) for a Class II implantable device, such as a PEEK spinal cage or a titanium bone screw with permanent tissue contact, what constitutes a robust, risk-based biocompati...

When a manufacturer modifies a previously cleared 510(k) device—for example, updating an infusion pump with a new motor and software incorporating enhanced cybersecurity features—while keeping the int...

For a small medical device company preparing a 510(k) submission, successfully qualifying for the reduced MDUFA user fee is a critical financial planning step. Beyond simply identifying the fee on the...

When preparing a 510(k) for a Class II medical device, particularly one with significant software or cybersecurity elements like a connected infusion pump or diagnostic SaMD, what are the most critica...

The FDA’s 90-day performance goal for 510(k) review is a widely cited metric, but it represents 'FDA Days,' not calendar days, a distinction that significantly impacts project timelines. For a Class I...

For a Class II device with patient-contacting components intended for a 510(k) submission, what constitutes a robust and defensible biocompatibility evaluation strategy that anticipates common FDA que...

When preparing a 510(k) for a device that has different technological characteristics from its predicate—such as a novel material, a different energy source, or a new software algorithm—how can sponso...

When a medical device manufacturer develops a new device that combines features from multiple legally marketed devices—for example, a new catheter incorporating an advanced sensor from Predicate A and...