Regulatory Q&A Forum

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...

When preparing a 510(k) submission for a device with several potential predicates, such as a new diagnostic catheter with a modified tip design, what comprehensive strategy should a sponsor employ to ...

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...

When utilizing a multiple predicate (or "split predicate") strategy in a 510(k) submission, where a new device combines key features from two or more different legally marketed devices, what is a comp...

After receiving an FDA Form 483, a medical device manufacturer faces a critical 15-business-day window to submit a formal response. How can a firm strategically structure this period to develop a comp...

For medical device sponsors, a common point of confusion is the discrepancy between the FDA's 90-day 510(k) review goal and the actual "total time to clearance." While the agency aims for 90 FDA Days,...

How can medical device sponsors develop a robust internal checklist to proactively mitigate the most common administrative and content-related deficiencies that lead to a Refuse to Accept (RTA) hold o...

When preparing a 510(k) submission for a device incorporating novel features, such as a diagnostic catheter with a new sensor technology, sponsors must often select a predicate from a pool of imperfec...

When preparing a 510(k) for a Class II device, such as a diagnostic ultrasound system, how does a sponsor systematically distinguish between, identify, and document conformance with both General and S...

Beyond creating a basic checklist of FDA’s General Controls, what practical, auditable framework can a medical device manufacturer implement to ensure robust, ongoing compliance? For instance: 1. Es...

Beyond simple administrative oversights like an improperly formatted eCopy or a missing user fee form, what are the most critical, yet frequently overlooked, technical and content-related deficiencies...

When preparing a 510(k) submission for a device with different technological characteristics (DTCs) compared to its predicate, what is a robust framework for establishing substantial equivalence (SE)?...

When a medical device manufacturer identifies a product classification regulation for their Class II device that states it is "exempt from the premarket notification procedures in subpart E of part 80...

I'm evaluating multiple EU Responsible Person providers and want to make sure I ask the right questions. What should I look for, what questions should I ask, and what are the red flags to avoid?