Regulatory Q&A Forum
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For a startup launching a Class I medical device, such as an elastic bandage or tongue depressor, navigating the "General Controls" can be complex due to common misconceptions about exemptions. While ...
How do I prove substantial equivalence with limited predicate device data?
When preparing a 510(k) for a medical device, such as a Class II Software as a Medical Device (SaMD) for diagnostic imaging analysis, a sponsor may identify a suitable predicate device that has very l...
What testing data is required for substantial equivalence in a 510k?
When developing a performance testing strategy to demonstrate substantial equivalence for a 510(k), how should a sponsor systematically translate the differences between their new device and a chosen ...
How do I prove substantial equivalence to a predicate device?
When preparing a 510(k) for an innovative Software as a Medical Device (SaMD) that utilizes an advanced technology like an AI/ML algorithm, a significant challenge arises if the most suitable predicat...
For medical device companies preparing for the upcoming fiscal year, how should they navigate the annual FDA establishment registration process to ensure uninterrupted U.S. market access? This mandato...
For medical device manufacturers transitioning from a quality system based on the former 21 CFR Part 820 to the new Quality Management System Regulation (QMSR), which incorporates ISO 13485:2016 by re...
When a medical device firm receives an FDA Form 483, the 15-business-day response timeframe is widely considered a critical deadline for preventing the observations from escalating to a Warning Letter...
How do I respond to an FDA Additional Information (AI) request?
When a sponsor of a Class II medical device, such as a software as a medical device (SaMD), receives an Additional Information (AI) request for their 510(k) submission, what are the key strategic step...
What should I do if my 510k predicate device has been recalled?
When a medical device manufacturer discovers that a primary predicate device cited in their cleared 510(k) submission has been subjected to a significant recall, particularly a Class I recall for a de...
How to prove substantial equivalence with multiple predicate devices?
When developing a 510(k) submission for a new device that combines features from multiple legally marketed devices—for instance, a novel guidewire that uses the core construction and intended use of P...
How do I justify using multiple predicate devices in a 510k submission?
When a new medical device integrates features from multiple sources, such as a patient monitor using the core physiological sensing technology of one predicate and the novel software and cybersecurity...
Beyond the basic definitions, how does the fundamental difference between FDA 'clearance' (via 510(k)) and 'approval' (via PMA) translate into distinct strategic and operational plans for a medical de...
What happens if my chosen 510k predicate device gets recalled?
When a medical device manufacturer discovers that their chosen predicate for a 510(k) submission has been recalled, what is the strategic framework for determining if the predicate can still be used t...
What to do if my 510k submission receives an RTA letter?
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...
How to determine substantial equivalence with multiple predicate devices?
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 ...
How to choose the best predicate device for a 510k submission?
When a manufacturer identifies multiple potential predicate devices for a 510(k) submission, what is a robust framework for selecting the optimal candidate, especially when no single predicate is a pe...
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...
What should I do if my 510k predicate device gets recalled by the FDA?
For a manufacturer of a 510(k)-cleared Class II device, what is a comprehensive, step-by-step framework for responding when their primary predicate device is recalled due to a significant safety or pe...
What are common mistakes to avoid when using the FDA's eSTAR 510k template?
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...