Regulatory Q&A Forum

For a sponsor developing a novel medical device, such as a Class II diagnostic Software as a Medical Device (SaMD), what are the best practices for structuring a Pre-Submission (Q-Sub) package to elic...

For a medical device startup planning a submission in fiscal year 2025 (which begins October 1, 2024), what are the critical strategic considerations and procedural steps for successfully obtaining Sm...

Beyond ensuring basic administrative requirements like correct eCopy formatting are met, what specific, high-risk documentation areas should sponsors meticulously review to prevent a 510(k) Refuse to ...

When preparing a 510(k) submission for a Class II device, such as an orthopedic implant or a device with software, what are the most common yet avoidable deficiencies that lead to a Refuse to Accept (...

How can a medical device sponsor develop a robust strategy to navigate the FDA's 510(k) Refuse to Accept (RTA) policy, moving beyond a simple checklist review to proactively prevent common administrat...

When a manufacturer of a 510(k)-cleared, Class II Software as a Medical Device (SaMD) plans a new software release, the decision between submitting a new 510(k) and documenting the changes via a Lette...

For a manufacturer of a low-risk medical device determined to be 510(k)-exempt, such as a manual surgical instrument or certain types of clinical decision support software, what are the comprehensive,...

A Refuse to Accept (RTA) decision from the FDA can significantly delay the 510(k) review process, often stemming from administrative or content-related omissions rather than fundamental scientific fla...

When preparing a 510(k), how can a sponsor craft a compelling substantial equivalence (SE) argument that thoroughly justifies the device's equivalence to a chosen predicate, particularly when there ar...

When preparing a 510(k) for a new device that introduces different technological characteristics compared to its predicate—such as a diagnostic tool using a novel software algorithm—what is a systemat...

For a resource-constrained small business planning its first 510(k) submission, how can a comprehensive and realistic budget be developed that accounts for the full spectrum of costs beyond the base F...

When a new medical device combines technological features from multiple legally marketed devices, how can a sponsor construct a robust 510(k) submission that effectively justifies substantial equivale...

For a small medical device company preparing its first 510(k), qualifying for the FDA's Small Business Determination (SBD) program is a critical step to manage submission costs. While the user fee red...

I'm ready to engage a Cosmetics Responsible Person provider but want to make sure I'm comparing providers effectively. What should I evaluate when comparing EU Cosmetics RP providers, and what questio...

I have an EU importer or distributor handling my cosmetic products in the EU. Do I still need a separate EU Cosmetics Responsible Person, or can the importer/distributor fulfill this role?

I'm considering switching Responsible Persons due to service issues or cost. Can I change my EU Cosmetics Responsible Person, and what's the process? What are the implications for products already on ...

I need to update my cosmetic product labeling for the EU market. What are the specific requirements for indicating the Responsible Person on labels and packaging under EU Cosmetics Regulation?

I understand that serious undesirable effects must be reported under EU Cosmetics Regulation, but I'm unclear on the reporting requirements and the Responsible Person's role in SUE reporting. Can you ...

EU Cosmetics Regulation requires a written mandate between the manufacturer and Responsible Person. What are the essential elements that must be included to ensure compliance and operational effective...

I understand the Responsible Person must maintain a Product Information File (PIF), but I'm unclear on what exactly must be in the PIF, who creates it, and what the Responsible Person's obligations ar...