Regulatory Q&A Forum

I need to prepare for CPNP notification but want to understand what information I'll need to provide. What product details, documentation, and data must be included in the EU notification?

I understand CPNP is a centralized system, but I'm unclear if I still need to submit separate notifications to individual EU member states. Does CPNP cover all EU countries, or are there additional na...

I keep hearing about CPNP notifications. What is CPNP, is it mandatory, when do I need to notify, and what information must be submitted?

I'm confused about the Cosmetic Product Safety Report (CPSR). What is it, who creates it, who signs it, and what's the relationship between the CPSR and the Responsible Person?

I understand I need a Product Information File, but I'm unclear on retention requirements. How long must the PIF be maintained, where must it be stored, and what are the accessibility requirements?

I keep hearing about the Product Information File (PIF) requirement. What exactly is a PIF, what must be included in it, and why is it so important for EU cosmetics compliance?

I understand I need an EU Responsible Person, but I want to know exactly what they're responsible for. What are their day-to-day obligations and what happens if something goes wrong?

I'm a non-EU cosmetics brand selling directly to EU customers through my website. Do I still need an EU Responsible Person, or does this requirement only apply to physical retailers?

I'm trying to understand who is eligible to serve as the Responsible Person for my cosmetic products in the EU. Does it depend on where my products are manufactured, and what are the different scenari...

I'm new to EU cosmetics regulations and keep hearing about the "Responsible Person" requirement. Can you explain what an EU Cosmetics Responsible Person is in simple terms and why it's required?

For sponsors developing a novel medical device, such as an AI-powered diagnostic tool with no clear predicate, the FDA's Q-Submission (Q-Sub) program is a critical mechanism for obtaining early agency...

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 ...

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...

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 ...

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...

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...

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...