Regulatory Q&A Forum

For a novel Class II in vitro diagnostic (IVD) test system, such as a prognostic test for liver disease assessment (governed by regulations like 21 CFR 862.1622) or an acute kidney injury test system ...

With the implementation of the Modernization of Cosmetics Regulation Act (MoCRA), foreign cosmetic facilities are now required to designate a U.S. Agent to serve as their official point of contact wit...

With the implementation of the Modernization of Cosmetics Regulation Act (MoCRA), foreign cosmetic facilities must now designate a U.S. Agent for FDA communications. While this is a mandatory requirem...

When budgeting for 2026, how can medical device manufacturers accurately forecast the cost of engaging an external "PRRC as a Service" provider under the EU Medical Device Regulation (MDR)? Beyond a s...

While it is not possible to provide specific pricing for PRRC (Person Responsible for Regulatory Compliance) as a Service for 2026, manufacturers can anticipate costs by understanding the key factors ...

When developing a connected medical device, such as a Class II integrated continuous glucose monitoring (iCGM) system intended for submission in the 2025-2026 timeframe, what key regulatory considerat...

For non-EU manufacturers planning for market access in 2026, how can a comprehensive and realistic budget for an EU REACH Only Representative (OR) be developed that moves beyond simple service fees an...

For manufacturers of in vitro diagnostic (IVD) components, what are the key regulatory distinctions between marketing Analyte Specific Reagents (ASRs) and general-purpose laboratory equipment versus p...

For Class II medical devices, particularly in the diagnostics space, how do Special Controls function as a regulatory requirement beyond the baseline General Controls? While General Controls apply to ...

For a medical device manufacturer placing electronic devices on the market in the EU or other regions with Extended Producer Responsibility (EPR) regulations, how can they develop a robust framework f...

For developers of novel in vitro diagnostic (IVD) platforms, particularly in areas like pharmacogenetics or clinical chemistry, what are the critical regulatory delineators and evidence expectations t...

When planning for regulatory compliance budgets for 2026, many medical device manufacturers, particularly small to medium-sized enterprises, must account for the cost of outsourcing key roles. For com...

For medical device manufacturers preparing their long-term compliance strategy under the EU MDR, selecting an external Person Responsible for Regulatory Compliance (PRRC) is a critical decision. Beyon...

While specific costs for an outsourced Person Responsible for Regulatory Compliance (PRRC) service vary, manufacturers can evaluate potential expenses by understanding the key factors that influence p...

For medical device manufacturers, navigating the global regulatory landscape is becoming increasingly complex, extending beyond traditional premarket submission pathways like the FDA 510(k) or EU MDR....

While the annual cost for a REACH Only Representative (OR) service is a critical budgeting item for non-EU manufacturers, there is no standard, flat fee. The pricing structure is highly variable and d...

With the European Chemicals Agency (ECHA) continuing its evaluation of per- and polyfluoroalkyl substances (PFAS) under REACH, and with significant draft opinions anticipated around 2026, non-EU manuf...

For a Class II in vitro diagnostic (IVD) device, what is the role of Special Controls, and how do they differ from the General Controls that apply to all medical devices? General Controls are the bas...

For a novel Class II in vitro diagnostic (IVD) device, such as a pharmacogenetic assessment system or a mass spectrometry test system, what is the strategic role of FDA-recognized Special Controls in ...

When a medical device manufacturer based outside the European Union plans to enter the EU market, they face numerous compliance requirements. Two critical but often confused roles are the EU Authorize...