Regulatory Q&A Forum
Ask questions, share knowledge, and get help from the regulatory community
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...
With new Extended Producer Responsibility (EPR) laws set to take effect in several U.S. states by 2026, what comprehensive framework can a manufacturer use to evaluate and select the most suitable Pro...
With a growing patchwork of state-level Extended Producer Responsibility (EPR) regulations for electronics and other products set to take effect by 2026, how should a manufacturer structure its due di...
When manufacturers of complex Class II medical devices, particularly those incorporating software or novel diagnostic technologies, need to define their regulatory project scope, what is the systemati...
As medical device standards evolve, particularly with anticipated updates to global biocompatibility standards like the ISO 10993 series, how can manufacturers effectively budget for biocompatibility ...
As key international consensus standards for the biological evaluation of medical devices are updated, how should manufacturers strategically adapt their biocompatibility programs, not just for new su...
When planning a premarket submission to the FDA, how should a medical device sponsor move beyond a simple checklist mentality to develop a comprehensive and defensible biocompatibility evaluation stra...
With the European Chemicals Agency (ECHA) planning enforcement inspections in 2026 focused on Only Representatives (OR), how can a non-EU manufacturer, such as a medical device company whose products ...
For a novel Class II in vitro diagnostic (IVD) test system—for instance, a prognostic test for liver disease progression regulated under 21 CFR 862.1622 or an acute kidney injury test under 21 CFR 862...
With new Extended Producer Responsibility (EPR) laws for electronics and batteries set to take effect in several US states by 2026, manufacturers of medical devices that fall under these regulations f...
When developing a Class II in vitro diagnostic (IVD) device, how do sponsors determine the applicable "Special Controls," and what role do these controls play in a premarket submission beyond the stan...
As new state-level Extended Producer Responsibility (EPR) laws for electronics are introduced across the United States, medical device manufacturers must prepare for evolving compliance obligations. F...
With significant updates to Waste Electrical and Electronic Equipment (WEEE) and Extended Producer Responsibility (EPR) frameworks expected to take effect by 2026 in key markets like the EU, UK, and N...
With significant updates to the ISO 10993-1 standard anticipated for 2025/2026, how should medical device manufacturers strategically adapt their biocompatibility programs to ensure continued complian...
With the medical device industry anticipating a significant update to the ISO 10993-1 standard for biological evaluation, how should manufacturers strategically revise their approach to demonstrating ...
For medical device manufacturers based outside of Great Britain, appointing a UK Responsible Person (UKRP) is a critical step for market access. As the UK's regulatory framework continues to evolve to...