Regulatory Q&A Forum
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As non-EU manufacturers prepare for the EU’s Packaging and Packaging Waste Regulation (PPWR), a common question arises regarding budgeting for compliance. However, simply asking about the cost of an E...
With the Modernization of Cosmetics Regulation Act (MoCRA) mandating that foreign cosmetic establishments designate a U.S. Agent, what practical framework can a company use to select a qualified and e...
As medical device manufacturers plan for compliance through 2026, selecting an external 'Person Responsible for Regulatory Compliance (PRRC) as a Service' is a critical strategic decision under the EU...
As medical devices become increasingly interconnected, robust cybersecurity is a critical component of ensuring device safety and effectiveness. FDA’s expectations for cybersecurity documentation in p...
With the introduction of the EU's Packaging and Packaging Waste Regulation (PPWR), non-EU manufacturers face new compliance obligations that extend beyond traditional medical device or IVD requirement...
Under the Modernization of Cosmetics Regulation Act (MoCRA), foreign cosmetic facilities are required to designate a U.S. Agent to serve as their domestic point of contact for the FDA. While specific ...
As the interpretation of EU MDR requirements evolves, how can medical device manufacturers effectively structure and manage a "Person Responsible for Regulatory Compliance (PRRC) as a Service" relatio...
With the 2026 REACH registration deadline for lower-tonnage substances approaching, non-EU companies face the critical task of appointing an Only Representative (OR). Beyond simply confirming an EU le...
How should manufacturers of a connected Class II device, such as an integrated continuous glucose monitoring (iCGM) system regulated under 21 CFR 862.1355, approach the documentation of a Secure Produ...
Given that the Modernization of Cosmetics Regulation Act (MoCRA) mandates that foreign cosmetic product facilities designate a United States Agent, what are the key operational and strategic considera...
When planning budgets for 2026, how should a medical device manufacturer evaluate the total cost of engaging a 'PRRC as a Service' provider under the EU MDR? Beyond a simple annual fee, what specific ...
When developing a novel Class II multiplex in vitro diagnostic (IVD) test system, such as a pharmacogenetic assessment system, how should a manufacturer navigate the interplay between general 510(k) r...
For sponsors developing sophisticated in-vitro diagnostic (IVD) devices, such as a "drug metabolizing enzyme genotyping system" (regulated under 21 CFR 862.3360) or a "pharmacogenetic assessment syste...
With the increased responsibilities and liabilities placed on EU Authorized Representatives (AR) under the Medical Device Regulation (MDR), how should a non-EU medical device manufacturer conduct due ...
When a medical device manufacturer, particularly a small or medium-sized enterprise without in-house regulatory capacity, evaluates an external 'Person Responsible for Regulatory Compliance (PRRC) as ...
When a medical device manufacturer, especially a non-EU entity or a small enterprise, selects an external 'Person Responsible for Regulatory Compliance (PRRC) as a Service,' how can they develop a com...
When a manufacturer develops a new in vitro diagnostic (IVD) device, such as a test intended for newborn screening or to detect an infectious agent, establishing its performance characteristics is a c...
For sponsors developing connected medical devices, such as an integrated continuous glucose monitoring system (iCGM) regulated under 21 CFR 862.1355, how should the principles from FDA's guidance, "Cy...
With significant updates to the EU's Waste from Electrical and Electronic Equipment (WEEE) Directive and Extended Producer Responsibility (EPR) frameworks anticipated around 2026, how should producers...
With major updates to the ISO 10993-1 standard and associated FDA guidance anticipated around 2026, how should medical device manufacturers proactively evolve their biological evaluation strategies to...