Regulatory Q&A Forum
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For a sponsor developing a novel Class II in vitro diagnostic (IVD) device, what is the most effective way to integrate FDA's Special Controls into the product development lifecycle and 510(k) submiss...
How should sponsors of connected medical devices effectively integrate cybersecurity management into their existing Quality Management System (QMS) to align with FDA's expectations for total product l...
With the Modernization of Cosmetics Regulation Act (MoCRA) mandating that foreign cosmetic facilities designate a U.S. Agent, many companies are evaluating the associated costs. However, focusing sole...
Given the requirement under the Modernization of Cosmetics Regulation Act (MoCRA) for foreign cosmetic facilities to designate a U.S. Agent, what key criteria should be used to evaluate and select the...
When medical device manufacturers, particularly small and medium-sized enterprises, plan their budgets for 2025, a key consideration is the cost of engaging a "Person Responsible for Regulatory Compli...
Under the EU Medical Device Regulation (MDR), manufacturers must appoint a Person Responsible for Regulatory Compliance (PRRC). For many small and medium-sized enterprises (SMEs), outsourcing this fun...
With European authorities advancing a universal restriction proposal for per- and polyfluoroalkyl substances (PFAS) under REACH, how can a non-EU manufacturer move beyond standard evaluation criteria ...
With ECHA's 2026 enforcement project (REF-14) and its associated pilot project specifically targeting Only Representatives (ORs), how should non-EU manufacturers critically evaluate and select a REACH...
When developing a Class II in vitro diagnostic (IVD) device, how do FDA's regulations in 21 CFR and associated Class II Special Controls Guidance Documents work together to establish the specific requ...
When preparing a premarket submission for a connected medical device, such as a Class II Software as a Medical Device (SaMD) or a network-enabled diagnostic instrument, how should sponsors effectively...
With upcoming WEEE and EPR compliance deadlines, particularly new requirements taking effect by 2026, medical device manufacturers face a critical strategic decision: how to select a compliance partne...
With significant environmental compliance deadlines approaching in 2026, manufacturers of medical devices, particularly those incorporating electronics, face increasing pressure to comply with Waste E...
When budgeting for EU MDR compliance, particularly for 2026 and beyond, many medical device manufacturers consider outsourcing the Person Responsible for Regulatory Compliance (PRRC) role. While speci...
As medical device manufacturers plan their compliance strategies for 2026 and beyond under the EU MDR, how should they strategically evaluate and select a 'PRRC as a Service' provider to ensure both r...
When a non-EU manufacturer of a medical device, such as a Class II IVD like an acute kidney injury test system (governed by regulations like 21 CFR 862.1220), needs to comply with broad European chemi...
With the European Chemicals Agency (ECHA) expected to release a draft opinion on its comprehensive PFAS restriction proposal, non-EEA manufacturers are increasingly focused on ensuring compliance with...
For a novel Software as a Medical Device (SaMD) intended as a retinal diagnostic software device, what are the key regulatory considerations when building a submission strategy around the pathway defi...
What is the role of Class II Special Controls in the premarket notification (510(k)) process for in vitro diagnostic (IVD) devices, and how should sponsors proactively address them? For many moderate...
As global Waste Electrical and Electronic Equipment (WEEE) and Extended Producer Responsibility (EPR) regulations evolve, with significant new compliance deadlines anticipated around 2026, how should ...
As the 2026 deadlines for various Extended Producer Responsibility (EPR) and Waste Electrical and Electronic Equipment (WEEE) schemes approach, how should medical device manufacturers structure their ...