Regulatory Q&A Forum
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When a non-EU manufacturer seeks to place a medical device on the European market, they must appoint an EU Authorized Representative (AR). While the fee structures for AR services can vary significant...
What key factors and due diligence steps should a non-EU medical device manufacturer implement when selecting an EU Authorized Representative (AR) under the Medical Device Regulation (EU) 2017/745? Be...
As foreign medical device establishments prepare for the FDA's Quality Management System Regulation (QMSR) to take effect on February 2, 2026, what constitutes a comprehensive strategy for selecting o...
For foreign medical device manufacturers preparing for the FDA's Quality Management System Regulation (QMSR) effective date of February 2, 2026, how should the selection of an FDA U.S. Agent be approa...
When evaluating external "Person Responsible for Regulatory Compliance (PRRC) as a Service" providers under the EU Medical Device Regulation (MDR), how can a startup or small manufacturer move beyond ...
When planning for 2026, how can a medical device manufacturer accurately forecast the cost of engaging an external 'Person Responsible for Regulatory Compliance' (PRRC) as a Service under the EU MDR, ...
For a non-EU manufacturer of a connected medical device, such as a Software as a Medical Device (SaMD) that processes personal health data from users in the European Union, navigating compliance can b...
When a non-EU company plans its compliance budget for 2026, what key factors should be considered to accurately estimate the cost of appointing a GDPR Article 27 Representative? While it is not possi...
While the introduction of broad EU regulations, such as the EU Deforestation Regulation (EUDR), highlights the need for a formal in-region presence for non-EU businesses, medical device manufacturers ...
For non-EU medical device manufacturers, appointing an EU Authorized Representative (AR) is a mandatory step for placing products on the European market under regulations like the MDR. While a common ...
With recent modernizations to the FDA's quality management system regulations for medical devices, how does the role and responsibility of a designated U.S. Agent evolve? Foreign establishments are re...
Given that FDA regulations require foreign medical device establishments to designate a U.S. Agent, how should manufacturers strategically select or re-evaluate their agent in light of the mandatory t...
When planning for future regulatory compliance under the EU MDR, particularly for 2026 and beyond, how can manufacturers effectively evaluate and budget for a "Person Responsible for Regulatory Compli...
With the European Chemicals Agency (ECHA) advancing its universal PFAS restriction proposal, non-EU manufacturers of substances, mixtures, and articles containing per- and polyfluoroalkyl substances f...
With the FDA's transition from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR) becoming effective on February 2, 2026, how should foreign medical device manu...
What biocompatibility testing is required for a 510k under ISO 10993?
For a medical device requiring patient contact, such as a new surgical instrument or catheter, how does a sponsor develop a robust and defensible biocompatibility evaluation plan for a 510(k) submissi...
When a medical device manufacturer receives an FDA Form 483 with observations pointing to systemic quality system deficiencies, such as inadequate CAPA procedures or gaps in design control documentati...
How to determine substantial equivalence if my device has new technology?
When a manufacturer develops a device with the same intended use as a predicate but incorporates novel technological characteristics—such as an AI-based diagnostic algorithm or a new composite materia...
What is the real 510k review time including FDA holds?
While the FDA's performance goal for a 510(k) review is often cited as 90 FDA Days, experienced regulatory professionals understand that the total calendar time from submission to clearance is typical...
How do I respond to an FDA RTA hold on my 510k submission?
When a 510(k) submission for a Class II device, such as a novel patient monitor or orthopedic implant, receives a Refuse to Accept (RTA) hold, the 90-day review clock is paused, creating significant p...