Regulatory Q&A Forum
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For foreign medical device establishments, the U.S. Agent serves as a critical link to the FDA, but their responsibilities extend far beyond initial registration. As regulatory expectations evolve, ho...
While the core legal responsibilities of an FDA U.S. Agent—serving as a communication link between the FDA and a foreign manufacturer—are not directly altered by the new Quality Management System Regu...
For medical device manufacturers preparing for updated Post-Market Surveillance and Vigilance (PMSV) reporting requirements, selecting an external Person Responsible for Regulatory Compliance (PRRC) s...
Given the EU MDR's mandate for a Person Responsible for Regulatory Compliance (PRRC) under Article 15, and with updated Post-Market Surveillance and Vigilance (PMSV) reporting forms anticipated by Mar...
For a Class II software-enabled device, such as an integrated continuous glucose monitoring system (iCGM), what specific documentation artifacts should a sponsor prepare to comprehensively address FDA...
For non-EU medical device manufacturers placing products on the European market, appointing an EU REACH Only Representative (OR) is often a critical step for chemical compliance. Given that medical de...
When developing a novel pharmacogenetic assessment system, a Class II device regulated under 21 CFR § 862.3364, what is a comprehensive framework for preparing a premarket submission that meets FDA's ...
For international manufacturers of clinical diagnostics, appointing a U.S. Agent is a mandatory step for market entry, but what distinguishes a purely administrative agent from a truly strategic regul...
When foreign medical device manufacturers evaluate the cost of retaining an FDA U.S. Agent, what key factors beyond a basic annual fee should be considered to ensure a compliant and effective partners...
With the EU's planned update to Post-Market Surveillance and Vigilance (PMSV) reporting forms anticipated for March 2026, how should medical device manufacturers strategically evaluate a third-party "...
For a medical device manufacturer navigating chemical compliance in the European Union, selecting the right Only Representative (OR) is a critical strategic decision. With the regulatory landscape con...
When developing a novel Class II in-vitro diagnostic (IVD) test system, especially one intended for prognostic use or risk assessment for conditions such as acute kidney injury, sponsors must navigate...
When a medical device manufacturer develops a novel Class II in vitro diagnostic (IVD), general controls alone may be insufficient to provide a reasonable assurance of safety and effectiveness. In the...
Given the critical role of the Person Responsible for Regulatory Compliance (PRRC) under the EU MDR, and with upcoming changes to Post-Market Surveillance and Vigilance (PMSV) reporting forms anticipa...
Given the evolving regulatory landscape, how can a medical device manufacturer effectively demonstrate a robust, total product lifecycle (TPLC) approach to cybersecurity within a premarket submission?...
When preparing a premarket submission for a connected medical device, such as a wearable heart monitor or an integrated continuous glucose monitoring system (iCGM), how should a sponsor structure the ...
When developing a novel Class II diagnostic device that falls under an existing classification regulation, such as a test system under 21 CFR Part 862, how can a sponsor strategically determine the ap...
As the medical device industry prepares for mandatory eSTAR use and potential updates to key standards like the ISO 10993 series, how should sponsors strategically plan and document their biocompatibi...
With the European Chemicals Agency (ECHA) increasing its focus on enforcement, particularly with projects signaling more rigorous inspections of Only Representatives (ORs) expected in 2026, how should...
When preparing a premarket submission for a connected Class II medical device, such as an integrated continuous glucose monitoring system (iCGM) identified under 21 CFR 862.1355, how can sponsors effe...