Regulatory Affairs

EMA Publishes Draft Guidance on Combo Device Quality Requirements

The European Medicines Agency issued a draft guideline on quality requirements for combination devices, opening the guidance up to a three-month public consultation. Read More

EC Releases New Guidance on Eudamed Data Exchange

After months of criticism of the European Commission for the slow release of guidance on the EU’s new medical device regulations, the Commission released a flurry of documents on the Eudamed data exchange. Read More

Japan, South Korea Seek to Speed Device Access, Secure Safety

At the recent International Medical Device Regulators Forum (IMDRF) meeting in Moscow, Japanese and South Korean regulators said they plan to introduce mechanisms to allow for rapid access to needed devices and in vitro diagnostics. Read More

FDA Issues Final Guidance on the Q-Submission Program

CDRH released final guidance for device sponsors on requesting feedback or meetings with agency officials ahead of investigational device exemption (IDE) or other marketing submissions under the Q-Submission program. Read More

MedTech Europe Faults EU Plan for Harmonizing Standards

Harmonized standards are key for applying Europe’s new medical device and in vitro diagnostics regulations, but the European Commission’s latest draft of the standards to be considered is filled with technical errors that would result in a lack of standardization, MedTech Europe said. Read More

European Commission Issues Q&A on Requirements for Notified Bodies

The European Commission’s Medical Device Coordination Group (MDCG) released a Q&A on requirements for notified bodies (NBs) under the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR). Read More

IMDRF Releases Guidance on Pathways for Personalized Devices

The International Medical Device Regulators Forum (IMDRF) has released a draft guidance laying out regulatory pathways for personalized medical devices. Read More

GS1 Issues New Guidelines That Reflect New UDI Requirements

GS1 released updated guidance to help devicemakers comply with new unique device identifier requirements under the FDA’s updated standards. Read More

FDA Issues Alert for Beckman Coulter Blood Analyzers

The FDA issued an alert over a recall of Beckman Coulter DxH 800, DxH 600 and DxH 900 blood analyzers, updating an urgent medical device correction letter the company issued following complaints of inaccurate blood platelet counts. Read More

Stakeholders Seek More Clarity on FDA’s Combo Products Guidance

Industry stakeholders told FDA that they want to see more clarity on its guidance on combination product premarket reviews. Read More