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The FDA rolled out its new Premarket Approval Application Critical to Quality pilot program, created to give PMA applicants the option to speak with the FDA on development of CtQ controls for their devices and to forego the standard PMA pre-approval inspection. Read More
The International Medical Device Regulators Forum is inviting stakeholder comment on a draft proposal for using real-world data from patient registries in regulatory decisionmaking. Read More
Devicemakers should also submit device classification applications to seek classification determination opinions for any new devices not covered by the catalogue or notices. Read More
The International Medical Device Regulators Forum agreed to a new work item proposal to develop technical documents that support a harmonized approach to defining devices manufactured for individual patients. Read More
The letter urges the leaders to adopt the EU’s new regulations covering medical devices and IVDs to encourage global harmonization and to keep EU-wide networks strong. Read More
The UK’s Medicines and Healthcare products Regulatory Agency plans on issuing guidance on co-developing medicines and IVDs in the near future. Read More