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The proposed assessment elements are intended to promote convergence of regulatory approaches, enhance technical capabilities of regulators and stakeholders and generate faster evidence. Read More
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