Search Pharmacovigilance & Regulatory Intelligence

Companies preparing 510(k) submissions for dental composite resin devices must align with the recommendations specified in the new guidance, which include detailed testing and labeling criteria.

Manufacturers should align their premarket submissions for dental curing lights with the updated FDA guidance, ensuring to follow new recommendations on device description, performance testing, and labeling.

PV teams should revise workflows and SOPs related to regulatory submissions for blood systems, ensuring alignment with new guidance on performance data, biocompatibility testing, and regulatory pathways.