42nd Annual ISPE Meeting

The FDA has cleared the first over-the-counter continuous glucose monitor for children as young as two who do not use insulin, establishing OTC Glucose Monitoring Children as a practical new option for families. This

The FDA Medical Device Exemptions target specific unclassified preamendment devices that present minimal risk to patients. By exercising enforcement discretion, the agency no longer expects manufacturers to submit 510(k) premarket notification applications for these products until a formal exempt...

Successful medtech reimbursement strategies must be developed in parallel with regulatory approval, because clearance only confirms safety and efficacy while payers separately decide financial coverage. Investors now routinely demand evidence of sustainable payment pathways long before regulatory...