“The Gray Sheet” reviewed CDRH’s proposed orders and final classification decisions on preamendment devices targeted by the 515 initiative. As of Aug. 5, FDA has proposed or finalized 14 PMAs, and proposed or finalized 10 products to be downclassified to class II with special controls.
FDA has leaned toward requiring more PMAs than 510(k)s for preamendment medical devices since it launched its focused risk classification effort in 2009. Although there have been some complaints, stakeholders generally say the agency has taken an even-handed approach to revising regulatory requirements under its “515 program initiative.”
“I think they’re using an appropriate risk-based, scientific approach, where they’re analyzing each device very carefully and making the appropriate...
EU member states have issued a consensus statement on the urgent need to build momentum to tackle governance and centralization issues as part of much-needed reform of the EU medtech regulatory system.
A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.
US Medicare has proposed national coverage of renal denervation for patients with uncontrolled hypertension. The treatment is seeing other advances as well, with Medtronic piloting a longer catheter and a multi-organ approach and a blood test to identify the best candidates fresh on the
Medtech companies require expertise to navigate complex AI regulations and integrate AI in medical software while addressing regulatory challenges, claims expert AI consultant with medtech experience.
