Regulatory Device Approval for Stroke

Regulatory device approval for stroke: fair and balanced?

See related article, pages 1988–1992. Dr Peña et al provide a regulatory perspective on the Food and Drug Administration’s (FDA) device approval process.1 Reflecting the growing importance of the topic, this is the second such review and accompanying editorial comment to appear in Stroke,2,3 the first being prompted by the FDA’s clearance of the MERCI retriever device.4 For those more familiar ...

Medical device development: from prototype to regulatory approval.

The treatment of cardiovascular disease has changed dramatically over the past 2 decades, allowing patients to live longer and better-quality lives. The introduction of new therapies (both drugs and devices) has contributed much to this success. Nowhere has this been more evident than in interventional cardiology, where percutaneous coronary intervention has evolved in the past 2 decades from a...

Biosimilars: part 1: proposed regulatory criteria for FDA approval.

Biosimilars, although not identical to their originator product, are expected to become essential in reducing health care costs and improving access to lifesaving drugs. The FDA must find a way to balance rigorous testing to ensure quality, as is done for generic chemical drugs, with providing a cost-efficient way to expedite approvals of these products.

New isotope manufacturing methods head for regulatory approval.

Express preemption and premarket approval under the Medical Device Amendments.

Millions of dollars are spent each year in an effort to develop new medical devices designed to help individuals facing serious medical conditions. However, before these devices can reach consumers, they must be reviewed and cleared by the Food and Drug Administration ("FDA"). Innovative medical devices which pose the greatest risks and are aimed at helping the most critically ill consumers are...