RAPS

FDA exempts additional Class II devices from 510(k) requirements

The US Food and Drug Administration (FDA) on Tuesday finalized an order to exempt five types of Class II medical devices from 510(k) requirements, which the agency says will decrease regulatory ...
RAPS

FDA Finalizes List of 1,003 Class II Device Types Exempt From 510(k) Requirements

The US Food and Drug Administration (FDA) on Monday finalized a list of 1,003 types of class II medical devices that the agency believes do not present risks that require premarket notification review ...
Express Healthcare

Key risks in medical device development

Medical innovation is exciting. It’s thrilling to think a new therapy, device or product can improve the quality of or save ...
MD&M East

A Complete Guide to Medical Device Design and Development

Medical device design and development is a process that helps to ensure devices that go to market are safe, effective, marketable, and profitable. The process is a blueprint of the phases needed to ...
JD Supra

FDA Publishes Long-Awaited In Vitro Diagnostics Proposed Rule – Medical Device Regulations Would Apply to Laboratory Developed Tests

FDA published a proposed rule that would regulate IVDs, including LDTs, as medical devices, drastically altering the regulatory landscape for LDTs. The proposed rule would update the definition of ...