Practical Guide to FDA Medical Device Submissions: 510(k), PMA and Exemption Pathways (WEBINAR)

The main market opportunities include navigating US regulatory pathways like 510(k), PMA, and DeNovo for medical device approvals. The modified 510(k) process encourages submission of new technologies ...
DrBicuspid

FDA targets improvements to 510(k) process

With an eye toward encouraging innovation, providing regulatory predictability, and ensuring patient safety, the FDA's Center for Devices and Radiological Health (CDRH) has issued two preliminary ...
RAPS

As 510(k) Process Evolves, Questions Remain

The 510(k) premarket notification process provides a clearance pathway for new, low-risk medical devices to be sold in the US by proving to the US Food and Drug Administration (FDA) that a proposed ...
Medscape

FDA Recommends Changes to 510(k) Process

August 6, 2010 (Silver Spring, Maryland) — As the Institute of Medicine continues its review of the FDA's 510(k) clearance process for devices that do not require full premarket approval (PMA) review, ...
RAPS

Prominent Lawyer Calls for Improvements to 510(k) Program, Citing 'Intolerable' Process

US regulators of medical devices, and indeed all regulators, must balance two competing needs when it comes to regulation: the desire for a process to be as simple as possible, and the desire for a ...
National Academies of Sciences%2c Engineering%2c and Medicine

Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years

Prior to the Medical Device Amendments (MDA) of 1976, medical devices generally had not undergone premarket review by the US Food and Drug Administration (FDA). The MDA created three classes of device ...
National Academies of Sciences%2c Engineering%2c and Medicine

Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report

At the request of the Food and Drug Administration (FDA), the Institute of Medicine (IOM) has convened a consensus committee to review the 510(k) clearance process for medical devices. 2 Also known as ...