The regulatory pathway would allow companies to undergo a two-stage process by which devices are approved once as each of its components and once as a holistic review of the devices.

F ive years after promising to fix a flawed regulatory pathway widely used by medical device manufacturers, the Food and Drug Administration has issued new guidelines to improve its so-called 510 ...

Start-ups in the medtech space face many challenges on the way to market, not the least of which is how to prepare for, and comply with, medical device regulations. Here are some points to consider.

The FDA wants to make substantial changes to the regulatory pathway through which most medical devices enter the U.S. market. The clearance procedure has been in place since 1976.

In 2018, the Food and Drug Administration announced several actions relevant to the 510(k) premarket notification regulatory pathway. AGG has previously written about some of these, such as the ...

21st Century Cures Act and Medical Device Regulatory Pathways by: Michele L. Buenafe , M. Elizabeth Bierman of Morgan, Lewis & Bockius LLP - Law Flash Friday, December 9, 2016 ...

Developing a regulatory pathway to evaluate and improve technical documentation, including evaluation of your analytical and clinical data, deploying an ISO 13485 certified quality management system ...

Malaysia has made historic advancement in international regulatory collaboration with the launch of the Medical Device ...

FDA Changing Medical Device 510(k) ... the market being based on mesh that was around prior to implementation of FDA regulations for medical devices in 1976. ... and Performance Based Pathway" ...

South Korea’s medical device market is rapidly expanding, driven by technological innovations and increasing healthcare demands. As the market grows, understanding Korean medical device regulations is ...

These seven key provisions will affect the premarket requirements for medical devices. The US Senate passed the 21st Century Cures Act on December 7, and President Barack Obama is expected to sign ...