Opportunities exist for enhancing medical device safety and compliance through improved labeling that meets regulatory standards. These include employing clear information, symbols to bridge language ...

Medical device makers are feeling the weight of the Food and Drug Administration’s unique device identifier regulations. Loftware and USDM Life Sciences conducted a nationwide survey that polled ...

In today’s world – whether at work or at home – I’d be lost without the smartphone that helps me do so much more than just communicate. It knows where I am now and how to get where I want to be next.

Starting in September, class II medical devices will be required to be equipped with a unique device identifier to be in compliance with UDI regulations. The U.S. Food and Drug Administration passed ...

Citing the growing number and increasing complexity of medical devices, FDA is seeking industry input about the advisability of a unique device identifier (UDI) system. The agency mandated a similar ...

The FDA’s device center has posted a draft guidance that addresses unique device identifier (UDI) code requirements applied to low-risk products. The select update offers enforcement discretion in ...

Recent regulatory reforms to Australia’s medical device framework have shown Australia’s Therapeutic Goods Administration (TGA) a new way of collaborating with industry to make improvements and ensure ...