With the second phase of UDI compliance dates coming in less than a year ( September 2015) for medical devices to require UDI labeling; it is imperative that organizations continue to advance their preparations to begin implementation of these labeling requirements and that preparation begins with populating the UDI database known as GUDID(Global Unique Device Identification […]
A great article from Med Device Online regarding the recent and upcoming changes to UDI compliance. These new regulations coming into affect will ensure proper information and identification is attainable to the consumer for proper use and understanding of the product. To view the full article click the link below: http://bit.ly/1DwOK0S
Due to the overwhelming demand for updates to ISO 13485 which regulates medical device compliance; we expect to see some important changes by quarter 1 of 2016. The biggest revision expected is the compliance with international regulations; ensuring consumers that these devices have been tested and meet all safety requirements across the globe is […]
The FDA’s ruling for medical devices to carry a UDI (Unique Device Identification) will go into effect on September 24th. This will allow easy and definitive attributes of a medical device reducing errors in misidentification or improper use. Making these necessary can be a costly task for companies who aren’t prepared. That is where Pragmatyxs […]
Former FDA commissioner David M. Kessler is proposing the FDA extends their label regulations to the front of food packaging. With these regulations in place the consumer will be able to make more conscious decisions when selecting products that meet their needs. Also detailed in Kessler’s proposal is to aggregate related ingredients (i.e. sugar) to […]
Developers and researchers can now access and recalled drugs, medical devices as well as human and animal food product dating back to 2004.OpenFDA has created a weekly updated API that allows users to research any recalled product. Many of the recalls found in the report are product that have incorrect labeling or pose health and […]