A large percentage of device rejections and detentions are a result of improper labelling. The Food and Drug Administration has strict regulatory requirements that need to be fulfilled before the label is approved. It involves far more than simply stating what the device does and what directions are to be followed.
The stakes are high in medical devices,which can alter the life of the user (patient) in both a positive way and at worst negative way. Hence, labelling becomes an important bridge to cross before the consumer or supplier has enough confidence in the device to make purchases.
The FDA wants the content of the label to be precise, especially when it comes to the display of chemicals, safety data, and bad effects. Hence, it is the responsibility of manufacturers to comply with these requirements or hire a competent and experienced agency that can point out where the scope of improvement is and suggest crucial corrections to increase the chances of approval.
We at Cert3global understand the sensitivity and importance of a good product label and help our clients by providing labelling services to ensure their label complies with FDA regulations and the whole effort is not wasted just because of labelling. Contact us now to increase the chances of your approval.