Packaging Equipment Flexibility for Medical Device Manufacturers in an Evolving FDA Regulated Industry


Regulations, such as the new UDI directive imposed by the FDA to achieve tighter control over counterfeiting and illegal markets and improve efficiency in the recall process, places more responsibility on medical device manufacturers and packagers to control inventory. The new UDI directive will not permanently resolve these issues - once counterfeiters and black market traders find ways around newly implemented security measures, regulations will need to be modified again to regain control.