Medical Device Labeling Consulting Services|Makrocare

 Medicine / Posted 2 weeks ago by david bhagya / 12 views

┬áMedical device ‘labeling’ as the term is , as defined by the Food Drug and Cosmetic Act (FDCA), exceeds just the printed label on the device and will encompass all device’s accompanying brochures, manuals, marketing materials and websites. Claims that surpass the clearance, the approval, or the applicable FDA regulation will cause the medical device to leap into an unapproved medical device category and therefore subject to FDA enforcement’s.