903 Card Requirements
Classified as a Class II Medical Device, 903 Collection Devices are manufactured and quality released in compliance with the FDA Quality System Regulation 21 CFR Part 820.QSR. Therefore, our manufacturing sites may be inspected by the Food and Drug Administration. In April 2007, GE Healthcare was audited by the Center for Devices and Radiological Health. During this process, we were successful in showing that the neonatal nards were manufactured in compliance with Good Manufacturing Practices (GMP).
We apply an IVD mark to 903 neonatal blood collection cards because they are “in vitro diagnostic” devices in both the US and EU. This shows that GE Healthcare has applied and demonstrated all applicable requirements of the FDA and European “IVD” Directive with regard to sample collection devices.
The FDA and European “IVD” directive requires that medical devices benefit patients and users by being both safe and effective. These regulatory agencies achieve this by setting out “Essential Requirements” to ensure that the device does not compromise the health or safety of the patient or user in use. GE Healthcare is responsible for ensuring that the product is both safe and effective under these guidelines in addition to meeting regulatory requirements such as the International Quality Standard for Medical Devices, ISO 13485:2003, and the Directive 98/79/EC.