The primary responsibility of the Regulatory Affairs Summer Intern will be to assist the Regulatory Affairs Department with implementing a program to ensure labels for Fisherbrand medical devices are compliant with the FDA Unique Device Identification (UDI) standards. The FDA recently established a unique device identification system to identify medical devices through their distribution and use. When fully implemented, the labels of most devices will include a unique device identifier in human- and machine-readable form. Device labelers must also submit certain information about each device to FDA’s Global Unique Device Identification Database (GUDID). The public will be able to search and download information from the GUDID.
The unique device identification system will be adopted and integrated into the health care delivery system. UDI implementation is intended to improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation. This is a high profile regulatory requirement for our industry and will be a key compliance requirement for Thermo Fisher Scientific and the customers we serve. RSD and HMD sell over $155M in private label medical devices per year, and these products will be required to be properly labeled with a UDI before the initial deadline date of September 24, 2022.
The Regulatory Affairs Summer Intern will assist in implementing the UDI program for private label medical devices by conducting data gathering related to UDI with our private label medical device suppliers, interfacing with the FDA’s database to confirm that the products are properly registered, and reviewing medical device labels for accuracy. In addition, the Regulatory Affairs Summer Intern will perform the following compliance activities:
- Learn to retrieve, analyze and interpret the professional and regulatory literature to provide regulatory guidance on medical device product classifications.
- Review medical device product catalog language, product labeling and FDA Classifications.
- Review Fisherbrand medical devices according to the approval processes for FDA UDI compliance and complete controlled document records.
- Identify improvements required for compliance and communicate such improvements to the management and suppliers as appropriate.
- Revise private label medical device labeling procedural documentation as required.
- Develop templates for all required UDI required labeling.
- Identify and match electronic label records for the labeling process.
- Coordinate submission as required to GUDID (GS1).
- Match label printing to the marketing standards for private label devices.
- Coordinate with private label medical device suppliers to develop “artwork” and relevant structure for the UDI label.
- Interface with suppliers regarding standards used for barcode quality.
- Provide support to develop and update relevant Quality System documents for UDI implementation.
- Develop a basic understanding of the regulatory requirements for regulated products in the healthcare industry.
- Assist Regulatory Affairs and Quality Assurance professionals in compliance activities related to 21CFR820.