Understanding the science behind drug, biological and medical devices ensures that combination products are safe for the market. The Food and Drug Administration (FDA) needs to collaborate with the Center for Drug Evaluation and Research, Center for Devices and Radiological Health and Center for Biologics Evaluation and Research — the three medical product centers — when determining the reliability of drugs and devices.
For more than 40 years, the FDA have had to understand the science behind new drugs and medical devices. Going forward, the agency can use SMART criteria, a mnemonic acronym that outlines objectives for design, purchasing, manufacturing, packaging and storing.
The process in researching the science behind medical devices should be specific. The FDA should set out a definite framework that all product centers follow, too. In June 2016, the agency said: “[We are] designing regulatory frameworks around the type of technology and its unique evidence generation and innovation cycle rather than applying a one-size-fits-all approach.” Information about funding and strategic planning should also be explicit.
Measuring success and failure is important when keeping up with the science behind new combination products. In July 2015, the agency announced a shift toward “quality metrics,” where a set of measurements will provide guidance on products submitted for approval by manufacturers.
Different objectives should be assigned to different sections of the FDA. While the CDER, CBER and CDRH already serve different functions — and the Office of Combination Products fills in the gaps — processes often overlap, making it difficult for manufacturers to know where to send a combination product.
The FDA should continue to set realistic goals. These should be listed on their website for greater transparency.
The FDA is attempting to streamline long wait times. In October 2015, new legislation provided the agency with the authority to transfer the initial combination product review process to third parties for certain devices. In the future, a specific time frame should be available for manufacturers, too.
The Role of a Project Manager
A good project manager can ensure these SMART goals are utilized effectively, helping the FDA to improve communication processes between its three product centers and get life-saving drugs and medical devices to market in a speedier time frame.
Technology is constantly evolving, making it difficult for the FDA to keep up with the science behind the latest products. However, using SMART criteria and a product manager assures products are approved quickly without safety being compromised.
Do you want to your combination product approved? Contact us at Quality Solutions Now (QSN), and we can ensure your product meets FDA compliance standards.