The FDA’s search for a more efficient medical device approval process continues full steam ahead with the latest announcement that the Administration is looking to leverage partnerships within the industry in order to achieve this particular goal. Although the relationship is being described as ‘informal,’ the FDA will be working together with Biocom in order to bring greater ‘clarity, predictability and transparency‘ to the pathway used by medical device manufacturers when bringing products to market.
Biocom is a 550-member-strong association of life-science corporations based in Southern California, and its latest venture with the FDA could serve as the template for more extensive official partnerships between industry groups and the regulatory body. The driving force behind the partnership experiment has been to take advantage of the technological know-how represented by organizations such as Biocom in order to give the FDA the ability to better deal with rapid advancements in the field. Specifically, Jeffrey Shuren, Director of the Center for Devices and Radiological Health, stated that tapping into the institutional knowledge base represented by groups like Biocom will help regulatory agencies streamline approval procedures by helping distinguish between information that is crucial for protecting patient safety and that which is ‘nice to know.’
Shuren also pushed for more openness regarding inter-industry relationships, calling out the need for medical device companies to share their own internal product safety and efficacy standards. Doing so, the director stated, would help companies save money when developing new devices as it would avoid the concurrent deployment of redundant assessment programs. A less guarded approach to this type of intellectual property could also help device interoperability, which is a growing concern as the use of wireless technology continues to spread throughout the industry.
It is a positive step forward to see the FDA and medical device companies come to the realization that they are essentially working towards the same goal: the advancement of health sciences through the development of safe and effective products. The results of this partnership could go a long way towards erasing the somewhat adversarial relationship that can develop between medical device developers and the Administration’s occasionally bureaucratic approval pathway.
adapted and republished from Aptiv Solutions BlogSUBSCRIBE TO OUR MONTHLY NEWSLETTER>>