It is surprising how little many people in the medical device industry know about freely-, widely-available resources. Often, many do not know how easy it is to find the regulations and the preambles, or about the existence of Food and Drug Administration mailing lists, phone directories and databases. MedTech Intelligence presents a basic list of non-commercial regulatory reference links, most from FDA itself. Undoubtedly, we have missed some. Send us your suggestions to make this a ‘living, growing’ list.
It’s too early to tell how the new administration will affect the device industry, but user fees, the ACA and the FDA regulatory process are top of mind.
From increasing focus on reimbursement and economic value, to impact of UDI and the medical device user fees, three industry experts discuss current market and regulatory trends and challenges shaping the medical device industry, and offer some effective strategies for companies to follow to remain competitive.
Chinese medical device market regulator China Food and Drug Administration (CFDA) has published a draft table of user fees for medical device registrants, and is expected to begin enforcing fee requirements in March 2015.