Even if you have not had a recall, or your products are not in the top medical specialties cited in this article, there is a good chance your Quality Management System (QMS) is also vulnerable to deficiencies in these areas.
A warning letter is the agency’s way of giving you a final chance. Behave, or you will face painful enforcement actions such as a recall, seizure, civil money penalties, or worse still, jail time for responsible individuals. It carries a big stick, and predictably, manufacturers have been quite fearful of receiving a warning letter.
Medical devices save lives, but they are not without risk. Whether it is a disposable soft contact lens used on a daily basis, or an intraocular lens surgically implanted to treat cataract, use of medical devices can potentially result in serious injury or even death. There are thousands of medical devices on the market, but there are also reports of millions of injuries and thousands of deaths associated with these devices in the last 10 years.
Recently, I had an opportunity to hear directly from FDA leaders during a fire-side chat at the Xavier Health AI Summit in Cincinnati, OH. Alonza Cruse, Director, FDA - Office of Regulatory Affairs and Bakul Patel, Associate Director, FDA – Center for Devices and Radiological Health, each shared their views on how AI is shaping FDA’s thinking in nearly all of its operations. It was very encouraging to hear that the FDA wants to build a collaborative relationship with the industry and “stand out of your way” to help realize the true potential of AI in Healthcare.