MEDIcept Insights
FDA Refuse-to-Accept (RTA) Guidance
The Federal Food and Drug Administration has revised its refuse-to-accept (RTA) policy for 510(k) submissions to clarify its guidance after the agency noted that its staff was spending too much time drafting extensive letters requesting additional information needed...
FDA Updates Special 510(k) Guidance
FDA’s Special 510(k) submission process has been around for years as an expedited method to demonstrate that the device to be marketed is at least as safe and effective (i.e., substantially equivalent), to a legally-marketed device not subject to the Premarket...
Metal Implants: FDA’s November, 2019 Immunology Devices Panel Meeting
The Immunology Devices Panel of the FDA’s Medical Device Advisory Committee met in November to discuss the topic of immunological responses to metal-containing products regulated as medical devices. The panel focused on metal-containing implants as well as dental...
Medical Device Risk Management: An ISO14971 Update
In 2000, the first edition of ISO 14971 was released as the international standard for risk management of medical devices. This year, the ISO technical committee (ISO/TC 210) has been hard at work updating this globally-recognized standard. And while the fundamental...
Europe’s New Medical Devices Regulation: Ready or Not, Here It Comes
For the past 30 years, the European Union’s medical device market has been regulated by the Medical Devices Directive (MDD). The rapid development of hybrid technologies, tensions between EU member states, and highly bureaucratic procedures for resolving disputes made...
Artificial Intelligence: What you need to know about next-gen smart medical device compliance
Recent strides in artificial intelligence (AI) and machine learning technology is opening the door to the development of increasingly smart medical devices capable of turning big data and digital information into actionable insights for healthcare professionals. AI is...