Special controls are also provided for reasonable assurance of the safety and effectiveness of the devices impacted by the reclassification.
Designers and manufacturers of both devices and software must conduct due diligence and ensure regulatory compliance in protecting user data.
This new pathway is a considerable change for the medical device industry.
The agency’s intent is to decrease regulatory burden while promoting patient access to products.
The agency’s latest announcements are indicative of its focus on risk reduction while promoting innovation.
When FDA says stop, they mean stop!
Reusable devices have become more difficult to clean, disinfect and sterilize. FDA is now requiring clear instructions for effective reprocessing.
The agency states this list of more than 1000 devices doesn’t have risks that warrant premarket notification.
Bringing a product to market in the United States can be complicated, but it can be streamlined with a clear grasp of the process.
FDA issues two new draft guidances that explain when device or software changes require a 510(k) submission.