How does the FDA approach the regulation of 3D-printed medical devices?

8 days ago ... Laser endoscopy ophthalmic system receives FDA 510(k) clearance · Study: Home OCT impacts physician decision making · FDA does ... The mean IOP ... Apr 17, 2025 ... Leos is supported by emerging data from a randomized controlled clinical trial, further validating its safety and efficacy. Nov 22, 2024 ... The US Food and Drug Administration (FDA) 510(k) clearance of remote scanning and remote protocol adjustment features on Philips Radiology Operations Command ... Dec 22, 2021 ... The FDA clearance is based on data from multiple studies of the ... mean tear film breakup time and meibomian gland secretion score ... Apr 16, 2017 ... FDA's analysis of whether to exempt a type of device from the 510(k) requirements is specific to the devices within the generic category in ... Feb 14, 2025 ... The goal of the 510(k) submission is to demonstrate that the device is "substantially equivalent" to a device that has already been cleared by ... Leading letter “K” indicates 510(k) clearance, or Premarket Notification. This is an .exact field. It has been indexed both as its exact string content, and ... Mar 7, 2022 ... Section 510(k) is a section of the Food, Drug and Cosmetic Act (FD&C Act) that requires device manufacturers to provide the Food and Drug ... Jul 3, 2024 ... What exactly does this mean? I have heard this tossed around for some time and want to learn more about the specifics of a FDA 510(k) ... Feb 4, 2025 ... FDA clearance through the 510(k) process means the agency agrees ... What does it mean to be 510(k) exempt? Some medical devices are ...