The Food and Drug Administration (FDA) is providing manufacturers with information to help them win faster approval for medical devices deemed “substantially equivalent” to other devices, even if the technology of the new device is different or carries different risks. The guidance is designed to prevent defective medical devices from passing through the agency’s abbreviated 510(k) approval process, which allows faster clearance to moderate risk devices if they are similar to other devices currently on the market. The FDA has been revamping the 510(k) process since it was revealed four years ago that the faulty Johnson & Johnson DePuy ASR ... Read More
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