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The FDA has asked Congress to consider several proposed authorities that would affect medical device developers, manufacturers and distributors. Read More
MichClone Associates, a medical device manufacturer in Troy, Mich., has received a seven-observation Form 483 from the FDA for deficiencies observed during an inspection late last year. Read More
Synchron’s Stentrode investigational brain-computer interface device has been found safe and effective in a small study of patients with paralysis caused by amyotrophic lateral sclerosis (ALS). Read More
President Biden’s fiscal 2023 budget request for the FDA calls for an increase of almost 10 percent in funding for regulation of medical devices. Read More
The European Commission’s Medical Device Coordination Group (MDCG) has released new guidance on compliance of high-risk devices such as pacemakers and prosthetic heart valves with the EU’s Medical Device Regulation (MDR). Read More