In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing the government shutdown and its potential impact on medical device manufacturers and their submissions. This shutdown is almost one month in, and its conclusion does not seem to be in the near future. So, what do you do if you have a device being submitted to the FDA, already under review, or some other scenario involving the agency? During this conversation, the follow...
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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing the government shutdown and its potential impact on medical device manufacturers and their submissions. This shutdown is almost one month in, and its conclusion does not seem to be in the near future. So, what do you do if you have a device being submitted to the FDA, already under review, or some other scenario involving the agency? During this conversation, the follow...
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing what the process should be for a company once they receive a 483 or warning letter from the FDA. Best practices, first steps to take, who is responsible, and potential strategies for avoiding them are shared. Specifically, the following questions are addressed: Could you please explain what a 483 is and what a warning letter is? Are they the same thing?What are some c...
Medtech Matters
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing the government shutdown and its potential impact on medical device manufacturers and their submissions. This shutdown is almost one month in, and its conclusion does not seem to be in the near future. So, what do you do if you have a device being submitted to the FDA, already under review, or some other scenario involving the agency? During this conversation, the follow...
