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Regulatory research on IDE exemptions: A case study in persistence (part 1)
A client presented us with a simple question – Do we need to submit an Investigational Device...
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Regulatory Considerations for Clinical Studies: Clinical Trials for Medical Device Innovators Part II
Regulatory Considerations for Clinical Studies: Clinical Trials for Medical Device Innovators Part II. The second, in a...
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Is the Pre-Submission process worth the time and effort?
The last in a series of blogs about informal, pre-submission contact with FDA. Read the first here,...
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What happens once I submit a Pre-Submission? (Part 3: After the meeting)
The sixth in a series of blogs about informal, pre-submission contact with FDA. See here, here, here,...
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What happens once I submit a Pre-Submission? (The meeting)
The fifth in a series of blogs about informal, pre-submission contact with FDA. See here, here, here,...
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What happens once I submit a Pre-Submission? (Before the meeting)
The fourth in a series of blogs about informal, pre-submission contact with FDA. See here, here, and...
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What is involved when submitting a Pre-Submission?
The third in a series of blogs about informal, pre-submission contact with FDA. See here and here...
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When should you take advantage of the Pre-Submission program?
The second in a series of blogs about informal, pre-submission program and contact with FDA. See here...
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What do I do if I want talk to FDA before I send in a submission?
The first in a series of blogs about informal, pre-submission program and contact with FDA. You are...
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Seven ways to legally market your medical device in the U.S.
The vast majority of medical devices are marketed in the United States based on one of two...