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Tag Archives: CDRH
Divisive Devices or UFC 510(k): FDA Meets IOM
In a previous post, I discussed the FDA’s Center for Devices and Radiological Health (CDRH) re-evaluation of the 510(k) review process for medical devices. This re-evaluation, spearheaded by the very visible director of CDRH, Dr. Jeffrey Shuren, was prompted by … Continue reading
Posted in Clinical Trials, FDA, Industry News, Regulatory Strategy
Tagged 510(k), CDRH, clinical trials, FDA, manufacturing, medical devices, PMA, postmarketing, safety
1 Comment
A Brief Update on FDA’s Re-evaluation of the 510(k) Process
Change is in the air. No, I’m not referring to the recent thaw here in Minnesota, but rather to the looming changes in the regulations governing medical devices in the U.S. First, a brief primer on the medical device approval … Continue reading
Posted in FDA, Industry News, Regulatory Strategy
Tagged 510(k), CDRH, EU, FDA, guidance, medical devices
2 Comments
CDRH Proposes Changes to the 510(k) Pathway
All for one, one for all, that is our device. – Alexandre Dumas The Center for Devices and Radiological Health (CDRH) has been somewhat under fire in recent years, so it surprised no one when it undertook a long look … Continue reading
Posted in FDA, Industry News, Regulatory Strategy
Tagged 510(k), CDRH, FDA, guidance, medical devices
Comments Off
Use A Detailed Development Plan to Secure Venture Capital
It’s a tough time to be asking for money. Whether you’re a high schooler who needs cash to gas up the ride or a fledgling biotechnology company with a hot technology, there’s not much extra to go around. In today’s … Continue reading
Posted in Venture Capital
Tagged biologics, business plan, Cato BioVentures, CDRH, development plan, drug development, FDA, venture capital
1 Comment
Device Advisory Committee Changes
If you don’t like how things are, change it! You’re not a tree. – Jim Rohn Planning on attending an Advisory Committee meeting for a medical device in the near future? If you’re a regular at them, you may soon … Continue reading
Posted in eCTD, Industry News
Tagged advisory committees, CDRH, FDA, medical devices, transparency
1 Comment
