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Tag Archives: 510(k)
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
FDA Ups the Ante on Transparency
Transparency is not the same as looking straight through a building: it’s not just a physical idea, it’s also an intellectual one. – Helmut Jahn I’ve talked about its transparency initiative before (here, here, here, and here), but the FDA’s … Continue reading
Posted in FDA, Industry News
Tagged 510(k), ANADA, ANDA, biologics, BLA, drugs, exclusivity, FDA, medical devices, NADA, NDA, patent, PMA, transparency
2 Comments
