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Tag Archives: medical devices
August 2011 FDA Guidances
Here’s a (very lengthy) list of the guidances released by FDA in August 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (Draft) Postmarket Surveillance Under Section 522 of the … Continue reading
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
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New FDA Guidances Released in July 2011
Here’s a list of the guidances released by FDA in July 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device In Vitro Companion Diagnostic … Continue reading
New Guidances from FDA – June 2011
Here’s a list of the guidances released by FDA in June 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. Q11 Development and Manufacture of Drug Substances (Draft) Applying Human Factors and Usability Engineering to Optimize Medical Device Design (Draft) … Continue reading
Posted in FDA, Industry News, Regulatory Strategy
Tagged biologics, cancer, Cato Research, FDA, guidance, IDE, in vitro diagnostics, manufacturing, medical devices, OTC, PMA
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New Guidances from FDA – May 2011
Here’s a list of the guidances released by FDA in May 2011 (along with a couple that were released inthe first week of June), compiled by Cato Research Regulatory Scientist Cathy Anderson. Commercially Distributed In Vitro Diagnostic Products Labeled for … Continue reading
Posted in FDA
Tagged ANDA, clinical investigator, FDA, financial disclosure, guidance, in vitro diagnostics, labeling, medical devices, submissions
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