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NIH, FDA Seeking Better Methods To Evaluate MedTech Innovations

This article was originally published in The Gray Sheet

Executive Summary

A new collaboration between the National Institutes of Health and FDA will spur research into new tools and methodologies to evaluate the safety and efficacy of innovative medical products

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Regulatory News In Brief

CDRH inspections database: Center launches 1database Sept. 30 of CDRH-led medical device inspections from 2008 to present. Inspections handled primarily by the Office of Regulatory Affairs are not included in the searchable database, so the database provides access to about 25% of device inspections conducted in the past two years. CDRH leads inspections of foreign facilities, as well as inspections related to Medical Device Reporting, labeling and software issues. The database can be found on the CDRH Transparency website. Clinical trial inspections are not included "because information about new medical device development is confidential," CDRH notes

Regulatory News In Brief

CDRH inspections database: Center launches 1database Sept. 30 of CDRH-led medical device inspections from 2008 to present. Inspections handled primarily by the Office of Regulatory Affairs are not included in the searchable database, so the database provides access to about 25% of device inspections conducted in the past two years. CDRH leads inspections of foreign facilities, as well as inspections related to Medical Device Reporting, labeling and software issues. The database can be found on the CDRH Transparency website. Clinical trial inspections are not included "because information about new medical device development is confidential," CDRH notes

FDA Commissioner Sees Industry Role In Regulatory Science Initiative

Device and drug firms should have a seat at the table as FDA works to strengthen its regulatory science program and thus speed pre-market product reviews, Commissioner Margaret Hamburg says

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