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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

New CDRH deputies: FDA's device center is hiring two new deputies to serve under the center director: a deputy center director for policy and deputy center director for science. Applications for the two positions were accepted from early November through early December, and the agency's decision should be announced by the end of January. According to Barbara Zimmerman, a deputy director in CDRH's Office of Device Evaluation, the policy staffer will serve a similar function to the former associate director for regulations and policy, a post which has not been permanently filled since Kate Cook left CDRH in September (1"The Gray Sheet" Sept. 14, 2009). The deputy center director for science is a somewhat new position, created to tackle challenging scientific questions within FDA offices and those that rise to the level of the center director, Zimmerman said at a recent industry meeting

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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

Regulatory News In Brief

Devices for rare diseases: 1AdvaMed and 2Medtronic say FDA device reviewers should take a page from the agency's orphan drugs program and allow makers of approved humanitarian-use devices to gain market exclusivity for a time, make a profit on the devices and obtain tax credits similar to those for orphan drugs. FDA should also be able to tailor the maximum patient population size for a humanitarian-use device, the groups said in Aug. 31 comments on regulation of products for rare diseases. Currently, humanitarian-use devices must be designed for conditions that affect fewer than 4,000 patients per year. Regulators should be allowed "to selectivity raise the cap for specific conditions when FDA determines the health of orphan or pediatric patients requires an increase ... based on medical, demographic and scientific information provided by a petitioner," AdvaMed writes. In June, FDA held a workshop on regulation of products to treat rare diseases (3"The Gray Sheet" July 5, 2010)

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