FDA TB test changes

March 19, 2012

THE US Food and Drug Administration has proposed a new rule aimed at encouraging the development of a type of test used to detect tuberculosis cases. The change would lower the risk classification for nucleic acid-based tests, which would in turn allow manufacturers to utilise the FDA’s more streamlined clearance pathway for medical devices. Currently nucleic acid-based tests are Class III (high risk) devices which require the more rigorous pre-market approval application. The potential move to Class II also includes a draft guidance for manufacturers which identifies measures to deal with risks to health workers handling specimens.

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Pharmacy Daily | FDA TB test changes

FDA TB test changes

Other recent headlines

RACGP slams SA move

PSA’s new vaping criteria

IPA makes room for charity

SEARCH PHARMACY DAILY

Featured video

Recent issues

INDUSTRY JOB VACANCIES