Regulatory Update
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11 April 2013
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Brazil’s National Health Surveillance Agency (Anvisa) has signed a technical cooperation agreement with two other Brazilian agencies designed to sustain the country’s economic growth and health by
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Latest News
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10 April 2013
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The European Commission (EC) has announced the release of its recommendation on a framework for a unique device identification (UDI) system for medical devices marketed in the EU, bringing the country
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Latest News
Regulatory Update
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10 April 2013
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The UK cost containment agency, the National Institute for Health and Care Excellence (NICE), recommended on 9 April 2013 reimbursement for two in vitro diagnostic (IVD) devices for detecting
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Latest News
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9 April 2013
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The US Food and Drug Administration's (FDA) device regulatory division wants to know: Are medical devices meeting the unique needs of women?That question is behind a newly announced workshop the
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Latest News
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9 April 2013
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Andrew von Eschenbach, the former commissioner of the US Food and Drug Administration (FDA), hasn't been quiet about his thoughts on his former agency since leaving the agency. But now he's turning
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Latest News
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5 April 2013
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The most recent meeting of the International Medical Device Regulators Forum (IMDRF), the regulators-only successor group to the Global Harmonization Task Force (GHTF), indicates that the organization
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Latest News
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4 April 2013
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A new guidance document published by the US Food and Drug Administration (FDA) establishes and otherwise clarifies the process by which biopharmaceutical and medical device companies need to pay user
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2 April 2013
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Nearly a year and a half after first announcing an experimental pilot program that would allow its medical device review staff to better understand how the regulatory process occurs from the
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2 April 2013
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The use of registries—patient and otherwise—in regulatory circles is something of a recent and surging phenomenon. If regulators can get a better sense of the data behind some of the toughest or most
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Latest News
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27 March 2013
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A new guidance document published by the US Food and Drug Administration (FDA) establishes standards by which manufacturers of in vitro diagnostic (IVD) devices intended to detect the presence of
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