Latest News
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19 March 2013
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The US Food and Drug Administration (FDA) has accused medical device manufacturer NuVasive of marketing its Affix Spinous Process Plate Systemic device without an approved application, rendering it
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Regulatory Update
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18 March 2013
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In December 2012, China’s State Food and Drug Administration’s (SFDA) National Medical Standardization Technical Committee issued a standard (YY 0505-2012) that is equivalent to the international
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Latest News
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11 March 2013
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The US Food and Drug Administration (FDA) is over-reaching on its planned list of medical device guidance documents, claims a comment notice filed by industry group AdvaMed, which says FDA needs to
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Latest News
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11 March 2013
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US regulators have moved in recent years to better define their approach toward the regulation of so-called "mobile medical applications," or just "apps," available on smartphones and tablet devices.
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Latest News
Regulatory Update
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8 March 2013
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In the latest collaboration since Australia’s Therapeutic Goods Administration (TGA) and New Zealand’s Medsafe agreed in 2011 to proceed with a joint scheme for the regulation of therapeutic products,
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Latest News
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7 March 2013
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Medical device industry group Eucomed has a message for EU legislators in the midst of considering changes that would subject medical device products—and particular higher-risk, implantable ones—to
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Latest News
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7 March 2013
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Medical device manufacturer Medtronic has announced that its Symplicity Renal Denervation System has been accepted under a relatively new program that will see the device concurrently reviewed by both
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Latest News
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5 March 2013
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The US Food and Drug Administration (FDA) has released a new draft guidance for industry intended to clarify the types of communication used during the review of medical device product submissions
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Latest News
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4 March 2013
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Is the US Food and Drug Administration (FDA) preparing to regulate your smartphone or tablet computer? And will mobile medical applications—apps—be subject to the 2.3% medical device excise tax?
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Latest News
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4 March 2013
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The US Food and Drug Administration (FDA) has released a new guidance document on using the 510(k) pathway to clear two types of pulse oximeters, small non-invasive sensors that are used to measure a
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