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17 April 2013
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The International Medical Device Regulators' Forum (IMDRF), the regulators-only medical device harmonization group, has released a long-awaited major medical device proposal for industry comment
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19 November 2012
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The US Food and Drug Administration (FDA) has unveiled a new amendment to its proposed unique device identification (UDI) rule that would accelerate the implementation schedule of the rule for certain
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15 October 2012
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A medical device-focused scientific advocacy group is calling on the US Food and Drug Administration (FDA) to make changes to a recently proposed regulation set to make big changes to the way medical
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14 September 2012
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The US Food and Drug Administration (FDA) is proposing to extend the comment period on a proposed rule that would overhaul the way medical devices are overseen by regulators, it has announced.In July
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3 July 2012
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The US Food and Drug Administration (FDA) announced Tuesday, 3 July its intent to implement a long-delayed Unique Device Identifier (UDI) rule, which would mandate most medical devices carry an
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5 June 2012
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A proposed rule by the US Food and Drug Administration (FDA) which would implement a so-called Unique Device Identification (UDI) system has been held up at the US Office of Management and Budget
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11 May 2012
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A new piece of legislation introduced in the House of Representatives by Rep. Lois Capps aims to expand postmarket tracking of medical devices and implement a mandate for the passage of a Unique
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11 April 2012
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A spat involving St. Jude Medical and the medical journal HeartRhythm escalated sharply on 10 April, with HeartRhythm rebuffing St. Jude’s requests to retract an article implying defibrillator leads
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