Tuesday 20 February 2018

All posts tagged device

Shutdown Delays Medical Device Approvals (510(k)s)

October 4, 2013 | No comments

As the shutdown continues the impact continues to be felt.  Some disruptions are expected, but given the broad and general […]

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Looking Before Leaping into Latin America – Registration Holders

December 3, 2012 | No comments

Not long after successfully selling a medical device in the US (or perhaps even the EU) manufacturers and developers look to expand […]

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ANVISA Calls Off Strike

September 10, 2012 | No comments

ANVISA, Brazil’s medical device market regulator, called off a  strike that began in July. The decision to strike jeopardized foreign manufacturers’ importation […]

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FDA Commissioner: Device Approvals Process Set to Become Less Burdensome

August 24, 2012 | No comments

The head of the FDA, Commissioner Margaret Hamburg, “sounds an optimistic tone” claiming approval process for medical devices is about to become considerably […]

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Brazilian Regulators Go On Strike – ANVISA

August 3, 2012 | 1 comment

In mid-July Brazilian government officials, including those at the regulatory agency ANVISA, walked-out on strike, leaving the agency critically under-staffed. As […]

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Guest Editorial: Rebuttal to FDA’s Internal Report on EU Medical Device Regulation

July 24, 2012 | No comments

Guest Editorial from Robert Packard, Sr. Manager, Regulatory Affairs at Delcath Systems, Inc.: In February, at a press conference in Brussels, […]

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FDA Extends Comment Period on 510(k) Guidance

November 14, 2011 | No comments

The FDA has extended the public comment period for its draft guidance on medical device 510(k) clearance for modified devices. […]

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