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Latest News | 17 April 2012

CDRH: New Pilot Seeks to Dramatically Speed up 510(k) Reviews Based on High Regulatory Quality

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A new pilot program announced by the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) aims to dramatically speed up 510(k) medical device reviews for [Read More...]

Tags: 510(k) CDRH Device FDA Gutierrez IVD Medical Device OIVD Quality Regulatory Review
Latest News | 29 February 2012

FDA Releases Most Recent Accounts of MDUFA Negotiations, Unveils Upcoming Regulations

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The US Food and Drug Administration (FDA) released a cache of meeting minutes from the February negotiations over the Medical Device User Fee Act (MDUFA) reauthorization language. The minutes give a [Read More...]

Tags: FDA Fee IVD Low Risk MDUFA MDUFA III Medical Device Minutes Negotiation Regulation Regulatory
Latest News | 2 February 2012

GHTF Releases Proposed Changes to SG5 Clinical Performance Studies for IVDs

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The Global Harmonization Task Force released a new proposed document for their Study Group 5 (SG5) category called “Clinical Performance Studies for In Vitro Diagnostic Medical Devices.” The document [Read More...]

Tags: Clinical Performance Studies GHTF IVD Proposed Document SG5