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Latest News | 18 May 2012

Designing Efficient Clinical Trials for Glucose Sensors Focus of Upcoming FDA Meeting

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The US Food and Drug Administration (FDA) is planning an upcoming meeting to discuss the challenges of designing and implementing clinical trial designs for glucose sensors, as well as ways to improve [Read More...]

Tags: Clinical Trial Diabetes FDA Glucose Glucose Sensors Medical Device Meeting R&D
Latest News | 16 May 2012

CGMP Violations Could Lead to Three Years in Jail for Former Medical Device Executive

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The US Food and Drug Administration’s (FDA) Office of Criminal Investigations and the US Department of Justice (DOJ) have announced the indictment of William Zinnanti, the former President and Owner [Read More...]

Tags: CGMP DOJ FDA Indictment Medical Device Sterility Surgical warning letter Zinnanti
Latest News | 14 May 2012

Report: ‘Dramatic’ Increase in Q1 Medical Device Recalls

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A new report tracking medical device recalls during the first quarter of 2012 shows a massive spike in medical device recalls, reversing a fourth quarter (Q4) 2011 trend of reduced recalls.Medical [Read More...]

Tags: drug ExpertRECALL Medical Device Pharmaceutical Quality Recall report Trends
Latest News | 11 May 2012

Proposed Bill Would Mandate Passage of Device Identifier, Data Collection

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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 [Read More...]

Tags: Delay FDA Legislation Medical Device OMB Tracking UDI Unique Device Identifier
Latest News | 10 May 2012

FDA: Use of Medical Device in MS Patients ‘Unproven,’ Risky

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The US Food and Drug Administration (FDA) sent out a warning to health professionals on 10 May warning them of the dangers associated with the use of a balloon angioplasty device to widen narrowed [Read More...]

Tags: CCSVI CDRH FDA IDE Investigational IRB Maisel Medical Device MS Veins
Latest News | 10 May 2012

As User Fee Bill Sails Through House Committee Vote, a Focus on Industry Efforts

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The House Energy and Commerce Committee advanced the Food and Drug Administration (FDA) Reform Act of 2012, a package of proposals to both fund and reform the agency, by a unanimous vote involving 46 [Read More...]

Tags: Bill BIPUFA BsUFA Congress drug FDA GDUFA House Industry Legislation Lobbying MDUFA Medical Device PDUFA Pharmaceutical PhRMA Senate User Fees
Latest News | 10 May 2012

House Committee to Vote on User Fee Bill, Aiming for Passage in July

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The US House of Representatives’ Energy and Commerce Committee is set to hold a vote on Thursday, 10 May on a collection of user fee legislation being dubbed the Food and Drug Administration (FDA) [Read More...]

Tags: Bill BIPUFA BsUFA Congress drug FDA FDA Reform Act of 2012 FDASIA GDUFA House Legislation MDUFA Medical Device PDUFA Pharmaceutical Senate Upton User Fees
Latest News | 9 May 2012

FDA Issues New Draft Guidance on Pediatric X-Ray Imaging

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The US Food and Drug Administration (FDA) announced it is releasing new draft guidance for industry on what information needs to be contained with a company’s premarket notification for any x-ray [Read More...]

Tags: CDRH Draft Guidance FDA Medical Device Meeting Pediatric Warning X-Ray
Latest News | 2 May 2012

CMS Coverage Decision Based on FDA Parallel Review Program

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A decision by the US Centers for Medicare & Medicaid Services (CMS) to cover transcatheter aortic valve replacement (TAVR) procedures for patients enrolled in Medicare is among the first under an [Read More...]

Tags: CMS Edwards FDA Medical Device Medicare National Coverage Analysis NCA Reimbursement Tavenner TAVR
Latest News | 1 May 2012

Asian Harmonization Working Party Joins ISO, IMDRF

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The Asian Harmonization Working Party (AHWP) has announced it has been accepted as a member in both the International Medical Devices Regulators Forum (IMDRF) and the International Standards [Read More...]

Tags: AHWP IMDRF Inclusion ISO Join Medical Device Member Membership
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