Medical Device Regulatory Affairs Newsletter Archives

JULY 2008 MONTHLY TOPIC:
Recent Developments Relating to 513(g) Requests for Classification

JULY 2008 ISSUE:
• CMS Gains Ability to Cover Preventive Services
• FDA Launches Two-Year Fellowship Program
• NICE Appeal Panel Denies Cordis Appeal
• Chinese Government Focuses on Corruption in Medical Device Sales
• CDRH Matrix Postmarket Safety Organization Launches 
• FDA Considers Revisions to Quality System Regulation
• FDA Increases Software Forensics Capabilities 
• Artificial Disk Trials Challenge Manufacturers
• Intel Gains 510(k) Clearance for Remote Care and Monitoring Device
• FDA Warns Against Possible Device Malfunctions
• India to Create Medical Device Regulatory Body
• Durable Medical Equipment Legislation Goes to President

JUNE 2008 MONTHLY TOPIC:
FDA Initiates Reclassification of Full Field Digital Mammography Systems

JUNE 2008 ISSUE:
• Section 513(g) Filings Often Unnecessary
• Proposed Legislation will Seek to Overturn Supreme Court Decision
• FDA Cites Software Problems as Cause of Medical Device Malfunctions
• Synergo Combination Product Recommended for Approval
• HHS Amends Budget Request for FY 2009
• Recommendations for Gender-Specific Cardiovascular Studies Under Development
• FDA Staffer Stresses Link Between Human Factors and Adverse Events
• Congress Seeks to Delay Medicare DME Bidding Program
• FDA Considers 510(k) Status for Balloon Catheters
• Abiomed’s Impella 2.5 Receives 510(k) Clearance
• FDA Issues Digital Mammography Draft Guidance
• FDA Proposes Breast Cancer Patient Registry

MAY 2008 MONTHLY TOPIC:
Recent Pressure to Reform the 510(k) Regulatory Pathway Points to Possible Shift in FDA’s
Acceptance of Combination Predicate Arguments  

MAY 2008 ISSUE:
• FDA Launches Electronic MDRs
• Gainsharing Reported to Reduce the Price of Medical Devices
• FDA and CMS Team Up for Sentinel Initiative
• CMS to Consider National Coverage for Virtual Colonoscopy
• Patient Safety Coalition Pushes for Unique Device Identifiers
• Opposition Voiced Against Proposed Additional FDA Inspections and Fees
• Task Force Issues Standards Guidance
• $275 Million for FDA Cleared by Senate Panel
• FDA Commissioner Asks Congress for Additional $275 Million
• Import Safety Bill Under Consideration in Congress
• FDA to Examine Toxicity of BPA
• CMS Proposes to Grant Five New Codes for Durable Medical Equipment
• CMS Grants National Coverage for Replacement Heart
• CDRH to Hire 116 New Staffers in Fiscal Year 2008
• Molecular Diagnostics Firm Submits Two HPV PMAs

APRIL 2008 MONTHLY TOPIC:
Recent Developments in the Dissemination of Publications on Off-Label Uses

APRIL 2008 ISSUE:
• FDA Panel Recommends LASIK Labeling Changes
• FDA Clears Yulex Patient Examination Glove
• OIVD Gives Advice on Pre-IDE Meetings to Diagnostic Device Firms
• CMS Seeks FDA Input on Medicare Device Coding Applications
• FDA Announces Approval of First Compact Heart Assist Device
• FDA Publishes Draft Clinical Trial Certification Guidance
• House Releases Draft Bill to Improve Device Import Safety
• CMS FY 2009 Inpatient Payment Proposal Includes "Charge Compression Fix"
• Health Care Groups Lobby for Timeline for Unique Device Identifiers
• FDA’s Labeling Rule Criticized by Lawmakers
• FDA Looks for Creative Approaches to Pediatric Trials
• FDA Approves Talent™ Abdominal Stent Graft
• FDA Expected to Increase Prosecutions
• DME Manufacturers Unhappy with Competitive Bidding Results
• Report Calls for Greater Diversity in Clinical Studies
• Drug-Eluting Stent Firms Collaborate on Major Trials
• FDA Releases Draft Guidelines for Drug-eluting Stents
• FDA and Industry Oppose Potential Legislative 510(k) Reform
• CDRH Staffer Calls for Real World Device Trials
• International Sharing of GMP Inspection Results on the Horizon

MARCH 2008 MONTHLY TOPICS:
Recent Developments in Federal Preemption Under the Medical Device Amendments of 1976

MARCH 2008 ISSUE:
• CDRH Director Alludes to an Increase in 510(k) Data Requests for Certain Devices
• FDA Investigates Effect of Radio Interference on Implantable Devices
• Legislators to Introduce Preemption Amendment
• Medicare Competitive Bidding May Save Billions
• Third Wave’s Cystic Fibrosis DNA Test Gains FDA Approval
• Device Industry Experts Warn of FCPA Investigations
• PMA Preemption Unclear for Combination Products
• FDA Publishes Updated Guidance on Expedited Review
• FDA’s Radiological Devices Advisory Panel Recommends Testing of Concurrent and Sequential Mammography CAD
• GAO:  Reprocessed Single-Use Devices Are Safe
• Device Expert Calls for More Consumer Protection
• FDA Science Board Calls for Budget Increase
• FDA Looking to Open International Offices
• Standard Template for Recall Press Releases Proposed
• FDA Approves Amniotic Fluid Detection Device
• FDA Genetic Test Oversight to Increase
• Lawmakers Threaten to Overturn Supreme Court Preemption Decision
• Device Industry Looks to Civil Settlements for Compliance Standards

FEBRUARY 2008 MONTHLY TOPIC:
Mammography CAD

FEBRUARY 2008 ISSUE:
• New Combination Products Chief Named
• FDA Proposed Rule Would Relax Restrictions on Off-Label Promotion
• Draft HHS Regulation Offers Discreet Adverse Event Reporting
• New Guidance Documents Released
• President’s FY 2009 Budget Would Cut Ten CDRH Staff Positions
• CMS Again Considers Carotid Artery Angioplasty Coverage Decision
• CryoLife Receives 510(k) Clearance for Pulmonary Heart Valve
• CAD Advisory Panel to Meet in March
• FDA Technology Update Underway; More Funding Needed
• Motivation for FDA’s Off-label Promotion Guidance Investigated
• FDA Releases Final CLIA Waiver Guidance; Industry Reacts
• FDA Releases Medical Glove Guidance Manual
• CMS Looks to National Oncologic PET Registry as Model for Imaging Coverage
• FDA Seeking Comments on Small Business Qualifications
• St. Jude’s QuickFlex Leads Receive FDA and CE Mark Approval
• BayBio Calls for Federal Reforms

JANUARY 2008 MONTHLY TOPIC:
Conflicts of Interest and FDA Advisory Committee Members Under the
Food and Drug Administration Amendments Act of 2007

JANUARY 2008 ISSUE:
• CMS Considers National Coverage Policy for Thermal Disc Therapies
• New Portal for FDA Dockets
• Approval Required for Most Labeling Changes
• Priorities for 2008 Shaped by FDA User Fee Commitments
• FDA and NIH Partner to Centralize Adverse Event Reporting
• FDA Publishes Guidance Documents on PMA Manufacturing Audits and Clinical Trial Inspections
• FDA to Establish Staff Positions Globally
• CMS to Expand DMEPOS Competitive Bidding
• New Initiatives Create Market for Novel Device Interventions for Preventing Hospital-Acquired Infections
• Medicare Device Provisions Still on the Table for 2008
• For-Cause Inspections Reveal 10-Year High in Clinical Trial Violation Rate
• ClinicalTrials.gov Certification to Accompany Premarket Submissions
• FDA Petitioned to Require Additional Information on DTC Device Ads
• Growing Orthopedic Implant Market in India
• FDA Releases New Guidance Document: Interactive Review for Medical Device Submissions: 501(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements
• Representatives Concerned About Medicare Cuts
• Voluven Receives FDA Approval
• Device Firms Advertise Directly to Consumers
• Barriers to Adoption Prevent Innovative Technologies From Coming to Market
• FDA Expert:  User Fees are Destructive
• FDA Risk Committee to Assess Publication of Product Safety Information
• Supreme Court Likely to Find in Favor of PMA Preemption
• Ad Hoc Panel Finds FDA Scientific Expertise Inadequate to Handle New Device Technology
• FDA-Duke Clinical Trial Initiative Focuses on IRB Reform
• New FDA Guidance Document: Consensus Standards
• Proposed eMDR Rule Due in February