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Medical Device Regulatory Affairs Headlines

AUGUST 2010 ISSUE:

  • FDA Publishes Report on 510(k) Reform.
  • Report Examines Use of Science in FDA Decisions.
  • Advisory Panel Process May Be Tweaked Further.
  • FDA, FCC to Collaborate on Wireless Devices.
  • IOM to Begin Private Deliberations on 510(k) Program.
  • Industry Comments on New Infusion Pump Requirements.

JULY 2010 ISSUE:

  • Industry Opposes Plan to Publicize Pre-Market Information.
  • Workshop Addresses Regulation of Lab-Developed Tests. 
  • FDA Retracts Pediatric Data Rule.
  • Preventive Screenings May Increase Due to Health Reform.
  • FDA Developing Luer Lock Standard.
  • FDA and CMS Publish Data-Sharing Memo. 
  • FDA Grappling with Regulation of Cytogenetic Tests.
  • Industry Weighs in on Home-Use Device Initiative.
  • FDA Reaches Out to Diabetes Test Makers.
  • Government Explores Ways to Speed Innovation.
  • Industry Requests Reform of Humanitarian Device Program. 
  • Court Ruling Applauded by Diagnostic Firms. 

JUNE 2010 ISSUE:

  • FDA to Publish Reform Plans Soon.
  • Agencies Seek to Streamline the Marketing and Reimbursement Review. 
  • New Regulatory Path Proposed for Novel Devices.
  • Industry Input Sought for FDA Regulatory Science Initiative.
  • IOM Holds Second Meeting to Discuss 510(k) Program. 
  • Industry Questions FDA Requirement for Pediatric Data.
  • FDA Devising Plan for Oversight of Laboratory Developed Tests.
  • FDA Exerts Authority over Genetic Tests. 
  • Industry Seeks to Improve Safety of Radiation Therapy Devices. 
  • Medical Innovation Advocacy Group Issues New Report.
  • FDA, NIH Discuss Synchronizing Clinical Trial Requirements.
  • Regulators Continue to Seek Improvement in Infusion Pumps.
  • FDA Publishing Decision Memos on Device Approvals. 
  • Government Turns to Devices to Meet Public Health Need.
  • FDA Conducts Workshop on Infusion Pumps. 
  • Group Says Radiation Equipment Should be Harmonized. 
  • FDA Meeting Prompts Discussion of Wireless Home-Use Devices.

MAY 2010 ISSUE:

  • FDA Proposes Publicizing Device Information Before Marketing Approval.
  • Increase in Device Recalls Concerns FDA.
  • Device Complexity May Play Role in Radiation Therapy Errors.
  • Industry Expresses Anxiety at 510(k) Forum.
  • FDA Creates Postmarket Surveillance Program for Devices.
  • Report Urges Collaboration in Designing Medical Technologies.
  • Agency Calls for New Diabetes Tests.
  • FDA Misses Targets for Premarket Review of Devices.
  • FDA to Create Device Epidemiology Network.
  • FDA Weighs in on Non-inferiority Device Trials.
  • FDA Panels Will No Longer Vote on Device Approval.
  • New Guidance Issued on Device Classification Requests. 
  • FDA Guidance on Companion Diagnostics Proves Challenging. 

APRIL 2010 ISSUE:

  • FDA to Improve Regulation of Home Use Devices.
  • EU to Institute Mandatory Centralized Device Database.
  • New Guidelines Issued for Research and Clinical Use IVDs. 
  • FDA to Address Safety Problems Related to Infusion Pumps.
  • FDA Cooperation with Industry Decreasing, Groups Say. 
  • FDA May Increase Prosecution of Executives.
  • Agency Advises on Use of Foreign Data in Premarket Submissions.
  • Online Tool Will Track FDA Performance.
  • FDA Evaluating Review of Radiotherapy Devices.
  • Personalized Medicine Provides Opportunity for Device Companies. 
  • FDA to Require Pediatric Information in PMA Submissions.
  • Industry, Clinicians, FDA Seek to Reduce Radiation from Imaging.
  • Judge Invalidates Breast Cancer Gene Patents. 
  • Special Controls Proposed for Certain Device Types. 

MARCH 2010 ISSUE:

  • Industry Weighs in on FDA Authority to Rescind 510(k)s.
  • GAO Report Encourages FDA to Focus on its Staff.
  • FDA Urges Quality Focus to Prevent Warning Letters.
  • Industry, FDA Discuss Improving Transparency.
  • Broadband Plan Seeks to Address E-Health Products.
  • House Decides on Excise Tax for Device Sales. 
  • FDA Considering Tougher Regulation of Blood Glucose Meters. 
  • FDA Seeking to Provide More Timely Updates.
  • New Human Factors Standard to be Issued Next Month.
  • Sunshine Provisions Seem Set in Stone.
  • Industry Comments on FDA Use of New Science in Device Regulation.
  • IOM Holds First Meeting Regarding 510(k) Program.
  • Device Firms Urge Restraint in Regulation of Internet Content.
  • ODE Director Leaving FDA this Month.
  • FDA, NIH to Improve Evaluation of New Technologies.
  • FDA Moves to Regulate Health Information Technology Software.
  • FDA Formulating Guidance on Companion Diagnostics.

FEBRUARY 2010 ISSUE:

  • FDA, Industry Discuss Challenges to 510(k) Program.
  • Industry Calls for Higher Payments for New Technologies. 
  • FDA Seeks to Reduce Radiation from Imaging. 
  • 510(k) Task Force Convenes Comparative Effectiveness Meeting.
  • Industry Calls for Exemption of Tests from FDA Review.
  • FDA Needs More Funding, Hamburg Says. 
  • Obama’s Budget Would Create National Device Registry.
  • Medical Imaging Easily Reviewed on Handhelds.
  • Lack of Insurance Hinders Colorectal Screening.
  • FDA Will Hold Public Meeting on 510(k) Pathway. 
  • Industry Seeks Streamlined Event Reporting for Combination Products.
  • Workshop on Interoperable Device Systems Raises Difficult Regulatory Pathway Questions.

JANUARY 2010 ISSUE:

  • Shuren Takes the Helm at CDRH, Issues Agenda for 2010
  • FDA Issues Guidance on Heart Valve Clinical Studies
  • Device Firms Struggling with Corrective and Preventive Actions
  • Radiological Devices Review Moves to OIVD
  • FDA Promises Tougher Standards for PMA Trials.
  • Device Industry Questions Applicability of Pilot Sentinel System.
  • Device Firms Mobilize to Provide Aid to Haiti.
  • NIH Spent $40 Million on Comparative Studies of Devices.
  • Industry Pushing FDA for Companion Diagnostics Guidance.
  • Contrast Imaging Guidance Published, Concerns Remain.
  • FDA Inspections to Increase, Tougher Responses Expected.
  • Industry Still Focused on Device Tax as Negotiations Continue.
  • Coalition Urges Use of Technology to Curb Imaging.

DECEMBER 2009 MONTHLY TOPIC:
Requirements for Disclosure of Financial Ties Between Physicians
and the Medical Device Industry Gain Momentum in 2009

DECEMBER 2009 ISSUE:

  • FDA Seeks Feedback on Incorporating New Science. 
  • Infection Surveillance Saves Money, More Data Needed on Rapid Tests. 
  • Researchers Claim Medical Device Studies Not Robust. 
  • FDA Says Not to Rely on Previous Decisions for 510(k) Submissions. 
  • Panel Recommends Randomized, Controlled Trials for Prostate Cancer Devices.
  • New FDA Chief Counsel Appointed. 
  • Device Industry Groups Lobby for Modifications to Device Tax.
  • Firms Give Advice on eMDR Submission.
  • UDI Pilot Test Report Makes Recommendations to FDA.
  • Task Force Publishes Quality System Guidance.
  • Patients Could See Benefits of Comparative Effectiveness Research Soon.
  • CMS to Reimburse for PET, When Used in Clinical Studies.
  • Device Industry Comments on Electronic MDR Rule.
  • Problems Abound with Adverse Event Reporting on ClinicalTrials.gov.
  • Health Reform Will Affect Laboratory Test Reimbursement, Too.

NOVEMBER 2009 MONTHLY TOPIC:
FDA Holds Forum on Advertising and Promotion with Social Media Tools

NOVEMBER 2009 ISSUE:

  • Senate Halves Device Industry Fee in Revised Bill.
  • Risk Communication Committee Issues Recommendations.
  • Digital Mammography 510(k)s May Require Clinical Data.
  • Court Upholds Civil Money Penalty for Failure to Report MDRs. 
  • Transparency Task Force to Address Industry Concerns.
  • Supreme Court Considering Cases Affecting Diagnostic Test Patents. 
  • Task Force Debates Release of Information on Unapproved Products.
  • FDA Publishes Guidance on Emergency Use of H1N1 Diagnostics.
  • Lawsuit Continues Over Patenting of Breast Cancer Genes. 
  • National Registry, UDI System Proposed in Health Reform. 
  • FDA to Close Loophole for Study Investigators. 
  • House Health Reform Bill Reduces Device Tax.

OCTOBER 2009 MONTHLY TOPIC:
New FDA Leadership Focuses on Regulation and Enforcement

OCTOBER 2009 ISSUE:

  • FDA Looking at Clinicaltrials.gov Compliance.
  • Participants in UDI Pilot Concerned About Feasibility.
  • FDA Issues New CAD Guidance.
  • Shuren Seeking to Lead CDRH Permanently.
  • Committee Calls for More Oversight of Genetic Tests. 
  • Compliance Monitoring Likely on the Upswing at FDA. 
  • Industry Group Refuses to Support Reduced Health Reform Fee. 
  • FDA Calls for Postmarket Data on Spinal Devices.
  • OIG to Investigate FDA Consumer Complaint Process.
  • Amendments to Repeal Device Industry Fee Fail.
  • FDA to Take Task Force’s Advice.
  • FDA Adopts Risk Communication Plan.

SEPTEMBER 2009 MONTHLY TOPIC:
Senate Bill Proposes Funding Health Reform In Part by $40 Billion Fee on the Device Industry

SEPTEMBER 2009 ISSUE:

  • FDA Commissions IOM Review of 510(k) Program.
  • Health Reform Bills Address Physician Payments.
  • FDA Issues Good Manufacturing Practices for Combination Products.
  • New Combination Product Rules Expected Soon.
  • New Guidance Issued for AFib Device Trials. 
  • FDA to Hold Public Meeting on Internet Advertising.
  • Health Reform Bill May Charge Device Industry $4 Billion.
  • Industry Lauds Harkin’s Takeover of Committee.
  • Use of Registries Could Ease Post-Approval Study Burden.
  • Comments on Transparency Task Force Abound.
  • Health Technology Could Bolster Economy. 
  • Industry Concerned about Quality Measures and Reimbursement. 

AUGUST 2009 MONTHLY TOPIC:
Public Reporting of Adverse Events in Device Trials Goes into Effect on September 27, 2009,
Under Default Provisions of FDAAA

AUGUST 2009 ISSUE:

  • Industry Asks for Device-Specific Advertising Guidance.
  • FDA to Require More “522” Post-Approval Studies. 
  • FDA Guidance Aims to Increase Third-Party Inspections. 
  • FDA Proposes Electronic Adverse Event Reporting.
  • CMS Questions Quality of Lab-Developed Tests. 
  • Assays, Masks Under Scrutiny as Flu Season Approaches. 
  • FDA Device Center Director Resigns. 
  • Review of Preamendments Data Begins.
  • Industry Asks Supreme Court to Protect Patents for Diagnostics. 
  • Senators Spar on Preemption for Devices. 
  • Warning Letters to Come Faster, Hamburg Says. 
  • Comparative Effectiveness Budget Plans Detailed. 
  • Rapid Diagnostic Tests Could Reduce Hospital Infections. 
  • Experts Urge Caution in Informal Dialogue with FDA. 
  • Editorial Cites Challenges Facing Sentinel System.

JULY 2009 MONTHLY TOPIC:
Congress, GAO, Commissioner Emphasize Stricter Enforcement of Medical Device Regulations

JULY 2009 ISSUE:

  • FDA Promises More Aggressive Regulation of In Vitro Diagnostics.
  • FDA Unable to Determine its Funding Needs. 
  • FDA Advises Device Companies on Corrective Actions. 
  • Health Reform Could Include Device Registry.
  • Massachusetts Code of Conduct Takes Effect. 
  • Device Firms Concerned Health Reform Could Stifle Innovation.
  • Lawsuits Lodged Against Cardiac Device Companies. 
  • Commissioner Seeks to Restructure FDA Front Office.
  • AdvaMed Urges CMS to Reimburse for Devices Aimed at Infection. 
  • 510(k) Modification Policy Under Fire.
  • Device Firms May be More Vulnerable to Lawsuits.
  • Senate Pain Bill May Benefit Device Companies. 

JUNE 2009 MONTHLY TOPIC:
FDA Forms Transparency Task Force

JUNE 2009 ISSUE:

  • IOM Comparative Effectiveness Recommendations Could Impact Devices. 
  • FDA Guidance on Post-Approval Studies Forthcoming. 
  • Device Industry Urges Task Force to Protect Trade Secrets. 
  • Lawmakers Debate Legislative Changes to the 510(k) Process.
  • Panel Recommends Use of Bayesian Statistics to Support Coverage Decisions.
  • FDA, Industry Discuss Challenges to Universal Identifier System.
  • Kennedy’s Bill Concerns Device Industry. 
  • Health Reform Bills Address Comparative Effectiveness. 
  • Whistleblowers Should Air Grievances Internally First, Industry Says.
  • New Leaders Look to FDA’s Ability to Protect Public Health.
  • EU Medical Device Regulatory Overhaul on the Horizon.
  • Device Expenditures Represent Fraction of U.S. Health Spending.

MAY 2009 MONTHLY TOPIC:
FDA Attempts to Guide Industry on Device Advertising

MAY 2009 ISSUE:

  • Obama Memo Seems to Reject Preemption.
  • New FDA Leaders Will Look Into 510(k) Process.
  • Vermont May Institute Device Firm Disclosure Rules.
  • FDA Performs Internal Review of a 510(k) Clearance. 
  • CMS Refuses to Cover CT Colonography. 
  • Office of Health Reform Leaders Appointed.
  • Obama Requests Budget Increase for FDA Device Center.
  • FDA Revising Training Program for Device Reviewers.
  • Hamburg Outlines Goals, Discusses Device Reviews at Confirmation Hearing. 
  • Swine Flu Prompts Rush for Effective Diagnostic Tests.
  • Device Reps Should Have More Access to Doctors, IOM Says.
  • FDA Drafting QSR Guidance for Clinical Labs.
  • FDA’s New Risk Communication Plan Should Involve Industry.

APRIL 2009 MONTHLY TOPIC:
FDA and Industry Push to Reclassify Certain Devices

APRIL 2009 ISSUE:

  • Congress Seeks Review of Device Approval Process. 
  • Warning Letters Likely for Violations of ASR Regulation.
  • Device Firms to Publicly Report Adverse Events.
  • Intended Use Renders Software Medical Device.
  • Sebelius Answers Senators’ Additional Questions.
  • Competitive Bidding Rule for Certain Devices Takes Effect.  
  • Device Groups Seek to Preserve Preemption. 
  • FDA Requests Data on 25 Pre-Amendments Device Types. 
  • UDIs May Influence Reimbursement Policies.
  • FDA Requests International Joint Replacement Data.
  • Whistleblower Letters Released.
  • Consumers Urge Congress to Allow Device Suits.
  • AdvaMed Creates Plan for IVDs and LDTs.

MARCH 2009 MONTHLY TOPIC:
Supreme Court Ruling Drives Legislators to Challenge Preemption for Medical Devices

MARCH 2009 ISSUE:

  • IRBs Standards Raised at Congressional Hearing.
  • Electronic Medical Records as Medical Devices?
  • FDA/Sponsors Investigate Preclinical Testing for Heart Valves.
  • Industry, FDA Staff Optimistic About New Leadership
  • FDA Memo Urges Confidentiality
  • Chief Counsel Review of QSR Warning Letters May Cease
  • Obama Appoints Hamburg FDA Commissioner
  • Reviewers Continue to Clash with FDA Supervisors over 510(k)s
  • CDRH Issues Guidance Regarding PMA Fees
  • AdvaMed Releases Guidelines for DTC Ads
  • Device Industry Not Likely to be Hard-Hit by Obama Budget
  • FDA, NIH to Address Pediatric Devices
  • FDA Funding on the Rise
  • FDA Increasing its Focus on Science
  • Budget Proposes Pre-authorization for Imaging Services

FEBRUARY 2009 MONTHLY TOPIC:
FDA Working to Devise Unique Identifier System for Devices

FEBRUARY 2009 ISSUE:

  • Comparative Effectiveness Research Made Into Law.
  • Industry Awaits Combination Products Regulations and Guidance
  • Sponsors Requesting Add-On Payments Look for FDA Approvals
  • Comparative Effectiveness Research Bill Passes
  • Sunshine Act Revised to Prevent Duplication
  • FDA to Require More Oversight of Suppliers
  • FDA Unique Identifiers Should Address Risky Products First
  • Administration Official Weighs in on Cost-Effectiveness Research
  • Daschle’s Withdrawal May Have Far-Reaching Effects
  • HHS Guidance Leaves Questions Unanswered
  • FDA Device Staff Refute Whistleblowers’ Claims
  • Device Industry Hopes for Senate Version of Stimulus Bill
  • Globalization Act Addresses Oversight of Foreign Device Manufacturers

JANUARY 2009 MONTHLY TOPIC:
Long-Awaited GAO Report Urges Action on Preamendments Devices

JANUARY 2009 ISSUE:

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