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Browse English Issue Headlines - November 2010

Risk Management and Post-Market Surveillance: FDA Considerations

The 3rd edition of IEC 60601-1 continues to move towards formal adoption by regulators around the world. As a result, many manufacturers are working towards implementation of processes in compliance with the requirements of ISO 14971 for risk management, as required by the 3rd edition of IEC 60601-1. However, some certification schemes do not assess all elements of ISO 14971, (e.g. requirements for post-market surveillance) and some regulators, notably the US Food and Drug Administration, have yet to issue formal guidance on what will be necessary for compliance. This leaves the prudent regulatory manager in a quandary: will a certification that has assessed only parts of ISO 14971 satisfy all regulatory agencies? Will a full implementation of ISO 14971 be a better choice? Mark Leimbeck and Larry Kessler review the current FDA regulations related to risk management and post-market surveillance to provide additional context when considering these questions. More >>

Revision of ISO 14155 on Clinical Investigations of Medical Devices

A final draft of a new version of the standard ISO 14155, Clinical investigations of medical devices for human subjects – Good clinical practices was published on 14 June 2010 for comment. Professor Dr Klaus Dermann Chairman of CEN/TC 258, reviews the changes introduced by the new standard. More >>

Application of Requirements for Medical Devices Containing Phthalates Introduced by Directive 2007/47/EC

European Directive 2007/47/EC introduced obligations requiring devices that possibly release phthalates belonging to category 1 or 2 (in accordance with Annex I to Directive 67/548/EEC, as amended) into the body of the patient to be labelled accordingly. Haroon Atchia's examines the requirements introduced by Directive 2007/47/EC and the actions that must be taken to comply with the requirements. More >>

US Medical Device Software Regulation

For more than two decades, the US Center for Devices and Radiological Health has regarded software as needing special regulatory attention. This article by Sherman Eagles and Alan Kusinitz focuses on software that is regulated as a medical device. The authors summarise the regulatory requirements for software, as well as the safety and efficacy requirements for pre-market submissions, before considering the Food and Drug Administration’s use of industry standards, and how to determine compliance to the requirements. The authors also compare and contrast the regulatory requirements for software in the USA and the European Union. More >>

European Update

  • Status of Tampons Containing Lactic Acid-Producing Bacteria
  • IVD Directive: Commission Solicits Comments on vCJD Assays
  • Commission Addresses Key Issues in Medical Radiation
  • Commission Releases Report on Reprocessing of Medical Devices
  • Competent Authorities for Medical Devices Meeting
  • Joint Scientific Committee WG on New Challenges for Risk Assessment
  • CIE Reviews Draft Guidance on SAE Reporting
  • Ireland Publishes Revised Guidance Documents
  • IMB Safety Notice on Effective Traceability of Medical Devices
  • IMB Safety Notice: Cleaning and Decontamination of Reusable Devices
  • Italy Trials Simplified Licensing Process for Healthcare Advertising
  • Spanish Information Notice on Aesthetic Devices
  • UK MHRA Relocates
  • UK Department of Health Plans to Cut Bureaucracy
  • Medical Device Register accessible via UK MHRA website
  • Medical Device Alerts issued by UK MHRA
  • NICE Consultation on its Evaluation Pathway Programme

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US Update

  • Medical Device User Fees for FY 2011
  • Obama Signs Tariffs Bill to Aid Manufacturers
  • Radiation Protection Bill to Come into Effect in July 2012
  • FDA Performance Management System launched
  • ODE Annual Review Issued
  • Funding for Clinical Studies on Products for Rare Diseases
  • Reclassification of Certain PTCA Catheters
  • Pre-Market Approval for Four Pre-Amendments Devices
  • CDRH: 510(k)s and Science in Regulatory Decision-Making
  • CDRH Inspections Database
  • CDRH to Enhance Advertising Enforcement Initiatives
  • Parallel Review of Medical Products by FDA and CMS Proposed
  • Comprehensive List of Guidance Documents
  • FY 2011 CDRH Proposed Guidance Developments
  • HSV Assays: Reclassification and Draft Guidance on Class II Special Controls
  • Guidance on Addition of URLs to Electronic Product Labelling
  • Guidance on Animal Studies for Cardiovascular Devices
  • Question & Answer Guidance on Impact-Resistant Lenses
  • Guidance on Devices Used to Treat BPH
  • Guidance on Labelling of Contact Lens Care Products
  • Draft Guidance on IVDs for the Detection of Helicobacter pylori
  • 510(k)s for Lamotrigine & Zonisamide Assays: Draft Guidance
  • Neurological and Physical Medicine Devices: Comment Period Extended
  • Regulation of Laboratory Developed Tests: Comment Period Extended
  • Safety Alerts from the FDA
  • FDA Risk Communication Advisory Committee Meeting
  • Gastroenterology and Urology Devices Panel Meeting Notice
  • Support of Use of Symbols in Labelling of IVDs: Comment Period
  • Third-Party Review under the FDAMA
  • Cooperative Agreement with PAHO under Consideration

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International Update

  • IVD Guidance Documents Being Developed in Australia
  • Canadian Guidance on the Medical Device Inspection Program
  • Draft Guidance on STED-based Class III and Class IV Applications in Canada
  • HIV Test Kits for Laboratory Use: Draft Revisions to Canadian Guidance
  • Health Canada to Issue e-Labelling Notice
  • China hosts the International Medical Device Regulatory Forum
  • Colombia: Registration Requirements Affecting Diagnostic Kits & Reagents
  • GHTF Documents
  • GMDN: Commission Support and FDA Recommendations
  • Comments Sought on Proposed Hong Kong Regulatory Framework
  • India Publishes Four Guidance Documents for Comment
  • Reclassification in Japan Results in 120 Additional Class 2 Devices
  • Pre-review System for Device Applications Requiring Clinical Data in Japan
  • Reimbursement Updates in Japan
  • Proposed Revision of Device Classification in Korea
  • New Zealand to Update Recall Procedures for Medicines & Devices
  • Peru: Supreme Decree Regulates Law on Medical Products
  • Regulatory Control of Medical Devices is Implemented in Singapore
  • WHO Outcome of the Priority Medical Devices Project

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Environment Update

  • Requirements for Chemicals in Europe: Deadlines Imminent
  • European Consortium Submission for DEHP under REACH

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Standards Update

  • Modifications to the List of US FDA-Recognised Standards
  • US FDA Formally Recognises AAMI Version of IEC 60601-1/Ed.3
  • AAMI Standards on Dialysis Products and Blood Circuits Adopted
  • Safety Priorities for Infusion Pumps released by AAMI
  • CEN standards: Closures for Injection Vials and Nanotechnologies
  • ISO Standard on Tests for Irritation and Skin-Sensitisation

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Reference Information

  • Regulatory personnel on the move
  • Country focus: Switzerland
  • Elemental essentials: CLIA

More >>