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Journal of Medical Device Regulation Issue Headlines - May 2009

Reviews and Reforms in Australia

Regulatory reform seems to be the phrase of the moment as each of the main Offices of the Australian Therapeutic Goods Administration (TGA) have been undertaking a range of reviews, culminating in industry consultations in late July/August 2008. Alongside the reforms in each of the Offices, some major updates of the electronic systems of the TGA business were implemented in November 2008. Jennifer Svec reviews these changes and also identifies areas still in need of attention. More >>

Enhancing the Introduction and the Safe Use of Medical Technology in Europe

The rapid introduction of new technology and ensuring its subsequent safe use lies at the very top of the agenda for the medical devices industry. Three major issues - telemedicine, rare diseases and patient safety – have been taken forward at European level by the Commission during the past six months. Dr David Jefferys takes a look at these initiatives, which he believes will greatly assist and support innovation within the medical technology sector. More >>

Off-Label Use of Medical Devices in the USA

It may be difficult for a European observer to grasp the intricacies of the ‘off label’ discussions in the USA because of the vastly different view as to what constitutes a medical device. The difference is more than language; it is cultural. The real difference is the patina of interpretation placed upon medical devices by the US Food and Drug Administration, which is more a case of tribal lore than predetermined statutory design. In this article, Robert J Klepinski explores the US legal situation for the off-label promotion of medical devices by examining a number of case studies, and offers advice to manufacturers on avoiding potential pitfalls. More >>

FDA’s Good Reprint Practices and Product Liability

The US Food and Drug Administration (FDA) recently finalised a guidance document entitled Good Reprint Practices for the Distribution of Medical Journal Articles and Medical Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices, which describes the conditions under which the FDA will allow drug and device companies to proactively disseminate certain off-label use information. Alan G Minsk examines the content of this guidance document and urges others to do the same, as dissemination of off-label information has the potential to affect product liability exposure. More >>

As Purchasing Controls Become an FDA Hot Topic, It’s Time to Assess How Well You Are Managing Your Suppliers

US Food and Drug Administration (FDA) scrutiny of device manufacturers’ compliance with the Purchasing Control and Acceptance Activity requirements of the Quality System Regulation (QSR) is on the rise. This article by Edward C Wilson, Jr and Michael S Heyl focuses on the Purchasing Control provisions of the FDA’s QSR; recent developments regarding enforcement of those requirements; international guidance aimed at helping manufacturers exercise appropriate control over third-party suppliers; and tips to ensure compliance with FDA’s Purchasing Control requirements. More >>

European Update

  • Denmark transposes Directive 2007/47/EC
  • Denmark updates fee charges for medical equipment
  • CTSs for IVDs in Europe are updated
  • SCENIHR adopts opinion on safety of nanotechnology
  • SCENIHR adopts position paper on role of the Committee
  • France repeals decision on aortic stents
  • Fourth amendment to German MPG proposed
  • Irish Medicines Board restructured
  • Ireland publishes guidance on systems and procedure packs
  • Fee charged for promotional activities relating to devices in Italy
  • Italy publishes guidance on Directory of Medical Devices
  • Products for general laboratory use in Portugal
  • Four-year strategic plan for Spain’s AEMPS published
  • Proposed revision of Swiss Ordinance on Medical Devices
  • UK MHRA requires re-registration by 31 May 2009
  • UK MHRA issues guidance on vigilance systems
  • Reporting adverse incidents and disseminating device alerts

More >>

US Update

  • FDA to review pre-amendment Class III devices
  • Omnibus Budget Act promises more funds for device activities
  • Guidance on hearing aids and personal sound amplification products
  • Guidance on 510(k) submissions for ANA test systems
  • Guidance on certifications to accompany device applications
  • Draft guidance on user fees and refunds for PMAs
  • Draft guidance on abbreviated laboratory packages
  • Draft guidance on IDEs for retinal prostheses
  • CDRH adverse event problem codes
  • Massachusetts passes new rules on sales and marketing
  • AdvaMed proposes changes to regulation of diagnostic tests
  • AdvaMed publishes best practices for DTC device advertising
  • Risk of wearing medicated patches during MRIs is highlighted

More >>

International Update

  • Amendments to the Australian Therapeutic Goods Act 1989
  • Australia publishes TGO No 82 on menstrual tampons
  • Australia hopes to introduce IVD regulatory framework in 2009
  • Australia continues consultation on regulatory guidelines
  • Australia’s health technology assessments to be reviewed
  • Bahrain drafts guide on Notified Bodies
  • Grouping of orthopaedic implants for registration at ANVISA
  • Brazil drafts resolution on PMS of health products
  • Two Canadian medical technology associations merge
  • Devices with electrical components sold in Ontario, Canada
  • Chinese news updates
  • Hong Kong proposes listing Class B, C and D IVDs
  • India clarifies regulatory control for certain devices
  • Indian device companies form industry association
  • GHTF documents
  • Increases in Japan’s medical device review fees
  • Restructuring of the Korean Food and Drug Administration
  • Kuwait drafts guide on Notified Bodies
  • New Zealand issues safety alert on infusion device software
  • Saudi Arabia drafts guide on Notified Bodies
  • Saudi Arabia drafts General Product Safety Regulations
  • Tanzania begins to introduce regulatory controls for devices
  • Certain regulatory powers move to provincial Thai governments
  • Thailand increases liability for device manufacturers
  • Vietnam requires clinical trials for first-time device imports

More >>

Environment Update

  • Proposed recast of WEEE and RoHS Directives
  • Chemicals classification, labelling and packaging
  • Amendment of REACH Regulation
  • Ukraine aligns requirements with European RoHS Directive

More >>

Standards Update

  • Three Chinese standards released for comment
  • Harmonised EU standards
  • Proposed revision of two Israeli standards
  • Mandatory Mexican standard for control and distribution equipment
  • Modifications to the list of US FDA recognised standards

More >>

Reference Information

  • Regulatory personnel on the move
  • Country overview: Uruguay
  • Elemental Essentials: Globally Harmonized System of Classification and Labelling of Chemicals (GHS)
  • Book review: Combination Products; Regulatory Challenges and Successful Product Development
  • Interview with Dr Sandeep Shah

More >>