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Journal of Medical Device Regulation Issue Headlines - August 2008

Journal of Medical Device Regulation Interview

Sinisa Tomic, Director of the Croatian Agency for Medicinal Products and Medical Devices talks exclusively to Marija Capek. More >>

Future Revision of the European Medical Devices Directives

In May 2008, the European Commission launched a public consultation on its proposals for recasting (in a Regulation) Directive 90/385/EEC (on implantable medical devices), Directive 93/42/EEC (general framework) and Directives 2000/70/EC and 2001/104/EC (on blood derivatives). Dr David Jefferys examines the details of this questionnaire, which he believes clearly reveal the current thinking within the Commission. More >>

The Ethics of Offshoring Clinical Trials

A recent newspaper article by Andrew Jack entitled New lease on life? The ethics of offshoring clinical trials publicised concerns over the exploitation of participants in clinical investigations in human subjects by Western pharmaceutical companies. Haroon Atchia considers these concerns, which ranged from violations in communicating informed consent to withholding comparison of the proposed new treatment to the best approved existing medicine available in the West. More >>

An Analysis of the Reasons and Merits for FDA PMA Disapproval

For the purposes of comparing the merits of the European CE marking and the US Pre-Market Approval (PMA) regulatory processes for medical devices, this article by Ralph Jugo is devoted to describing and analysing the reasons why, historically, PMA applications in the USA have been found to be not approvable by the Food and Drug Administration (FDA) for Class III medical devices. The research found that from December 2002 through to the time that the research was conducted in 2007, there were seven PMA applications that were disapproved by the FDA based in part on disapproval recommendations by the FDA appointed scientific Advisory Panels. Of these seven PMA applications, five of the devices were found to have received prior European CE marking. An analysis of the reasons given by the FDA and the Advisory Panels for PMA disapproval led to the conclusion that the disapprovals did not appear warranted in the majority of the cases. In further efforts to compare the EU and US regulatory systems, a preliminary post-CE mark approval examination of safety-related problems was performed. This examination revealed that no safety-related problems had been reported in France, Germany or the UK for the five devices that had received CE mark approval but PMA disapproval. This preliminary finding supports the potential superiority of the European system because, based on prior research, EU CE mark approval versus US PMA occurs sooner, and the EU system permitted the approval of devices which were disapproved in the US but once marketed in the EU these devices did not have any reported safety problems which could have warranted their disapproval. More >>

A Centralised Dispute Resolution Procedure for Borderline and Classification Matters

The aim of this article by Dr Sharon Frank is to analyse issues in the pre-marketing phase of medical devices, notably when defining a product as a medical device (c.f. borderline products), the classification of medical devices (categorisation of devices in accordance with their risk), and the role of Notified Bodies in these two issues. The primary focus is on whether decision-making procedures, in the case of divergent opinions relating to borderline products and classification of medical devices, can be improved by the creation of a centralised dispute resolution procedure. The rationale for proposing an agency is derived from the conclusions that the current functioning of the executive regime for medical devices lacks a clear legislative mandate, accountability, transparency, consistency, participation of interested parties, and the use of formal procedures. More >>

Medical Device Reimbursement in the USA

Securing reimbursement for medical devices in the USA can be challenging, especially for those who are unfamiliar with the process. This article by Barb Peterson explains the basic reimbursement concepts of coding, coverage and payment, and then reviews how best to achieve positive reimbursement for a product. More >>

European Update

  • European Council adopts rules to amend New Approach system
  • Safety of dental amalgams
  • SCHER: use of non-human primates in biomedical research
  • Manual on borderline and classification issues updated
  • European Chemicals Agency officially opened
  • Test methods published for REACH
  • EDPS opinion on use of RFID in Europe
  • Consultation findings on reprocessing of medical devices
  • NBOG meeting report
  • German DRGs
  • Overview of Italian device registration requirements
  • UK holds consultation on transposition of Directive 2007/47/EC
  • UK guidance on vigilance for joint replacement implants
  • UK guidance on medical lasers and optical radiation devices
  • General Medical Device Alerts in the UK

More >>

US Update

  • Senate Appropriations Committee votes to increase funding
  • Classification of Plasmodium species antigen detection assays
  • Reclassification of bone sonometers
  • Reclassification of topical-use tissue adhesives
  • Removal of baseline reports from reporting requirements
  • Proposed reclassification of FFDM radiology devices
  • Recommendation for reclassification of PTCA catheters
  • Comments sought on registry of breast cancer treatment
  • Technical amendments to medical device regulations
  • Technical amendments to hearing aid regulations
  • Final guidance documents
  • Senate passes Medicare Act
  • FDA panel recommends stricter contact lens labelling

More >>

International Update

  • Australian TGA fees and charges for 2008/9
  • Excluded therapeutic goods in Australia
  • Australian MDSOs and CASOs
  • Australia continues consultation on ARGMD
  • Draft report on Australia’s regulatory burdens affecting devices
  • Relaxed Brazilian requirements for export-only devices
  • Canada requires identification of DEHP/BPA-containing devices
  • China drafts enhanced medical device registration requirements
  • Chinese public consultation concerning IVD reagents
  • Consultation on Chinese GMP regulation and guidance
  • SFDA classifies 43 medical products
  • China releases list of 73 approved industry standards
  • Hong Kong streamlines listing process
  • Update on Hong Kong’s proposed regulatory framework
  • Concerns about crossover of medical device Bills in India
  • Regulatory concerns for devices highlighted at China/US meeting
  • Singapore signs MoU with Switzerland
  • USA signs agreements with South and East African communities
  • USA and Vietnam sign MoU on medical product safety
  • GHTF documents
  • Study reveals potential hazards of RFID on medical devices
  • Korea proposes amendments to its medical device regulations
  • Summary: adverse event reporting in Paraguay
  • Saudi Arabia joins NCAR programme
  • South Africa drafts legislation affecting healthcare products
  • Thailand’s Medical Device Act implemented
  • Other Thai news
  • Use of unique identification number for devices in Turkey

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Standards Update

  • EN 980: 2008 on graphical symbols published
  • Implementation of new electrical equipment standard in China

More >>

Reference Information

  • Regulatory personnel on the move
  • Country overview: Brazil
  • Elemental Essentials: investigational device exemptions
  • Book review: Pharmaceutical and Medical Device Validation by Experimental Design
  • NB-MED Recommendations

More >>