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Browse English Issue Headlines - February 2005

CDRH Third Party Review Program

Unlike the premarket authorisation process for new medical devices in the EU, where manufacturers/sponsors submit their technical files or design dossiers to Notified Bodies, the US Office of Device Evaluation of the Food and Drug Administration's (FDA's) Center for Devices and Radiological Health (CDRH), has until recently been the sole reviewer of all premarket applications including applications for Investigational Device Exemption, premarket notifications and premarket approval applications. Eventually, the large number applications processed annually resulted in progressively longer review times and application backlogs. In 1996, CDRH initiated a pilot program that authorised non-FDA third party entities to conduct selected premarket reviews. A second third party review program was added later. Both programs are voluntary and the manufacturer/sponsor of the premarket application continues to have the option to submit the premarket notification directly to the FDA, even for those devices eligible for third party review.

In this article, Rosina Robinson looks at the Third Party Review Program from the perspective of the medical device manufacturer/sponsor of the premarket notification, and does not address the requirements for and procedures followed for the accreditation of the third party or the requirements for maintaining third party status. Many of the references referred to in this article include descriptions of these requirements. More >>

Moving towards an IT-based risk management system

Amidst the most obvious manifestations of the increasing consumerisation of medicine, regulatory agencies are acknowledging the limitations of the traditional risk management methods and tools in the commercial deployment of medical devices and pharmaceuticals. In this article, Terry Knapp addresses specific elements of the FDA Concept Paper entitled Risk Management Programs, and comments on the manner in which modern IT-based solutions can assist manufacturers, doctors, pharmacists and patients to derive maximum benefit coupled with lowest risk in the use of pharmaceuticals, biologicals and medical devices. More >>

Clinical data in the EU

The regulations for placement of medical devices on the market in the EU are prescribed in the various EC Directives but are not well defined. Concentrating on Council Directive 93/42/EEC (commonly known as the Medical Device Directive, MDD), Haroon Atchia explains the requirements, distinguishes the various options available for demonstrating clinical utility of a given medical device, and explores the role of the Competent Authority in dealing with applications for commencement of a clinical investigation for the purposes of CE marking. More >>

Positioning medical devices when reimbursement is not an option (2)

A technology's prospects for 'reimbursement' refers to three interrelated processes: its prospects for insurance coverage, the billing and procedure codes assigned to it and the actual payment, if any, it will generate when used. In most instances the procedures using the technology, and not the technology itself, generate reimbursement. Consequently, the price of the technology can become a major barrier to product adoption unless additional payment is built into the procedure reimbursement or the purchaser becomes convinced that the technology brings clinical and economic value that is not tied to the procedure reimbursement itself. Manufacturers need to quantify technology ‘value' in ways that are meaningful to purchasers and users in order to successfully position medical devices.

In Part 1 of this article, which was published in the November 2004 issue, Nancy L Reaven gave examples of some of the most common reasons why reimbursement is not available for medical technologies in the US and discussed strategies for overcoming resulting barriers to product adoption. The concluding part of the article focuses on the financial incentives and perspectives motivating technology purchasers and suggests various approaches to relevant 'value' analyses. More >>

European Update

  • Denmark's authorisation scheme for human tissues and cells
  • MDD revisions
  • Devices utilising animal tissues
  • Electromagnetic compatibility Directive
  • Data protection
  • Mammography equipment in France
  • In vitro diagnostics: new French regulations
  • Germany's second DRG amendment law compromise
  • Irish guidance on adverse incident reporting for IVDs
  • Devices containing tissue of animal origin in Portugal
  • Payments to Slovak Republic's SÚKL
  • Swiss information on use of high energy lasers
  • Guidance on medical weighing machines issued in Switzerland
  • Medical Device Alerts issued by UK MHRA
  • UK Healthcare Industries Task Force

More >>

US Update

  • Reclassification of two embolisation devices
  • External penile rigidity devices: classification
  • Assisted reproduction laser systems: classification
  • Clinical chemistry and clinical toxicology devices: classification
  • General hospital and personal use devices: classification
  • Withdrawn proposed rules
  • HDEs, special controls and environmental assessment exclusions
  • Reclassification of iontophoresis devices
  • Reprocessed single-use devices
  • MDTCA/MDUFMA summaries available
  • Summaries of final FDA guidance documents issued

More >>


  • Goods that are not medical devices in Australia
  • Tamper-evident packaging
  • Diagnostic goods of human origin
  • Australia's prostheses reimbursement scheme
  • Australian classification guidelines published
  • Draft TGA fact sheets issued
  • Private label devices: draft Canadian guidance
  • SBD and ND documents for devices marketed in Canada
  • Health Canada's safety advice on electrically operated beds
  • Antimicrobial agents used on devices in Canada
  • Chinese device news
  • Hong Kong's Medical Device Administrative Control System
  • Free Trade Agreements
  • Kazakhstan joins IEC
  • EC/US MRA on electromagnetic compatibility
  • Japan publishes draft regulations for IVDs
  • Low risk medical devices in Japan - third party certification
  • Japan's rules for marketing authorisation holders
  • Thailand's Medical Device Bill
  • Thai FDA's one stop service centre
  • Quality system documentation in Thailand
  • Other news from the Thai FDA

More >>

Environment Update

  • Packaging and packaging waste
  • Electrical and electronic equipment
  • Batteries and accumulators

More >>

Standards Update

  • ISO/TR 14969: 2004
  • ISO 14155 on clinical investigations
  • Nanotechnology standardisation recommendations issued
  • Digital imaging and communications in medicine

More >>

Reference Information

  • Meeting report: Is technology convergence the future of medical devices?
  • Elemental Essentials: Harmonised standards
  • New Approach Regulations - Part 2
  • Country Overview: China

More >>