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Journal of Medical Device Regulation Issue Headlines - May 2008

US Office of Device Evaluation – Current Trends and Future Directions

In this Editorial, Dr Donna-Bea Tillman, Director of the Office of Device Evaluation (ODE) at the US Food and Drug Administration talks to the Journal of Medical Device Regulation about some of the current challenges facing the ODE. She also discusses the role that the medical device industry can play in helping the Agency to meet its targets and overcome its challenges. More >>

Requirements in Directive 93/42/EEC for Custom-Made Medical Devices and Systems and Procedure Packs

Haroon Atchia examines the requirements imposed on manufacturers of custom-made medical devices and manufacturers of systems and procedure packs by Directive 93/42/EEC. The article also looks at how a manufacturer may demonstrate control of principal sub-contractors (e.g. for sterilisation) plus regulatory issues arising from various labelling statements. The influence on conformity assessment for the CE mark is explored, taking into account the design, construction, typical configuration, intended purpose and market requirements for such devices. The relevant provisions of the Directive are appraised critically, in context with the principles of best practice and the doctrine of duty-of-care. This appraisal identifies the necessary compliance elements from legal, regulatory and technical perspectives. Conflicting or contradictory elements are illustrated, enabling a clear understanding of what is intended by the controls given in the Directive. The roles, responsibilities and authorities of the principal regulatory authorities involved in the conformity assessment process are clarified, distinguishing elements relating to quality management systems registration assessment and others relating to obligations strictly concerned with the Directive. More >>

Resolving Disputes with your US FDA Review Team

Dispute resolution is a very formal term for the mechanisms available to sponsors when they have been unable to resolve a difference of opinion with their Food and Drug Administration (FDA) counterparts on a specific submission. However, this is really a much more flexible and customised process than the term might imply. In this article, Elisa D Harvey provides helpful information for sponsors on how to go about solving the problem of a difference of opinion with an FDA review team, including her top 10 tips for resolving disputes. More >>

An Overview of Medical Device Regulations in Latin America

Brazil was the first country to implement any form of control over healthcare products back in 1976 and its current legislation, which was issued in the 1990s, has been used as the model for legislation implemented in the other countries in the Southern Common Market (Mercosur). The Mercosur legislation has subsequently been used as the standard for several other Latin American countries, except for Mexico’s, which follows that of the USA. Many of the Latin American countries now have structured regulatory systems for medical devices and in vitro diagnostics, and Panama and Costa Rica are planning to introduce systems during 2009. Victoria Clark’s article explores the similarities of the various Latin American regulatory systems for medical devices by looking at the systems in place for company approvals, product registrations, quality systems, labelling and language requirements, and after-sales care. More >>

European Update

  • Denmark creates register of human tissue establishments
  • Consolidated versions of 90/385/EEC and 93/42/EEC issued
  • Electromedical equipment used in veterinary medicine
  • Commission issues three interpretive documents
  • Updated MEDDEV on TSE risk from animal tissues
  • New manual on borderline and classification issues
  • Draft Commission guideline on clinical evaluation of coronary stents
  • Pilot programme for implementation of Directive 2007/47/EC
  • Concerns still exist over safety of DEHP used in medical devices
  • Commission adopts code of conduct for nanotechnology
  • 21st Competent Authorities’ meeting report
  • NBOG meeting report
  • European Commission does not issue Certificates of Free Sale
  • Finland’s NAM updates its strategy for 2008-2012
  • Procedures for obtaining Certificates of Free Sale in France
  • Classification and positioning of devices and IVDs in France
  • Adverse event reports for cellular and tissue-based products
  • German device industry calls for changes to innovation clause
  • German health insurance funding
  • Irish guidelines for Ethics Committees on clinical investigations
  • Portugal clarifies use of latex free symbol on product labelling
  • Contact with Swissmedic
  • Swiss devices affected by chemicals legislation
  • Vigilance reporting in the UK
  • UK Medical Device Alerts
  • Reporting adverse incidents and disseminating device alerts
  • NICE appraisal of drug-eluting stents
  • NICE consults on clinical guideline development process

More >>

US Update

  • FDA’s fiscal year 2009 budget request
  • Challenges for FDA in conducting manufacturer inspections
  • Draft Medical Device Safety Act of 2008
  • Reclassification of medical device data systems
  • Guidance on integrity testing for sterile products
  • CLIA waiver applications for IVDs
  • Guidance for coronary and carotid embolic protection devices
  • Medical glove guidance manual
  • Updated guidance on interactive review for device submissions
  • Guidance on expedited review of premarket submissions
  • New software guidance available for manufacturers
  • Guidelines on drug-eluting stents proposed
  • Draft guidance on Good Reprint Practices published
  • Draft guidance on IVDs for detecting influenza viruses
  • Draft guidance on certifications to accompany product applications
  • Denture cleansers: public health notification
  • Potential impact of RFID on implantable devices to be investigated

More >>

International Update

  • Fees charged by ANMAT for CFS and clinical trials
  • Australia prepares regulatory guidelines for medical devices
  • Brazil proposes new registration system for product groups
  • New Brazilian post-market surveillance system proposed
  • Canadian guidance on adult hospital beds
  • China’s SFDA to fall under MoH as part of cabinet reshuffle
  • China proposes device recall procedures
  • SFDA conducts investigations of registered medical devices
  • Medical device experts to assist China’s SFDA
  • Other Chinese news updates
  • Colombia postpones device registration
  • India creates committee on price negotiations
  • ASEAN: industry association and proposed device directive
  • AHWP issues final documents on SADS
  • US FDA to establish presence in China
  • USA signs trade agreement with Ukraine
  • EU and Ukraine launch FTA negotiations
  • Association agreement between EU and Central America
  • CENELEC and COCIR sign updated cooperation agreement
  • GHTF documents
  • Changes to reimbursement of medical devices in Japan
  • Renewals of old product registrations in Mexico
  • Thailand’s new Medical Device Act approved
  • Ministerial Announcement published on tests for HIV infection
  • New level of control proposed for contact lenses in Thailand

More >>

Environment Update

  • WEEE, batteries, accumulators and RoHS Directives
  • Results of second consultation on Directive 2002/95/EC
  • Conflict arises over proposed mercury ban

More >>

Standards Update

  • Harmonised EU standards

More >>

Reference Information

  • Regulatory personnel on the move
  • Country overview: Israel
  • Elemental Essentials: FEA in medical product development
  • GHTF/SG2/N54R8:2006 – German translation (part 1)
  • Medical device reporting requirements

More >>