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Browse English Issue Headlines - November 2007

Requirements for a Modified Approach to Clinical Data

The requirements for the clinical data to support a medical device have always been the subject of debate and some controversy. The legislative requirements are quite clear but there are a range of false perceptions. The revision of the European Medical Device Directive (93/42/EEC) and the work of Study Group 5 of the Global Harmonisation Task Force have considerably advanced the important topic of clinical support and evaluation of medical devices. According to Dr David Jefferys, the remaining ambiguities and uncertainties can best be addressed by discussions with the Notified Bodies and Competent Authorities, and also by the use of independent external experts who can critically analyse projects and help to reach decisions as to when clinical data are necessary or when a company can rely solely on bench-top or historical literature data. More >>

The FDA PMA Filing and Approval Experience: An Empirical and Descriptive Analysis

Ralph Jugo’s article is devoted to performing a descriptive and statistical analysis of the US Food and Drug Administration (FDA) premarket approval application (PMA) process, which is the regulatory pathway for the introduction of Class III medical devices into commercial distribution in the USA. Based on information contained in the FDA PMA database located on the FDA website, all available information on PMA applications from the years 2003 through 2007 inclusive were examined. Data on 42 PMA applications were generated and revealed that, in light of the observed results and despite the fact that the FDA’s ability to adjust the clock cannot be accounted for, the PMA approval process appears to take too long, and is overly cumbersome. A recommendation is made to bring the major stakeholders together to address ways of resolving this issue, which can delay the introduction of innovative new medical devices into commercial distribution. In the end, the ultimate beneficiaries of this effort will be patients. More >>

Rationale Behind the Principal Changes to and Inclusion of New Elements in the Requirements of EN ISO 11137: 2006/7

The preparation of standards for the validation and routine control of sterilisation of medical devices by irradiation (EN 552: 1994 and ISO 11137: 1995) started in 1989. The standards are technically equivalent and entirely compatible, but they are editorially different, adding complexity for manufacturers and radiation processors who need to comply with both the European and US requirements. In 1999, the review and revision of the radiation sterilisation standard was undertaken in parallel with those of the standards for development, validation and routine control of the sterilisation methods employing ethylene oxide and moist heat. As review and revision progressed, it became obvious that management of the application of the standard would best be satisfied if its content was divided. Accordingly, three parts were prepared, under the title EN ISO 11137: 2006/7, Sterilization of health care products – Radiation. The purpose of this article by Eamonn V Hoxey and Alan Tallentire is to document the rationale behind the principal changes that have been incorporated into the requirements specified in the revised standard. A record of this type will, it is anticipated, assist users of the standard to understand why changes were made, as well as comprising an aide memoire for others who, in the future, could be faced with further revision activities. More >>

You Have Met with The FDA - Now What?

This second article by Elisa D Harvey focuses on what to do once you have had an initial interaction, such as a face-to-face meeting, with the US Food and Drug Administration (FDA). Once you have already spent a lot of time preparing, doing your homework, producing a quality pre-IDE submission, planning and rehearsing a quality presentation and providing specific focused questions, then finally actually had the meeting, what happens next? You have doubtless received a lot of information from the FDA team that attended the meeting that you now need to digest and determine how to respond. This article examines the various things that can, or should, occur during and especially after a meeting with the FDA, and how to react to ensure your project continues to move forward. More >>

European Update

  • Bulgaria publishes new device law
  • Revisions to MDD published
  • Electromedical equipment used in veterinary medicine
  • Proposal to suspend metric-only labelling Directive
  • Safety of medical devices containing DEHP
  • Questionnaire on vCJD diagnostic assays
  • Court of Justice case on implementation of Directive 93/42/EEC
  • French National Medical Devices Commission established
  • Technical summaries required from French manufacturers
  • French internal quality controls for external radiotherapy installations
  • German classification guideline adopted
  • Safety recommendations on x-ray systems issued by BfArM
  • Safety of devices used in the community setting in Ireland
  • Italian device registration requirements
  • Transfer of responsibilities for AIMDs in Portugal
  • Spain transposes Directive 2005/50/EC
  • MHRA’s proposed regulatory fees from 1 April 2008
  • UK NICE proposes reimbursement ban for drug-eluting stents

More >>

US Update

  • Update on the Medical Device User Fee Programme
  • General and plastic surgery devices: classification
  • Classification of in vitro HIV drug resistance genotype assay
  • Classification of remote medication management systems
  • Proposed classification of electrocardiograph electrodes
  • Guidance on small business qualification for 2008 user fees
  • Guidance on 510(k)s for biological indicators
  • Guidance on commercially-distributed ASRs
  • Guidance on faecal occult blood tests
  • Guidance on procedures for handling post-approval studies
  • Guidance on writing ‘Dear Doctor’ letters for recalls of ICDs
  • Guidance on regulatory compliance of cabinet x-ray systems
  • Guidance affecting certain laser light show variances
  • Guidance on non-clinical information for femoral stem prostheses
  • Guidance on exports
  • Guidance on emergency use of medical products
  • Draft guidance on IVDMIAs
  • 2008 proposed guidance development
  • Ban on use of live animals for marketing devices

More >>

International Update

  • Brazil postpones restrictions on the re-use of medical devices
  • Brazil proposes amendments to orthopaedic implant registration
  • Health Canada proposes changes to investigational testing
  • China announces stricter regulations for devices
  • Hong Kong to conduct regulatory impact assessment
  • Further guidance for import registration and manufacture in India
  • Brazil and Uruguay undertake cooperation agreement
  • Cooperation between Switzerland and Taiwan
  • Intellectual property
  • 12th AHWP meeting
  • Malaysia’s medical device regulations
  • Medical Devices National Registry trialled in Saudi Arabia
  • Implementation plan for Singapore’s device regulations
  • Regulations on HIV infection test kits published in Thailand
  • Thailand’s progress on physical therapy equipment rules
  • Adverse reactions: role of Thai manufacturers/importers

More >>

Environment Update

  • Mercury measuring instruments
  • Implementation of WEEE and RoHS Directives

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Standards Update

  • Updates to the quality management standards
  • Harmonised EU standards
  • Update to Canada’s list of recognised standards
  • Modifications to the list of US FDA recognised standards
  • US chemical indicator standards
  • Water quality for reprocessed devices
  • Harmonisation of cooperation between CEN and CENELEC

More >>

Reference Information

  • Regulatory personnel on the move
  • Meeting report of 11th GHTF conference
  • Country overview: the Ukraine
  • Elemental Essentials: advanced therapy medicinal products (ATMPs)
  • Book review: Guide to Microbiological Control in Pharmaceuticals and Medical Devices
  • Device regulation in the EU: multi-lingual glossary (F-L)

More >>