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Browse English Issue Headlines - February 2011

Interview with Dr Jeffrey Shuren, Director, US FDA CDRH

Rosina Robinson speaks exclusively with Dr Jeffrey Shuren, Director, US FDA Center for Devices and Radiological Health. In this interview Dr Shuren is asked about his perspective on recent Center activities and CDRH and industry concerns surrounding the 510(k) Premarket Notification process, as well his impressions about the 510(k) process and its future.

Is there any way for industry to prepare to address the current perceived uncertainties in the regulatory process and shifts toward more conservative philosophies on the part of the CDRH? More >>

Reprocessing single-use medical devices: a risky business

Peter Schroeer, Chairman of the Eucomed Reuse Task Force, highlights the issues concerning the reprocessing of single-use medical devices in Europe and the US. This article reviews the key issues with a focus on patient safety, economic issues, and ethics and patient consent. More >>

Comparison of reimbursement arrangements in five Asian countries

The reimbursement of medical devices has become a key factor in determining access to medical devices in Europe. In Asia, however, the capacities and coverage of national health insurance systems differ tremendously and the concept of providing reimbursement for medical devices is just starting to gain momentum. Amit Kukreja and Amelia Leow compare the reimbursement landscape in five leading medical device markets in Asia, namely China, South Korea, India, Taiwan and Singapore. The level of healthcare financing coverage, usage of health technology assessment, price controls and experimentation with provider payment methods and pace of change across these countries are discussed. More >>

Clinical investigations in the US and the EU

Whether to conduct a clinical investigation of a new medical device can be one of the most important, and sometimes most difficult, decisions for manufacturers in both the US and the EU. It also is critical that manufacturers understand the regulatory requirements and the applications that must be submitted to regulatory authorities, in order to initiate a clinical study, and also to conduct and complete a study that will be suitable to support commercialisation of a device in the US or the EU. Steven B Datlof and Fabien Roy explore the requirements for conducting clinical studies in the US and EU. More >>

US requirements for radiation emitting medical devices

Leah Fischer and Fred Simpson (posthumously) provide an overview of the contemporary laws and regulations affecting a narrow class of products subject to US Federal control - specifically those medical devices that have radiological characteristics. They define radiation emitting products and medical devices, compare US FDA requirements for bringing each type of product to market, and examine ‘labelling’ provisions specifically related to radiological medical devices in an attempt to demystify the complex maze of FDA regulations related to radiation-emitting medical devices. More >>

European Update

  • Danish Executive Order concerning fees for medical devices
  • Commission guidance on clinical investigation of devices
  • Proposed guidance finalised: reporting of SAEs during clinical trials
  • Reprocessing of medical devices in the EC
  • EMA revises guidance on drug-device combinations
  • Scientific Risk Assessment Advisory Structure established
  • SCENIHR adopts opinion on the term ‘nanomaterial’
  • Eucomed Code of Ethical Business Practice new guidance
  • HAIs – Eucomed Working Group established
  • European NBOG report and work programme for 2011
  • Afssaps pilot phase for SAE reporting procedure for devices
  • German healthcare reforms indirectly affect medical device sector
  • IMB/Afssaps/MHRA PMS operation for blood glucose meters
  • Wholesale distribution of medical devices in Portugal
  • NICE guidance supports coronary artery device in the UK
  • UK Bribery Act implementation: April 2011
  • Medical Device Alerts from the UK MHRA

More >>

US Update

  • FDA 515 program initiative: reclassification of preamendment Class III 510(k)s
  • Reclassification of digital mammography systems to Class II
  • Classification of non-powered suction apparatus devices
  • Tissue adhesive with adjunct wound closure device classification
  • FDA revises regulations for informed consent
  • Automatic Class III designation (De Novo) decision summaries
  • Guidance issued on blood lancet labelling
  • Guidance: MQSA final regulations: modifications and additions
  • FDA draft guidance documents for IVD devices
  • Safety alerts from the FDA
  • Establishment Registration and Device Listing Database
  • Pivotal IDE descriptive summary form
  • FDA innovative external defibrillator initiative launched
  • Update on UDI system for medical devices
  • FDA withdrawal of guidance on lasers as medical devices
  • MDMA submits comments on ‘Parallel Review’ proposal
  • US/EC joint discussions on proposed EC legislative changes
  • FDA meetings
  • Industry costs for FDA 510(k) clearance and PMA approvals

More >>

International

  • Australian TGA medical devices regulatory reforms
  • Reforming public health procurement in Australia
  • Australian TGA Transparency Review Panel established
  • TGA risk-based approach to scheduling GMP audits
  • Australian/Canadian Memorandum of Understanding
  • Brazil issues Ordinance on conformity assessment procedures
  • New Class III medical device licence application form in Canada
  • Health Canada issues draft guidance on content of QMS audit reports
  • STED-based Class III and Class IV applications – draft Canadian guidance
  • E-labelling of medical devices in Canada
  • Software regulated as a Class I or Class II device in Canada
  • Chinese SFDA relocates
  • Colombia proposes establishment registration for IVD producers
  • Registration of medical devices in Egypt
  • GHTF publications
  • AdvaMed urges Japanese regulators to speed up approval process
  • Malaysian draft guidance documents issued for comment
  • Regulatory reforms in Mexico
  • Nicaragua issues Health Law
  • Peru issues Directive on GMP certification
  • Draft regulations on medical device establishments issued in Peru
  • Implementing Rules amended by Saudi FDA
  • Saudi Arabia hosts international conference on medical devices
  • Singapore: revised guidance on Good Distribution Practices
  • SAMED position on device company representatives in hospitals

More >>

Environment Update

  • RoHS recast update
  • Chemicals in Europe - classification and labelling notifications

More >>

Standards Update

  • New industry standards for medical devices in China
  • New ISO standard on dry heat sterilisation of medical devices
  • International medical device clinical study standard revision
  • Israel standard amendment and change to implementation date
  • Swiss revised list of standards for medical devices
  • IEC 60601-1 FAQ published by UL
  • CEN/CENELEC launch web portal to assist SMEs
  • AAMI Technical Information Report for device reprocessing

More >>

Reference Section

  • Regulatory personnel on the move
  • Country overview: Saudi Arabia
  • Elemental Essentials: European guidance documents for medical devices (MEDDEVs)

More >>