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Journal of Medical Device Regulation Issue Headlines - November 2008

Demystifying Pre-Production Design Control for Marketing in the USA - How Does it Fit into Early Product Development?

The Safe Medical Devices Act of 1990 gave the Food and Drug Administration oversight of pre-production activities for medical devices in the USA. This article by Judy Andrews and Rosina Robinson describes the requirement for pre-production design control and how it fits into product development for new medical devices intended for marketing in the USA. The article is primarily directed at start-up or virtual companies without regulatory or quality professionals to guide them through this important activity. More >>

Directive 2007/47/EC Flatters to Deceive

The publication of the eagerly-awaited amending European Directive 2007/47/EC has evoked mixed reaction and misunderstanding from the medical device industry. While many regard the Directive as replacement for the Medical Devices Directive, others consider that it has changed the situation only very little or even imperceptibly. Even some Notified Bodies involved in assessing conformity to the Directives affected by Directive 2007/47/EC promulgate that few changes are wrought by the Directive. In this article, Haroon Atchia examines the nature of Directive 2007/47/EC, the key changes that it has introduced, and the corresponding regulatory and technical obligations on the manufacturer. Further, the sense that an opportunity was missed is considered. More >>

Compliance Auditing of a Device Company

All regulatory organisations require the companies that they regulate to be in compliance with the laws and regulations of their respective countries. To determine compliance, officials of the country can inspect or audit individual companies. This article by Robert Schiff describes the current approach to audits used by the author when auditing and inspecting medical device companies around the world, with particular emphasis on auditing in the USA. More >>

European Update

  • Modernisation of ‘New Approach’ is completed
  • Chemicals classification, labelling and packaging
  • Mandates of Scientific Advisory Committees revised
  • EMEA amends drug-eluting stent guidelines
  • ECHA identifies 14 substances of ‘very high concern’
  • List of chemicals exempt from certain REACH rules updated
  • Medical device safety legislation proposed in Finland
  • Data storage requirements for biomedical research in France
  • German Joint Federal Committee is re-established
  • Federal SHI Association created in Germany
  • Draft ‘German Hospital Financing Law’ published
  • New guidance documents issued by Irish Medicines Board
  • Clinical trial application procedure in the Slovak Republic
  • Clinical trial procedures in Switzerland
  • MHRA regulatory fees: proposals for 1 April 2009
  • Vigilance reporting in the UK
  • IVDs used in combination: UK Device Bulletin issued
  • UK Medical Device Alert
  • Consultation held on UK vigilance guidance documents

More >>

US Update

  • User fees for FY 2009
  • Hearing aids; baseline reports
  • Supplemental applications proposing labelling changes
  • Technical amendments to the Medical Device Regulations
  • Medical device tracking: guidance
  • Guidance affecting passive implants in the magnetic resonance environment
  • Guidance on clinical study designs for catheter ablation devices
  • Guidance on diagnostic ultrasound systems and transducers
  • Guidance on 510(k)s for intravascular administration sets
  • Draft guidance on clinical investigation of urinary incontinence treatment devices
  • Questions and answers on HDEs: draft guidance
  • Draft guidance on contrast imaging indication considerations
  • FDA announces improved policies for Advisory Committees
  • 2009 proposed guidance development
  • Consumer Product Safety Improvement Act of 2008
  • Congress approves anti-counterfeiting legislation
  • Bill proposes splitting the FDA into two
  • Senators introduce Bill to reverse Supreme Court decision
  • Post-market experience associated with LASIK devices
  • Pharmaceutical and medical device manufacturer conduct
  • HHS proposes adoption of ICD-10 code sets
  • Direct-to-consumer advertising for medical devices
  • Regulatory status of radiofrequency ablation of lung tumours
  • California proposes ban on PVC packaging
  • FDA conducts review of products containing BPA
  • US FDA offices to open in China, India, Europe and Latin America

More >>

International Update

  • Registration of prescription glasses in Argentina
  • Australia’s regulation of human cell and tissue therapies
  • Australia proposes regulation of hypoxicators
  • Update on Australia’s IVD regulatory framework
  • Other medical device regulatory developments in Australia
  • Australia continues consultation on ARGMD
  • Brazil updates standards for manufacture of condoms
  • Grouping of orthopaedic implants for registration at Anvisa
  • Simplified approval procedures for clinical trials in Brazil
  • Brazil holds public consultation on suppliers registry
  • Health Canada publishes Q&A document on DEHP and BPA
  • China’s State Council approves MoH reorganisation plan
  • China publishes enhanced device registration requirements
  • Chinese news headlines
  • India to implement electronic document management system
  • US to assist India in regulation of medical products
  • 8th ACCSQ-MDPWG meeting report
  • GHTF update
  • Japan proposes more regulatory staff and streamlined procedures
  • Kazakhstan to abolish VAT on certain medical products
  • South Africa’s Medicines Bill approved
  • Ukraine issues draft technical regulations on medical products

More >>

Environment Update

  • Mercury bans
  • Requirements of new Batteries Directive take effect

More >>

Standards Update

  • Harmonised EU standards
  • Modifications to the list of US FDA-recognised standards
  • Kenya’s standardisation marks
  • IEC and IEEE to co-develop international standards

More >>

Reference Information

  • Regulatory personnel on the move
  • Country overview: Singapore
  • Elemental essentials: QSIT
  • Book review of Medical Devices: European Union Policymaking and the Implementation of Health and Patient Safety in France
  • GHTF/SG2/N54R8:2006 – German translation (part 2)

More >>