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Browse English Issue Headlines - August 2005

FDA's Office of Combination Products: Roles, Progress and Challenges

Given the diversity in the types of combination products, a 'one size fits all' approach to combination product regulation is probably not the answer. To ensure that the regulation of combination products is as clear, consistent and predictable as possible, the US Food and Drug Administration (FDA) established the Office of Combination Products (OCP), as required by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). The OCP's primary responsibilities are to ensure the prompt assignment of combination products to Agency Centers, and to oversee their 'timely and effective' premarket review and 'consistent and appropriate' postmarket regulation. The OCP also develops guidance and regulations to help clarify the regulation of combination products.

The OCP established its initial priorities based on direction from Congress in MDUFMA, as well as input from its stakeholders both within and outside the Agency. Mark D Kramer, Director of the OCP, addresses each of these priorities and looks forward to the future role of the OCP. More >>

Beyond Medical Device Vigilance

Post-marketing surveillance is playing an increasingly important role in ensuring the safety of medical devices and in advancing good design. The vigilance system was established in Europe as a result of Article 10 of Directive 93/42/EEC. This Article in the legislation provides the statutory basis for safety monitoring and reporting in the European Union. The Directive does not specify how the system should operate; this has been established through a series of agreements and guidelines. The development of the European system has both contributed to, and received assistance from, the international work of the Global Harmonisation Task Force and in particular from Study Group 2. This means that the principles and definitions for reporting events are essentially internationally harmonised, with common reporting forms for manufacturers. Inevitably some local variations remain, often because of different legal requirements.

In this article, Dr David Jefferys explains that, in his opinion, the post-marketing surveillance of medical devices has reached an interesting stage. Whilst the vigilance system remains the bedrock of the system, it has to be supplemented by other approaches. These may become increasingly important especially as the nature of the medical device product changes. In the future we may be looking at an integrated healthcare products safety monitoring system. More >>

German Industry Association Task Force on the 'Act on Medical Devices' [in German]

On 29 March 1996, the German medical device industry associations established a new alliance under the name of Arbeitsgruppe 'MPG' der Industriefachverbände (AG MPG, German Industry Association Task Force on the 'Act on Medical Devices'). The foundation of AG MPG was as a consequence of the enforcement of the German Medical Device Law (Medizinproduktegesetz, MPG) on 1 January 1995 linking the legal and regulatory interests of all national industry associations concerned.

An issue of common interest to the member associations has always been to inform the public about the precise meaning of the CE marking for medical devices, thereby avoiding unnecessary additional tests covering the same aspects and requirements that are detailed in the MPG. At the same time the CE marking had to be defended against various attempts driven by interested parties to reduce its significance to virtually nothing.

As a result, the AG MPG developed a leaflet entitled The meaning of the CE marking for medical devices, which is displayed as an annex to Rainer Hill's article. The article also contains a chart detailing who the German medical device industry associations are, how many German companies they represent and which one is their European representative organisation. More >>

ISO 14698 – Microbiology meets Risk Analysis?

The ISO 14698 series of standards entitled Cleanrooms and associated controlled environments – Biocontamination control was published in 2003 and consists of three Parts (only Parts 1 and 2 are discussed in this article). These standards appear to remain relatively unknown in the medical devices industry, and compliance to them is rarely requested by customers or claimed by manufacturers. However, according to David R Pickard, ISO 14698 Parts 1 and 2 are an important addition to the existing range of cleanroom standards, quality systems and Directives that skirt around microbiological monitoring requirements.

Some parts of the ISO 14698 standards appear to be mandatory (if a claim of compliance to the standard is made) by the use of the word 'shall'. However, there is sufficient use of the word 'should' to allow for discretion and interpretation to comply with the standard, whilst creating a useful and workable formal system that can be of great benefit to different medical device manufacturers and different products.

The standards do not call for additional testing and hence additional cost and administration, but propose a structured and logical means to review current procedures and practices with the potential to streamline and re-focus existing testing to give the most appropriate level of microbiological control. More >>

Human and Animal Tissue Regulation in Europe

The regulations that cover the use of animal and/or human tissue in medical device applications cannot be more different. Non-viable animal tissue has been used for many years in medical device applications, and is covered by a heavy regulatory platform based primarily on the reduction of risk related to the transfer of transmissible spongiform encephalopathy and other viruses. Conversely, human tissue is an extremely dynamic area both in terms of products and burgeoning regulation. Different again, is the use of viable animal tissue, which has had a chequered regulatory history resulting in ethical as well as technical challenges.

In this article, Phil Brown and Thierry Chignon describe the current situation faced by industry with regards to the gaining of regulatory acceptance for each of these three areas and attempt to shed some light on the expected future. More >>

European Update

  • Medical Devices Act in Estonia
  • Public consultation on MDD revisions
  • Reclassification of orthopaedic implants
  • MEDDEV on devices utilising animal tissues now available
  • Consultation on human tissue engineering regulation
  • Electronic labelling for IVDs
  • Devices containing DEHP plasticised PVC
  • Luxembourg and Belgium fail to transpose Directive 2002/58/EC
  • Medical technology innovation in the EU
  • French quality control of osteodensitometry devices
  • New German Agency for Drugs and Medical Devices
  • Swedish MPA Head of Unit reported to the public prosecutor
  • Payment for clinical investigations in Sweden
  • Two draft Swiss regulations issued for comment
  • Insurance coverage for clinical trials
  • Good Maintenance Practice in the medical technology field
  • Tooth whiteners: Swiss viewpoint
  • Medical Device Alerts issued by the UK MHRA

More >>

US Update

  • Dental devices: reclassification and classification
  • Medical device reporting requirements
  • Performance standard for diagnostic x-ray systems
  • Human cells, tissues and cellular and tissue-based products
  • Guidance on software in medical devices
  • Unique device identification
  • Reprocessing and reuse
  • Modifications to the list of FDA recognised consensus standards

More >>

International

  • TGA fees and charges
  • Australian legislative proposals
  • End of transition period for single-use devices approaches
  • TGA fact sheets: re-use of single-use medical devices; electrical drug infusion devices; and Australian/EU regulatory systems
  • Australia's prostheses reimbursement scheme
  • Canadian medical device problem report form
  • Canadian regulations for developing countries
  • Private label medical devices: Canadian guidance available
  • Health Canada document on quality management
  • Summary Basis of Decision: a reader's guide
  • Update on China's registration procedures
  • Chinese SFDA inspection of packaging and labelling
  • Refurbished medical devices in China
  • Trans-Pacific Free Trade Agreement
  • US/Dominican Republic Free Trade Agreement
  • Report on EU/Canada summit
  • Australia/New Zealand joint standards committee established
  • Co-operation agreement between ECOS and CENELEC
  • Adverse event reporting in Japan
  • Korea's deregulation plans
  • Regulation proposed on medical product advertising in Malaysia
  • Safety of dental fillings: Singaporean MoH viewpoint
  • Thai requirements concerning Certificates of Free Sale
  • Prescription medical devices
  • Thai FDA medical devices law

More >>

Environment Update

  • Electrical and electronic equipment

More >>

Standards Update

  • Standards harmonised under Directives 90/385/EEC, 93/42/EEC and 98/79/EC

More >>

Reference Information

  • Elemental essentials: 510(k)s
  • Country overview: Thailand
  • New Approach Regulations - Part 3
  • ISO 13485: 2003 definitions explained
  • Book review of FDA Regulatory Affairs, A Guide for Prescription Drugs, Medical Devices & Biologics

More >>