Biomedical subjects
Publications and source records attributed to M Donawa.
Medical device manufacturers who need contract sterilisation services sometimes lack extensive knowledge of the technical aspects of sterilisation processes. For this reason, they may have problems assessing quality requirements for subcontractor sterilisation services. This article discusses important quality issues that should be considered when selecting a sterilisation subcontractor.
If the United States (US) Food and Drug Administration (FDA) receives the funding that it has requested, it plans to increase inspections of clinical investigation sites both in the US and abroad. This article discusses US clinical investigation requirements and guidance documents that should be reviewed when preparing for FDA clinical site inspections.
Explore the source record for details and available documents.
For some time now, the only publicly available compliance programme guidance manual on medical device inspections and administrative and enforcement activities has been a draft document. On 7 February 2001, a final guidance document was issued. This article discusses this document and its importance to non-US medical device manufacturers preparing for FDA facility inspections.
The United States Food and Drug Administration (FDA) is in the process of developing and issuing a series of guidance documents on electronic records and signatures requirements. This article discusses two recently published FDA guidance documents: validation requirements for electronic records and signatures and a glossary of terms. It also highlights the need for industry to provide comments on these documents to FDA.
The European medical device Directives require the establishment of a centralised database for storing regulatory information and data on medical devices. The work to establish this system is progressing and the database may be operational within 18 to 24 months. This article discusses the work that has been done to establish the database, the types of data to be stored in it, and the current status of the project.
The United States Food and Drug Administration (FDA) has announced its intention to launch an extraordinary new pilot programme that could have a significant effect on efforts to harmonise premarket review procedures worldwide. This article discusses the programme and the importance of submitting comments to FDA on this new initiative.
At a recent medical device conference, Dr. David Feigal, the Director of the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) stated that one-third of the CDRH staff will retire in five years. This is only one of many challenges that the Center faces.This article discusses key factors shaping current FDA device policies and programmes, the CDRH strategic plan, the continuing importance of the standards programme, and CDRH harmonisation activities.
The history of the United States (US) Medical Device Reporting (MDR) Regulation is long and complicated. This has made compliance with the requirements an especially challenging exercise. The publication of a new regulation clarifies some outstanding reporting issues, but not all. Part I of this article includes a chronology of MDR regulations and discusses some requirements that should be of particular interest to non-US companies. Part II will discuss the contents of the new MDR regulation.
Part I of this article discussed the chronology of the United States (US) Medical Device Reporting (MDR) regulations, the suspension of the US Designated Agent requirements, and important considerations concerning reporting responsibilities for non-US manufacturers. This article will discuss the contents of the recently published MDR final rule.
This article discusses the Notified Body recommendations issued by the European Forum of Notified Bodies Medical Devices and its subcommittee, the Notified Bodies Recommendations Group. Most of these recommendations represent more detailed guidance documents than the consensus statements issued by this group, which were discussed in a previous article. Some of the recommendations form the basis of the European-level MEDDEV guidance documents.
Explore the source record for details and available documents.
Non-US manufacturers marketing in vitro diagnostic (IVD) products in the United States (US) or planning to do so should be aware of a US Food and Drug Administration (FDA) manufacturing guideline. Although it needs to be updated to include design controls and a few other requirements in the current Quality System Regulation, it provides useful information on FDA's position regarding the manufacture of these products.
In spite of diverse challenges, medical device companies are continuing to design and develop high quality products that significantly benefit patients. They are also succeeding in meeting increasingly stringent regulatory requirements. However, these accomplishments do not guarantee commercial success. The importance of designers considering the needs of purchasers during the design phase is examined.
Under the European Directives, manufacturers must demonstrate that medical devices are safe, perform as intended, and that any associated risks are acceptable. Where appropriate, these characteristics should be based on clinical data. This article discusses guidance documents developed to assist Notified Bodies in reviewing the manufacturer's evaluation of clinical data.
The ability of governments, official bodies, industry and others to uniformly interpret the European Directives for medical devices will have a profound effect on the success of the European system regulating these products. This is particularly important for Notified Bodies. This article will discuss Notified Body consensus statements. An article in the near future will discuss Notified Body recommendations.
In a remarkably short time, the European regulatory landscape for medical devices has changed dramatically and permanently. The speed of this change will continue to accelerate until a fully matured body of rules is in place. This article will examine the current status of regulations in Europe, and some areas that will need to be addressed in the next century.
Article 21 of the In Vitro Diagnostic (IVD) Directive (98/79/EC) contains several important amendments to the Medical Device (MD) Directive (93/42/EEC). This is generally well known. However, the amendments are not always being kept in mind when discussing the requirements of the MD Directive. This article reviews the more important amendments and suggests that it is time to begin planning for them. The new definition of IVD products is also provided.