Biomedical subjects
Publications and source records attributed to Maria Donawa.
Companies preparing United States (US) premarket submissions should be aware of a US policy that may save them time and money. This policy allows the grouping or "bundling" of multiple devices or multiple indications for use in a single submission. This article discusses this policy and a US guidance document that explains when bundling is appropriate.
An effective evaluation of the functioning of the Medical Device (MD) Directive is of the utmost importance and has global significance. This article discusses the official review of the MD Directive, its conclusions, and some of the more important activities resulting from the review.
The United States Food and Drug Administration (FDA) has decided to reexamine its regulations for electronic records and signatures, and during this process, to reduce the enforcement of some of the provisions of the regulations. This article discusses FDA's decision and the content of its related, recently issued guidance document.
The Competent Authority has been notified. The clinical investigator is anxious to begin. Just when the process of conducting a clinical investigation is proceeding as planned, the ethics committee issues an unfavourable opinion. This article discusses the actions that should be taken to avoid this occurrence and how to meet other requirements related to ethics committees.
One of the most difficult decisions that medical device companies may face is whether or not to report an adverse event to regulatory authorities. This article discusses a series of UK vigilance guidance documents for device implants designed to assist manufacturers in making these decisions and the wider value to industry that these documents may have.
During the course of a clinical investigation, changes may need to be made to the device, the manufacturing process, the investigational plan or other aspects of the investigation. Part I of this article discusses the United States requirements for managing these types of changes. Part II will discuss European requirements and the need for developing a standard operating procedure to help ensure consistent compliance.
What are the European requirements for managing changes that may occur during a clinical investigation? Part II of this article discusses these requirements and the development of a standard operating procedure to help ensure consistent compliance.
Anyone with a vested interest in the European medical device industry should be encouraged by the progress that has been made in establishing the comprehensive regulatory system for medical devices that now exists in Europe. However, significant challenges remain. This article discusses current initiatives and plans for the coming year for meeting those challenges.
A previous article discussed the impact that new quality management system standards are likely to have on the CE-marking process. The draft international standard for medical device quality systems has now been published. This article will discuss important issues related to the new standard.
The United States Food and Drug Administration (FDA) places considerable importance on the validation of software contained in and used to design, develop, or manufacture medical devices. This article discusses a recently published final FDA guidance document on software validation and the reasons for its importance.
The European harmonised standard for the clinical investigation of medical devices, published in 1993, will be replaced in 2003 by a new clinical investigation standard, which includes clearer guidance on the general requirements for medical device clinical investigations. In addition, another standard will also be published on clinical investigation plans. This article discusses the first of these two standards.
The United States (US) Food and Drug Administration (FDA) has established a Combination Products Programme and developed a new internal procedure to increase its effectiveness in regulating products consisting of combinations of drugs, devices and biological products. This article provides a brief overview of the FDA regulation of combination products and discusses the new Programme.
The requirements are changing for documentation and evaluation of adverse events that occur during clinical investigations of medical devices. This article discusses important amendments to adverse event definitions contained in a draft international standard and methods for improving the process of managing these types of events.
A new law authorises the Food and Drug Administration to collect fees on medical device premarket submissions. The law also introduces important medical device regulatory reforms. This article discusses this new law and comments on the impact that it could have on the medical device industry.
The United States (US) Food and Drug Administration (FDA) has recently published a final rule that will require medical device establishments located outside the US and whose products are imported into the US, to register with FDA and identify a US agent. This article discusses the new establishment registration and US agent requirements.
In less than nine months, manufacturers of medical devices containing certain types of tissues of animal origin will need to ensure that their products comply with newly mandated specifications. They should not wait until the last minute to begin this work. This article discusses the important issues that will need to be addressed to ensure effective compliance with the requirements.
As 2005 came to a close, the European Commission issued its formal proposal for a Directive amending the medical devices Directives. This article discusses certain aspects of the proposed amendments and encourages readers to review them in their entirety.