Biomedical subjects
Publications and source records attributed to Maria Donawa.
There is no official form for submitting a United States premarket notification or 510(k) submission. A recent Food and Drug Administration guidance document describes the manner in which this type of premarket submission should be formatted. This article discusses this document and so me important aspects of the 510(k) process.
The development of comprehensive accurate and well-organised technical documentation that demonstrates compliance with regulatory requirements is a resource-intensive, but critically important activity for medical device manufacturers. This article discusses guidance documents and method of organising technical documentation that may help avoid costly and time-consuming duplication.
Medical device manufacturers do not always properly control the development of new or modified promotional labelling and advertising materials. This lack of control can lead to unexpected regulatory problems. This article discusses United States requirements for these materials and the type of controls that companies should exercise.
Medical device manufacturers do not always recognise that the process of identifying and controlling risks is most effective if risk-related activities are incorporated into their quality systems. This article discusses a guidance document that provides practical suggestions for accomplishing this important task.
The United States premarket approval (PMA) process is costly and time-consuming and differs in important ways from the CE-marking process. This article discusses the importance of strategic planning for submission of a PMA and the issues that should be considered, which can lead to a reduction in the time and cost involved.
Manufacturers conducting clinical studies to support medical device safety and performance claims need to ensure that clinical study data are appropriately managed. Not doing so can risk the success of the project related to the clinical study. This article discusses a guideline that can assist in this effort.
Under United States regulations, the Food and Drug Administration may require manufacturer to collect postmarket clinical data. In Europe, the role of postmarket clinical follow-up is described in a guidance document, but not specifically mentioned in the European Directives. This article discusses the two systems, which are similar, but also different in important aspects.
When various companies are involved in the manufacture and export of medical devices to the United States (U.S.), it is not always easy to understand the reporting responsibilities under the U.S. Medical Device Reporting regulation. A new rule has been published to help companies better understand the requirements. This article discusses the new rule, ways to determine responsibilities and suggestions for compliance.
Competent Authorities are developing increasingly active market surveillance programmes. As a result, they are initiating or broadening the scope of inspection visits. This article discusses the manner in which some of these visits are being conducted and actions that should be taken to prepare for them.
A medical device manufacturer who exports products to the United States (US) may risk success in this activity by not being aware of US importer and distributor requirements. This article discusses the requirements and actions that nonUS manufacturers should take to ensure these requirements are met.
Medical device manufacturers should not assume that the information and symbols on labels for the European market are always suitable to meet United States (US) requirements. This article discusses US labelling requirements and how they differ from European requirements.
Medical device manufacturers conduct clinical studies in Italy for various reasons, including the size of the Italian market and the presence of leading health-technology centres. This article discusses the manner in which the European requirements for medical device clinical investigations are interpreted and enforced in Italy.
The use of software in medical devices and their accessories has led to significant improvements in clinical diagnosis and treatment of a vast range of illnesses. However, to benefit patients and users, device-related software must be properly developed and tested before use. This article discusses a United States guidance document that describes the type of documentation needed to show that this has been done.
Considerable uncertainty exists regarding European requirements for withdrawing a product from the market because of product performance problems that are not related to serious health risks or death. This article discusses the requirements for product returns or other related actions that are outside the scope of the recall notification requirements defined in the medical device Directives.
After expending considerable effort to comply with United States (US) marketing authorisation regulations, a company launched its first product on the US market. Unfortunately, the company failed to comply with other applicable US regulations, which led to a delay in the US product introduction and FDA postmarketing enforcement actions against the product. This article discusses ways that companies can prevent this from happening.
Far too many medical device companies are failing to reap the benefits of an effective risk management programme. Thus, patients, users and the companies themselves are continuing to suffer the consequences of device problems that could have been identified and resolved before products are placed on the market. This article discusses how to implement an effective programme.
Inadequate subject enrollment represents a significant obstacle during a medical device clinical investigation. It can lead to costly delays and jeopardise the success of an entire device development project. This article discusses the importance of devising an effective subject recruitment strategy so that clinical and regulatory requirements can be met.
By the spring of 2005, the European Commission hopes to present the first draft of the revisions to the Medical Device Directive to the European Council and Parliament. However, these revisions represent only part of the changing European regulatory scenario. This article discusses a tangible shift in European medical device regulatory policy and some actions that companies can take to understand and prepare for these policies.