Biomedical subjects

M E Donawa

Publications and source records attributed to M E Donawa.

At least 19 recordsLinked to original sources

PubMed1999

Use and recognition of consensus standards in US premarket submissions.

In the autumn of 1997, the United States Center for Devices and Radiological Health published a draft guidance document on the use of IEC 60,601 standards in the evaluation of pre-market submissions for electromedical devices. One year later, an important legislative reform act caused this draft to be withdrawn because it allowed the Food and Drug Administration (FDA) to formally recognize standards covering all types of medical devices and not just those related to electrical products. This article discusses the benefits to manufacturers of this new FDA policy and the associated guidance documents that FDA has made available.

Humans↗

PubMed1999

An improved draft guidance to process validation.

The Global Harmonization Task Force has just released a new revised draft guidance on process validation. Although it contains much of the information included in the previous draft, some points have been added, and some that were confusing or not helpful have been clarified or eliminated. This article discusses the contents and usefulness of the latest draft process validation guidance document.

Equipment Design↗

PubMed1999

Drug delivery: the strategic advantage of design controls.

An interesting dichotomy exists in the regulation of drug-delivery products. If they are regulated as devices, there is a strong likelihood that new products will be designed and developed under documented design control programmes. There is less chance of this if they are regulated as drugs. This article discusses the benefits and added value of designing and developing all drug delivery products under a documented design control programme.

Device Approval↗

PubMed1999

New FDA draft guidance on premarket submissions.

The United States Food and Drug Administration (FDA) has issued a draft guidance document on the type of quality system information to be included in various premarket submissions. This is the same information that should be maintained at the manufacturing facility for devices subject to the premarket notification or 510(k) process. This article discusses the contents of the draft guidance and recommends that manufacturers send their comments on the guidance to FDA.

Device Approval↗

PubMed1998

Refurbished medical equipment.

The European medical device Directives apply to persons who fully refurbish medical equipment and place these products on the market under their own names. However, the Directives do not address any other type of refurbishing. This article discusses the European and United States (US) regulatory requirements for refurbishers, raises some questions concerning these requirements, and discusses a US advance notice of proposed rule making on refurbishers.

Consumer Product Safety↗

PubMed1998

Implementation of the Medical Device Directive in Italy.

The implementation of the European medical devices Directives by Member States is introducing a significant regulatory uniformity to the European regulation of medical devices. However, Member States are not required to implement the Directives in an identical manner. As a result, it is important to be aware of national variations. This article will discuss the implementation of the Medical Device Directive in Italy.

Durable Medical Equipment↗

PubMed1998

US quality system requirements for software validation.

United States (US) Food and Drug Administration (FDA) investigators have, for many years, consistently evaluated compliance with US process validation requirements. Until now there has been significant variability in the manner in which they have examined compliance with US requirements for the validation of software used in the production process or as part of the quality system. This article will discuss the contents of a recent FDA draft guidance document that may reduce this variability.

Equipment Safety↗

PubMed1998

The responsibilities of importers and distributors.

The European Directives for medical devices impose significant responsibilities on manufacturers, Member States and Notified Bodies. However, the Directives define far fewer responsibilities for importers and distributors. As a result, manufacturers and distributors do not always have a clear concept of these responsibilities nor of those specified by national laws and regulations. This article will discuss these responsibilities and some issues that should be considered in determining them.

Equipment and Supplies↗

PubMed1998

Process validation: harmonizing the requirements.

Medical device manufacturers marketing in Europe and the United States are faced with differing expectations regarding the quality system requirements for process validation. However, this may change as a result of a process validation guidance document being developed by the Global Harmonization Task Force. This article will discuss the document's current status, some of its elements and some suggested modifications.

Equipment and Supplies↗

PubMed1998

Avoiding unreasonable reliance on subcontractor certification.

Increasingly, subcontractors who provide products and services to device manufacturers are obtaining quality system certification. This is a laudable activity and should lead to improvements in the products and services being provided. However, some manufacturers place far too much reliance on this certification in their subcontractor assessment programmes. This article will discuss some of the dangers of this practice.

Accreditation↗

PubMed1998

Notifying the competent authorities.

The Medical Device Directive requires manufacturers or persons designated by them to provide Competent Authorities with certain types of information on some categories of medical devices. However, this requirement is often misinterpreted and there are some national variations related to the notification of Competent Authorities. This article will discuss Article 14 of the Directive, some frequent misinterpretations and, briefly, Germany's notification requirements.

Equipment and Supplies↗

PubMed1997

Servicing: meeting US and European quality system requirements.

Medical device manufacturers whose products must be serviced and who wish to meet both United States (US) and European quality system requirements should pay particular attention to the servicing provisions of these requirements. The current US medical device good manufacturing practice (GMP) regulation and the new US quality system regulation contain requirements that are not included in the European quality system standards. This article will discuss the major aspects of US and European servicing requirements and some important differences.

Equipment and Supplies↗

PubMed1997

European and US quality system requirements for packaging.

The packaging of medical devices bearing the CE mark must comply with the European Directives for medical devices. Packaging of medical devices marketed in the United States (US) must meet US requirements. Although these requirements are more stringent for sterile products, they apply to sterile and non-sterile products. This article will discuss the requirements, US guidance for complying with them, and some of the international and European standards for packaging that are available or being prepared.

Equipment and Supplies↗

PubMed1997

Complying with US and European complaint handling requirements.

The importance of customer complaints for providing valuable information on the use of medical devices is clearly reflected in United States (US) and European quality system requirements for handling complaints. However, there are significant differences in US and European complaint handling requirements. This article will discuss those differences and methods for ensuring compliance.

Consumer Product Safety↗

PubMed1997

Complying with US and European change control requirements, Part I.

The successful operation of medical device companies is significantly affected by their ability to continually improve their products and operations. Also, from time to time, problems need to be resolved. These activities are often associated with changes that must be made and effectively managed. Part I of this two-part article will discuss United States and European quality system requirements for controlling changes to products, processes and documentation. Part II will discuss change control procedures and regulatory notification issues.

Consumer Product Safety↗

PubMed1997

Complying with US and European change control requirements, Part II.

Part I of this two-part article discussed the United States (US) and European quality system requirements for controlling changes to products, processes and documentation. Part II will discuss some change control problems that can occur, the elements that should be included in change control procedures and records and the requirements for notifying regulatory authorities of changes.

Documentation↗

PubMed1997

User reporting systems.

Under the European vigilance system, manufacturers are responsible for reporting serious incidents or near incidents concerning medical devices to the relevant Competent Authority. However, the European Directives do not require users to report incidents. As a result, user reporting requirements vary among Member States. This article examines the manner in which user reporting is addressed in the European Directives and European vigilance guidance document, some examples of national user reporting systems, and some important issues concerning user reporting.

Equipment Failure↗

PubMed1996

Medical device reporting: the US final rule.

On 11 December 1995, the United States (US) Food and Drug Administration (FDA) published new medical device reporting (MDR) regulations for reports submitted by manufacturers and user facilities. The new regulations, which also revise the regulations for registration and listing, become effective on 11 April 1996. They also impose requirements on nonUS medical device manufacturers. This article discusses the new MDR requirements, including those related to nonUS medical device manufacturers.

Consumer Product Safety↗