Maria Donawa - Academia.edu (original) (raw)

Papers by Maria Donawa

Elsevier eBooks, 2011

Abstract: To ensure that patients and users benefit from novel biomedical hydrogels with medical ... more Abstract: To ensure that patients and users benefit from novel biomedical hydrogels with medical applications, anyone involved in the design and development of these products should be aware of the increasingly strict regulatory requirements that these products must meet before they can be placed on the market. This chapter will discuss important issues that should be taken into consideration when hydrogels are regulated as medical devices, concentrating on the United States (US) and Europe. For example, the US and Europe regulate medical devices in different ways, each with its own regulatory framework, although efforts to harmonize these requirements are under way.

CRC Press eBooks, Nov 20, 2013

A new European guideline on drug-eluting stents (DES) introduces for the first time detailed info... more A new European guideline on drug-eluting stents (DES) introduces for the first time detailed information that European drug authorities should review concerning the medicinal substance that is incorporated into this type of drug-device combination product. Part I of this article discusses European requirements that apply to DES. Part II will discuss the new guideline, other stent guidelines and evolving process of drug-device regulatory review in Europe.

European Member States are under no obligation to translate their national laws and regulations i... more European Member States are under no obligation to translate their national laws and regulations into any language other than their own official languages. Companies are responsible for understanding the medical device requirements in a particular Member State regardless of the languages involved.This article discusses this challenge and some methods for addressing it.

Medical device technology, 1995

Companies preparing for compliance with the European quality system standards and US Good Manufac... more Companies preparing for compliance with the European quality system standards and US Good Manufacturing Practice regulations must comply with the process validation requirements that apply to their manufacturing processes. Effective planning for compliance is fundamental for companies with processes that must be validated, monitored, and controlled. This article discusses the basic elements of a Validation Master Plan, which can greatly facilitate this planning process.

Medical device technology, 1996

On 11 December 1995, the United States (US) Food and Drug Administration (FDA) published new medi... more 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.

Medical device technology, 1994

There are a number of important issues currently facing the European Commission on the interpreta... more There are a number of important issues currently facing the European Commission on the interpretation and implementation of the Medical Device Directive (MDD). One of these concerns medical device sterilizers used in hospitals, physicians' or dentists' offices, or other medical settings, and whether they should be regulated under the MDD. Any decision made on this issue could have important implications on future decisions of whether or not to include a product under the European medical device regulatory scheme. For this reason, the medical device industry in general, not only manufacturers of sterilizers, should be aware of this issue. The industry should also understand the implications of the resulting policies that may be developed. This article will point out some of the factors that could influence the European decision-making process. It will also provide information on the regulatory approach that the US Food and Drug Administration (FDA) has taken towards sterilizers.

Public health reports (Washington, D.C. : 1974)

Medical device technology, 2009

The successful launch ofa combination product in the United States (US) will depend on how well a... more The successful launch ofa combination product in the United States (US) will depend on how well a company understands applicable US regulations and policies, which differ in important ways from requirements in Europe. This article provides an overview of useful information on the US regulation of these products that can be found on the newly redesigned Food and Drug Administration website.

Medical device technology, 2009

The European Commission has recently updated an important guidance document on determining whethe... more The European Commission has recently updated an important guidance document on determining whether or not a medical product is subject to medical device or medicinal product regulations. In addition, a new manual that provides practical examples has also been issued. This article discusses these documents.

Far too many medical device companies are failing to reap the benefits of an effective risk manag... more 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.

Medical device technology, 2010

US FDA is considering introducing some bold changes to the 510(k) review process. A new report de... more US FDA is considering introducing some bold changes to the 510(k) review process. A new report describes these considerations, including the possible creation of a new Class IIb device subset.

Medical device technology, 2008

Medical device companies do not always realise that United States and European test requirements ... more Medical device companies do not always realise that United States and European test requirements can be significantly different. Not addressing these differences can be costly when retesting or device redesign becomes necessary. This article discusses some of these differences and ways to help avoid repeat testing.

Medical device manufacturers conducting clinical studies outside the United States (US) to suppor... more Medical device manufacturers conducting clinical studies outside the United States (US) to support US regulatory submissions should be prepared to show that these studies are conducted in a manner that will be acceptable to the Food and Drug Administration. This article discusses the audits that can be conducted to assess this acceptability.

Medical Device Technology, 2009

Medical device companies need to meet European requirements designed to protect the environment.T... more Medical device companies need to meet European requirements designed to protect the environment.The deadlines for some of the requirements have already passed. This article discusses a European Regulation and two Directives, and a means for meeting environmental requirements in an effective manner.

Medical Device Technology, Oct 1, 2008

Medical device companies do not always realise that United States and European test requirements ... more Medical device companies do not always realise that United States and European test requirements can be significantly different. Not addressing these differences can be costly when retesting or device redesign becomes necessary. This article discusses some of these differences and ways to help avoid repeat testing.

Medical Device Technology, Jul 1, 2005

A medical device manufacturer who exports products to the United States (US) may risk success in ... more 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.

Elsevier eBooks, 2011

Abstract: To ensure that patients and users benefit from novel biomedical hydrogels with medical ... more Abstract: To ensure that patients and users benefit from novel biomedical hydrogels with medical applications, anyone involved in the design and development of these products should be aware of the increasingly strict regulatory requirements that these products must meet before they can be placed on the market. This chapter will discuss important issues that should be taken into consideration when hydrogels are regulated as medical devices, concentrating on the United States (US) and Europe. For example, the US and Europe regulate medical devices in different ways, each with its own regulatory framework, although efforts to harmonize these requirements are under way.

CRC Press eBooks, Nov 20, 2013

A new European guideline on drug-eluting stents (DES) introduces for the first time detailed info... more A new European guideline on drug-eluting stents (DES) introduces for the first time detailed information that European drug authorities should review concerning the medicinal substance that is incorporated into this type of drug-device combination product. Part I of this article discusses European requirements that apply to DES. Part II will discuss the new guideline, other stent guidelines and evolving process of drug-device regulatory review in Europe.

European Member States are under no obligation to translate their national laws and regulations i... more European Member States are under no obligation to translate their national laws and regulations into any language other than their own official languages. Companies are responsible for understanding the medical device requirements in a particular Member State regardless of the languages involved.This article discusses this challenge and some methods for addressing it.

Medical device technology, 1995

Companies preparing for compliance with the European quality system standards and US Good Manufac... more Companies preparing for compliance with the European quality system standards and US Good Manufacturing Practice regulations must comply with the process validation requirements that apply to their manufacturing processes. Effective planning for compliance is fundamental for companies with processes that must be validated, monitored, and controlled. This article discusses the basic elements of a Validation Master Plan, which can greatly facilitate this planning process.

Medical device technology, 1996

On 11 December 1995, the United States (US) Food and Drug Administration (FDA) published new medi... more 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.

Medical device technology, 1994

There are a number of important issues currently facing the European Commission on the interpreta... more There are a number of important issues currently facing the European Commission on the interpretation and implementation of the Medical Device Directive (MDD). One of these concerns medical device sterilizers used in hospitals, physicians' or dentists' offices, or other medical settings, and whether they should be regulated under the MDD. Any decision made on this issue could have important implications on future decisions of whether or not to include a product under the European medical device regulatory scheme. For this reason, the medical device industry in general, not only manufacturers of sterilizers, should be aware of this issue. The industry should also understand the implications of the resulting policies that may be developed. This article will point out some of the factors that could influence the European decision-making process. It will also provide information on the regulatory approach that the US Food and Drug Administration (FDA) has taken towards sterilizers.

Public health reports (Washington, D.C. : 1974)

Medical device technology, 2009

The successful launch ofa combination product in the United States (US) will depend on how well a... more The successful launch ofa combination product in the United States (US) will depend on how well a company understands applicable US regulations and policies, which differ in important ways from requirements in Europe. This article provides an overview of useful information on the US regulation of these products that can be found on the newly redesigned Food and Drug Administration website.

Medical device technology, 2009

The European Commission has recently updated an important guidance document on determining whethe... more The European Commission has recently updated an important guidance document on determining whether or not a medical product is subject to medical device or medicinal product regulations. In addition, a new manual that provides practical examples has also been issued. This article discusses these documents.

Far too many medical device companies are failing to reap the benefits of an effective risk manag... more 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.

Medical device technology, 2010

US FDA is considering introducing some bold changes to the 510(k) review process. A new report de... more US FDA is considering introducing some bold changes to the 510(k) review process. A new report describes these considerations, including the possible creation of a new Class IIb device subset.

Medical device technology, 2008

Medical device companies do not always realise that United States and European test requirements ... more Medical device companies do not always realise that United States and European test requirements can be significantly different. Not addressing these differences can be costly when retesting or device redesign becomes necessary. This article discusses some of these differences and ways to help avoid repeat testing.

Medical device manufacturers conducting clinical studies outside the United States (US) to suppor... more Medical device manufacturers conducting clinical studies outside the United States (US) to support US regulatory submissions should be prepared to show that these studies are conducted in a manner that will be acceptable to the Food and Drug Administration. This article discusses the audits that can be conducted to assess this acceptability.

Medical Device Technology, 2009

Medical device companies need to meet European requirements designed to protect the environment.T... more Medical device companies need to meet European requirements designed to protect the environment.The deadlines for some of the requirements have already passed. This article discusses a European Regulation and two Directives, and a means for meeting environmental requirements in an effective manner.

Medical Device Technology, Oct 1, 2008

Medical device companies do not always realise that United States and European test requirements ... more Medical device companies do not always realise that United States and European test requirements can be significantly different. Not addressing these differences can be costly when retesting or device redesign becomes necessary. This article discusses some of these differences and ways to help avoid repeat testing.

Medical Device Technology, Jul 1, 2005

A medical device manufacturer who exports products to the United States (US) may risk success in ... more 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.