Regulatory Affairs Syndicator

Understanding US labelling requirements.

Med Device Technol. 2005 Sep;16(7):21-3

Authors: Donawa M

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.

PMID: 16259155 [PubMed - indexed for MEDLINE]

U.S. medical device reporting: who is responsible?

Med Device Technol. 2005 Apr;16(3):27-9

Authors: Donawa M

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.

PMID: 15871421 [PubMed - indexed for MEDLINE]

US importer and distributor requirements.

Med Device Technol. 2005 Jun;16(5):25-7

Authors: Donawa M

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.

PMID: 15984543 [PubMed - indexed for MEDLINE]

The Center for Devices and Radiological health: an update.

Med Device Technol. 2001 Dec;12(10):24, 26-7

Authors: Donawa M

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.

PMID: 15966141 [PubMed - indexed for MEDLINE]

When to conduct a clinical trial.

Med Device Technol. 2004 Oct;15(8):28-31

Authors: Boutrand JP

A clinical trial is designed to provide clinical evidence of compliance with the medical device Directives. Clinical evidence can also be based on systematic and objective literature review.This article highlights when to use the clinical or the literature route to demonstrate the safety and performance of a medical device.

PMID: 16225271 [PubMed - indexed for MEDLINE]

Successful recruitment for medical device clinical studies.

Med Device Technol. 2004 Oct;15(8):25-7

Authors: Donawa M

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.

PMID: 16225270 [PubMed - indexed for MEDLINE]