scholarly journals Export compliance for life sciences

2008 ◽  
Vol 14 (2) ◽  
Author(s):  
John Avellanet
Keyword(s):  
Research And Development ◽  
Medical Device ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Life Sciences ◽  
Regulatory Compliance ◽  
Technological Knowledge ◽  
Types Of Knowledge ◽  
Export Compliance ◽  
Compliance Programme

Long before worrying about US Food and Drug Administration compliance, organisations that work with foreign employees, contractors, vendors or partners need to be concerned with the importation and exportation of technological knowledge – the so-called ‘deemed exports’. This is particularly apt for executives in the biopharmaceutical, biotechnology and medical device fields who outsource research and development overseas or who hire non-US citizens. US export regulations have strict guidelines on the types of knowledge that cannot be shared with non-US citizens and carry harsh penalties for non-compliance that fall equally on the organisation in question and its executives who ought to have known better. This paper presents an eight-step strategy to develop a regulatory compliance programme that meets US export compliance regulations.

An analysis of food and drug administration medical device reports relating to total joint components

1997 ◽  
Vol 12 (7) ◽  
pp. 765-771 ◽  
Author(s):  
Frank P. Castro ◽  
George Chimento ◽  
Barry G. Munn ◽  
Richard S. Levy ◽  
Stephen Timon ◽  
...  
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Administration Medical

Neurosurgical materials and devices

1976 ◽  
Vol 45 (3) ◽  
pp. 251-258 ◽  
Author(s):  
Charles V. Burton ◽  
Joseph T. McFadden
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Medical Devices ◽  
Food And Drug Administration ◽  
International Standards ◽  
Current Status ◽  
Reference Source ◽  
Legal Authority ◽  
Content Type ◽  
Fine Print

✓ The current status of voluntary consensus standards writing procedures in neurosurgery and the current progress of government efforts to regulate materials and devices are described. A survey of the national and international standards writing bodies is presented, along with an introduction to related organizations and agencies and nomenclature. The intent of this review is to provide the neurosurgeon with a reference source regarding past and present neurosurgical activities in the materials and devices field. When President Ford signed the 1976 Medical Device Amendments on May 28, 1976, the Food and Drug Administration assumed direct legal authority to control medical devices and potentially assumed the power to regulate those professionals using them.

THE NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH1

1972 ◽  
Vol 35 (6) ◽  
pp. 335-339
Author(s):  
Dale R. Lindsay
Keyword(s):  
Research And Development ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Government Agencies ◽  
Research Centers ◽  
Academic Institutions ◽  
Hazardous Chemicals ◽  
Toxicological Research ◽  
The Many ◽  
National Resource

On January 26, 1971, President Nixon announced the establishment of a National Center for Toxicological Research (NCTR) at Pine Bluff, Arkansas. The Food and Drug Administration will administer tins facility in a manner that is responsive to the needs of the FDA, EPA, and other government agencies, when their programs require research and development suitable to the Center, The Center is to be a national resource to be shared and utilized by appropriate government agencies, academic institutions, and industry. It will not duplicate the research capabilities of existing toxicological centers, rather it will build upon this existing capability and technology and augment existing research programs by undertaking projects which are not possible at other research centers. The author discusses problems that have created the need for this Center and approaches that will be used to try to determine the risk that man runs in his every day exposure to the many hazardous chemicals in his environment.

A Review of Design for X Methods for Medical Devices: The Introduction of a Design for FDA Approach

2011 ◽  
Author(s):  
Lourdes A. Medina ◽  
Richard A. Wysk ◽  
Gu¨l E. Okudan Kremer
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Medical Devices ◽  
Development Process ◽  
Regulatory Compliance ◽  
Design For Manufacturing ◽  
Design For X ◽  
Device Development ◽  
Unites States ◽  
Fda Regulations

This paper focuses on the importance of the regulations, in particular the Food and Drug Administration (FDA), in the development of medical devices. The FDA regulates medical devices to assure that these products are safe and effective before their release into the Unites States market. We introduce the concept of Design for FDA (DfFDA) and describe DfFDA guidelines for medical device development. While many researchers describe the regulations in the form of reviews and models, the literature to date has not reported a DfFDA method. Here, DfFDA is proposed as a method to be used in parallel with other DfX methods when applicable. The DfX methods identified include: Design for Validation (DfV), Design for Reliability (DfR), Design for Quality (DfQ), Design for Manufacturing (DfM), Design for Assembly (DfA) and Design for Usability (DfU). This paper also reviews the literature addressing the FDA regulations and DfX methods, and an overview of the FDA regulations is presented. DfFDA is developed to increase awareness about regulatory compliance and promote designers to consider the regulations throughout the development process of medical devices.

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