Primer on medical device regulation. Part II. Regulation of medical devices by the U.S. Food and Drug Administration.

Radiology ◽  
1997 ◽  
Vol 205 (1) ◽  
pp. 10-18 ◽  
Author(s):  
L H Monsein
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Medical Devices ◽  
Food And Drug Administration ◽  
The U.S ◽  
Medical Device Regulation

scholarly journals US Food and Drug Administration Regulation of Medical Devices and Radiation Oncology: Can Reform Improve Safety?

2012 ◽  
Vol 8 (1) ◽  
pp. 53-56 ◽  
Author(s):  
Jona A. Hattangadi ◽  
James T. O'Reilly ◽  
Abram Recht
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Medical Devices ◽  
Radiation Oncology ◽  
Food And Drug Administration ◽  
Regulatory Framework ◽  
General Review ◽  
Medical Device Regulation

A review of the issues involved in medical device regulation in radiation oncology, including a general review of federal medical device regulation and explanations of the legal and regulatory framework.

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.

scholarly journals Comparison of Medical Device Regulations in India, Japan and South Korea

2021 ◽  
pp. 8-23
Author(s):  
Chandan B. V. ◽  
M. P. Venkatesh ◽  
Arjun M. ◽  
Pasupuleti Dheeraj Krishna ◽  
Indraprasad S.
Keyword(s):  
South Korea ◽  
Medical Device ◽  
Drug Administration ◽  
Drug Safety ◽  
Medical Devices ◽  
Food And Drug Administration ◽  
Asia Pacific ◽  
The South ◽  
South Korean ◽  
Medical Devices Act

Increased health awareness, a growing middle class, and government health efforts are projected to propel India's medical equipment market forward in the next years. With the publication of the Medical Device Rules in 2017, Indian authorities revised the medical device regulatory process. The devices included in the link are currently regulated medical devices and in vitro diagnostic devices, as well as their classifications. CLA (Central Licensing Authority) is in charge of all import device licencing, as well as manufacturing, loan, and wholesale licences for Class C and Class D medical devices. Because of its complicated registration process and linguistic obstacles, Japan is regarded one of the most difficult markets for overseas medical device producers. The Pharmaceutical and Medical Device Agency, which works in tandem with the MHLW (Ministry of Health and Labour Welfare), is in charge of reviewing drug and medical device applications in Japan. The Pharmaceuticals and Medical Devices Act is a federal law that regulates the sale of pharmaceuticals and medical devices. The Pharmaceuticals and Medical Devices Act, also known as the Act on Securing Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics, lays out the current PMDA (Pharmaceuticals and Medical devices Agency) laws in Japan. South Korea is one of the largest health-care markets in the Asia-Pacific region. Medical Devices in South Korea are regulated by the Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food and Drug Administration (KFDA). Medical Devices in South Korea are regulated by the Ministry of Food and Drug Safety, formerly known as the Korea Food and Drug Administration. The Medical Device Act of 2015 governs current medical device laws in Korea. To access the South Korean Medical-Device-Market, you must first obtain marketing approval from the local Medical Device Authority, the Medical Device Information & Technology Centre, which is part of the Ministry of Food and Drug Safety. With the MFDS notification No. 2020-29, the South Korean Ministry of Food and Drug Safety launched UDI (Unique Device Identification System) operations in 2018. Article 20 of the Medical Device Act and Article 54-2 of the Medical Device Act Enforcement Regulations make UDI compliance mandatory.

Premarket Review of Medical Devices in the United States

2000 ◽  
Vol 7 (3) ◽  
pp. 293-326
Author(s):  
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Regulatory System ◽  
The United States ◽  
The Public ◽  
The World ◽  
Contemporary Perspective ◽  
Premarket Approval ◽  
The U.S ◽  
Medical Device Regulation

AbstractIt has been sixty years since the Congress first authorized FDA to regulate medical devices. During this period, countless studies, reports, and investigations have been targeted at medical devices. The law has been significantly modified several times, and the regulations revised on numerous occasions. As for any other scheme of administration or management, revisions are necessary as demand arises for legislative attention to societal risks, the economy fluctuates, and when businesses expand and globalize. Studying the U.S. system of medical device regulation merely from a contemporary perspective fails to take into account the significance of decades of effort in maintaining the quality and integrity of the system in an ever-changing field of medical device regulation.The three-pronged medical device regulatory system that entails inspection of manufacturing facilities, premarket approval, and postmarket recall and reporting enables the public to benefit from medical devices without the fear of unreasonable risk with their use (Appendix 1). President Clinton proudly pronounced the following in a 1995 speech:Today, Americans don't have to worry about safety or effectiveness when they buy [drugs and medical devices] - from cough syrups to the latest antibiotics or pacemakers. The Food and Drug Administration has made American drugs and medical devices the envy of the world and in demand all over the world. And we are going to stick with the standards we have - the highest in the world.…^218

EU Medical Device Regulation 2017/745 versus US Food and Drug Administration approval of dermal filler products

2020 ◽  
Vol 9 (8) ◽  
pp. 320-324
Author(s):  
Kate Kelso
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Dermal Filler ◽  
The World ◽  
The Uk ◽  
The Eu ◽  
Medical Device Regulation

Regulations to which dermal filler manufacturers must adhere so as to bring a product to market vary across the world. It is recognised that standards of the EU Medical Device Directive were inadequate, and, as a result of this, it is due to be replaced by the EU Medical Device Regulation (MDR) ( EU 2017 /745) on 26 May 2021. The EU CE mark will continue to be recognised in the UK until 30 June 2023. Typically, the more rigorous US Food and Drug Administration (FDA) process has been more trusted, but will this still be the case when the MDR comes into force? This piece contrasts and compares the new EU MDR and FDA regulation from an injector perspective.

The Ear, Nose, and Throat Devices Classification Panel of the Food and Drug Administration

1979 ◽  
Vol 87 (1) ◽  
pp. 27-31
Author(s):  
Ralph F. Naunton ◽  
Harry R. Sauberman
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Medical Devices ◽  
Food And Drug Administration ◽  
Safety And Efficacy ◽  
Mode Of Entry ◽  
Nose And Throat

The passage into law in 1976 of the Medical Device Amendments authorized the FDA to regulate the safety and efficacy of medical devices. The effects of this regulation are contrasted with the mode of entry of medical devices onto the market prior to 1976. The structure and operation of Ear, Nose, and Throat Devices Classification Panel is described briefly. Continued input from otolaryngologists and allied professionals is encouraged.

HIV

2018 ◽  
Author(s):  
Joshua M. Sharfstein
Keyword(s):  
Public Health ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Research Process ◽  
National Institutes Of Health ◽  
Health Agencies ◽  
Act Up ◽  
The U.S

The emergence of AIDS in the early 1980s caused a profound crisis for federal health agencies, particularly the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA). Activists in ACT UP, charging that these agencies were failing patients with AIDS, initiated a series of escalating protests. NIH officials, led by Dr. Anthony Fauci, began to talk with the advocates and make major changes in the research process. However, over at the FDA, a protest involving the arrest of hundreds of AIDS activists undermined the agency’s public health image. Eventually, under a new commissioner, the FDA earned back the trust of activists.

Regulating Medical Devices in the United States

2020 ◽  
Author(s):  
Patricia J. Zettler ◽  
Erika Lietzan
Keyword(s):  
United States ◽  
Medical Device ◽  
Medical Devices ◽  
Complete Information ◽  
The United States ◽  
Risk Level ◽  
Management Tools ◽  
Medical Technologies ◽  
The Us ◽  
Medical Device Regulation

This chapter assesses the regulation of medical devices in the United States. The goal of the US regulatory framework governing medical devices is the same as the goal of the framework governing medicines. US law aims to ensure that medical devices are safe and effective for their intended uses; that they become available for patients promptly; and that manufacturers provide truthful, non-misleading, and complete information about the products. US medical device law is different from US medicines law in many ways, however, perhaps most notably because most marketed devices do not require pre-market approval. The chapter explores how the US Food and Drug Administration (FDA) seeks to accomplish its mission with respect to medical devicecough its implementation of its medical device authorities. It starts by explaining what constitutes a medical device and how the FDA classifies medical devices by risk level. The chapter then discusses how medical devices reach the market, the FDA's risk management tools, and the rules and incentives for innovation and competition. It concludes by exploring case studies of innovative medical technologies that challenge the traditional US regulatory scheme to consider the future of medical device regulation.

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