Neurosurgical materials and devices

✓ 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.

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Treatment of protruded lumbar intervertebral discs with chymopapain (Discase)

Journal of Neurosurgery ◽

10.3171/jns.1973.39.2.0203 ◽

1973 ◽

Vol 39 (2) ◽

pp. 203-208 ◽

Cited By ~ 31

Author(s):

Dwight Parkinson ◽

Christopher Shields

Keyword(s):

Intervertebral Disc ◽

Drug Administration ◽

Food And Drug Administration ◽

Intervertebral Discs ◽

Intervertebral Disc Disease ◽

Disc Disease ◽

Chemical Action ◽

Content Type ◽

Fine Print

✓ Thirty-three intervertebral disc patients who otherwise would have been subjected to surgery were treated by injection with chymopapain. The pharmacology, toxicology, physiology, immunology, and chemical action of this enzyme, which specifically reacts with chondromucoproteins, are discussed. Results indicate that this method, although still experimental and unapproved by the U. S. Food and Drug Administration, may become a useful addition to the surgeon's armamentarium in the treatment of intervertebral disc disease.

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

Journal of Pharmaceutical Research International ◽

10.9734/jpri/2021/v33i53a33634 ◽

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.

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

Journal of Oncology Practice ◽

10.1200/jop.2011.000290 ◽

2012 ◽

Vol 8 (1) ◽

pp. 53-56 ◽

Cited By ~ 4

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.

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

Radiology ◽

10.1148/radiology.205.1.9314953 ◽

1997 ◽

Vol 205 (1) ◽

pp. 10-18 ◽

Cited By ~ 10

Author(s):

L H Monsein

Keyword(s):

Medical Device ◽

Drug Administration ◽

Medical Devices ◽

Food And Drug Administration ◽

The U.S ◽

Medical Device Regulation

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

Otolaryngology ◽

10.1177/019459987908700109 ◽

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.

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Wyeth v. Levine: Challenging Implied Pre-emption for drugs

The Journal of Law Medicine & Ethics ◽

10.1017/s1073110500026516 ◽

2009 ◽

Vol 37 (3) ◽

pp. 527-530

Author(s):

Pooja Nair

Keyword(s):

Supreme Court ◽

Drug Administration ◽

Medical Devices ◽

Food And Drug Administration ◽

State Law ◽

Drug Labeling ◽

The Supreme Court ◽

Premarket Approval ◽

Tort Claims

In March 2009, the Supreme Court held in Wyeth v. Levine that federal drug labeling laws do not pre-empt state tort claims against drug manufacturers. The decision surprised many Court watchers, coming on the heels of a 2008 decision, Riegel v. Medtronic, in which the Court found that the Food, Drug, and Cosmetic Act (FDCA) does pre-empt state-law claims for injuries caused by medical devices that received premarket approval from the Food and Drug Administration. Wyeth dealt an immediate and surprising blow to the pharmaceutical industry’s principal strategy for avoiding tort lawsuits, but failed to clarify the Court’s overall pre-emption jurisprudence.

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Medical device’s regulation in South-East Asian countries: Current status and gap areas

Asian Journal of Pharmaceutical Research ◽

10.52711/2231-5691.2021.00032 ◽

2021 ◽

pp. 173-179

Author(s):

Vivekanandan Kalaiselvan ◽

Aishwarya G. ◽

Ashish Sharma

Keyword(s):

Adverse Event ◽

Medical Device ◽

Medical Devices ◽

East Asian ◽

Time Frame ◽

Adverse Event Reporting ◽

World Health ◽

Current Status ◽

Event Reporting ◽

Medical Device Regulation

As Medical device application in disease prevention, diagnosis or treatment is evolving to a greater extent; there is a need for regulation to monitor its quality, safety and efficacy. The present article attempts to study the medical device regulation available in eleven South-East Asian World Health Organization (WHO) member countries. The information searched from the available sources reveals that medical device regulation exists in seven countries. Most of the countries follow the International Organization for Standardization (ISO) 13485 for their quality standards in medical devices. Most countries also specified the time frame and authority to which adverse event is to be reported. Countries like India and Thailand have separate Adverse Event reporting forms for the medical device. The present study reveals that there is no separate web-based database for adverse event reporting of medical devices. Therefore, WHO South-East Asian Regulators Network (SEARN) under South East Regulatory Office (SERO) office may provide handholding support to these regions in developing a common software or tool for the management and analysis of signals arising from the adverse events.

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SUIT CLAIMS RESEARCH-HOSPITAL DOCTORS SUBMITTED PHONY BILLS TO GET U.S. FUNDS

PEDIATRICS ◽

10.1542/peds.96.5.a41 ◽

1995 ◽

Vol 96 (5) ◽

pp. A41-A41

Author(s):

J. F. L.

Keyword(s):

Drug Administration ◽

Medical Devices ◽

Food And Drug Administration ◽

Controversial Issue ◽

Criminal Investigation ◽

Research Hospital ◽

Medical Centers ◽

Cardiac Procedures ◽

Hospital Doctors ◽

The Government

Physicians at dozens of prominent research hospitals nationwide allegedly submitted phony bills and sometimes even falsified patients' records to obtain as much as $1 billion in federal payments for sophisticated, but still experimental, cardiac procedures, a newly unsealed whistleblower suit claims. The allegations of years of systematic fraud involving as many as 130 major medical centers nationwide, accusations that already have prompted a previously reported criminal investigation, are likely to shine a spotlight on the controversial issue of which cutting-edge devices and procedures currently are, or should be, eligible for Medicare or Medicaid claims. Existing regulations say that the government generally won't pay for treatment considered to be "experimental" or for the use of medical devices that haven't been formally approved by the Food and Drug Administration...

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