Regulatory Challenges for Medical Devices and Drugs Under the China Food and Drug Administration

2015 ◽  
pp. 91-106
Author(s):  
Gordon B. Schatz
Keyword(s):  
Drug Administration ◽  
Medical Devices ◽  
Food And Drug Administration ◽  
Regulatory Challenges

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

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.

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

PEDIATRICS ◽  
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...

Fatal and serious complications associated with cosmetic suction lipectomy

2002 ◽  
Vol 10 (2) ◽  
pp. 69-74 ◽  
Author(s):  
S Lori Brown ◽  
Janos T Bacsanyi ◽  
Sherry L Purvis-Wynn
Keyword(s):  
Drug Administration ◽  
Medical Devices ◽  
Cosmetic Surgery ◽  
Medical Literature ◽  
Food And Drug Administration ◽  
The United States ◽  
Physician Training ◽  
Fatty Tissue ◽  
Potential Risk Factors ◽  
Causes Of Deaths

Liposuction is the most commonly performed cosmetic surgery procedure in the United States. The medical devices and drugs used in the performance of liposuction are regulated by the Food and Drug Administration. Serious liposuction-related complications, including death, are reported in the literature. A review of reported complications and causes of deaths related to liposuction is presented. Prospective studies examining potential risk factors for complications, such as amount of fatty tissue removed and extent of body surface area affected, concomitant surgeries, method of anesthesia, impact of physician training and site of surgery, are needed to clarify the risks involved in liposuction. Studies are required to establish the risk-benefit profile of this procedure to allow patients and physicians to be adequately informed. Adverse events have been under-reported to the Food and Drug Administration despite numerous reports in the medical literature of serious complications associated with the use of medical devices in the performance of liposuction.

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.

Off-Label Use and Prescribing What Does It Mean for the Foot and Ankle Surgeon?

2010 ◽  
Vol 3 (5) ◽  
pp. 303-306
Author(s):  
Christopher F. Hyer
Keyword(s):  
Drug Administration ◽  
Medical Devices ◽  
Clinical Studies ◽  
Food And Drug Administration ◽  
Good Thing ◽  
Foot And Ankle ◽  
Off Label Use ◽  
Off Label ◽  
Practice Of Medicine ◽  
Indications For Use

Drugs and medical devices obtain specific on-label indications for use by the Food and Drug Administration. Physicians are able to use such devices and drugs off label as part of the practice of medicine, but is this is good thing? This edition of In the Profession examines what it means to be off label in terms of regulations, clinical studies, industry marketing, and common areas of use.

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