Is Remote Human Factors Testing an Acceptable Approach for Human Factors Validation

2021 ◽  
Vol 10 (1) ◽  
pp. 152-156
Author(s):  
Anil R. Kumar ◽  
Kevin Cluff ◽  
Tim McLeroy
Keyword(s):  
Human Factors ◽  
Drug Administration ◽  
Medical Devices ◽  
Food And Drug Administration ◽  
Laboratory Research ◽  
Fda Approval ◽  
Wide Range ◽  
Medical Device Manufacturers ◽  
Controlled Environments ◽  
To Receive

Human factors (HF) validation of medical devices is vital for approval of use by the Food and Drug Administration (FDA). Historically, validation testing of medical devices has taken place within laboratory-controlled environments where conditions are controlled, and testing is executed in accordance with similar circumstance. Due to the COVID-19 pandemic, laboratory research has decreased in a wide range of disciplines or in instances continued with masks and many other COVID mitigations. As a result, medical device manufacturers who need to provide human factors validation to receive U.S. Food and Drug Administration (FDA) approval were impacted. Remote usability testing, while a fairly new phenomenon for physical devices, affords the ability to functionally test a product within naturalistic environments that are indistinguishable from the settings in which they would be used (e.g. the user’s home). However, published literature to support whether remote HF testing could potentially be an acceptable approach is rare. The objective of this study is to replicate the objectives and structure of an original in-person study, which was conducted using migraine patients who performed one unaided simulated injection using a 2-step autoinjector. The original methodology has been modified to adapt to the remote testing. This paper reports the procedures that has been developed for this ongoing endeavor.

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.

Biosimilar epoetin for cancer and chemotherapy-induced anaemia in the US

2021 ◽  
Vol 10 (3) ◽  
pp. 122-122
Author(s):  
Charles L Bennett
Keyword(s):  
Advisory Committee ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Pharmacokinetics And Pharmacodynamics ◽  
Safety And Efficacy ◽  
Biological Drug ◽  
Drug Products ◽  
Fda Approval ◽  
The Us ◽  
Approval Letter

Biosimilars are biological drug products that are highly similar to reference products in analytic features, pharmacokinetics and pharmacodynamics, immunogenicity, safety and efficacy. Biosimilar epoetin received US Food and Drug Administration (FDA) approval in 2018 [1]. The manufacturer received an FDA non-approval letter in 2017, despite receiving a favourable review by the FDA’s Oncologic Drugs Advisory Committee (ODAC) and an FDA non-approval letter in 2015 for an earlier formulation.

Efficacy, Safety, and Regulatory Approval of Food and Drug Administration–Designated Breakthrough and Nonbreakthrough Cancer Medicines

2018 ◽  
Vol 36 (18) ◽  
pp. 1805-1812 ◽  
Author(s):  
Thomas J. Hwang ◽  
Jessica M. Franklin ◽  
Christopher T. Chen ◽  
Julie C. Lauffenburger ◽  
Bishal Gyawali ◽  
...  
Keyword(s):  
Adverse Events ◽  
Solid Tumors ◽  
Drug Administration ◽  
Mechanism Of Action ◽  
Food And Drug Administration ◽  
Progression Free Survival ◽  
Cancer Drugs ◽  
Serious Adverse Events ◽  
Hazard Ratios ◽  
Fda Approval

Purpose The breakthrough therapy program was established in 2012 to expedite the development and review of new medicines. We evaluated the times to approval, efficacy, and safety of breakthrough-designated versus non–breakthrough-designated cancer drugs approved by the US Food and Drug Administration (FDA). Methods We studied all new cancer drugs approved by the FDA between January 2012 and December 2017. Regulatory and therapeutic characteristics (time to FDA approval, pivotal trial efficacy end point, novelty of mechanism of action) were compared between breakthrough-designated and non–breakthrough-designated cancer drugs. Random-effects meta-regression was used to assess the association between breakthrough therapy designation and hazard ratios for progression-free survival (PFS), response rates (RRs) for solid tumors, serious adverse events, and deaths not attributed to disease progression. Results Between 2012 and 2017, the FDA approved 58 new cancer drugs, 25 (43%) of which received breakthrough therapy designation. The median time to first FDA approval was 5.2 years for breakthrough-designated drugs versus 7.1 years for non–breakthrough-designated drugs (difference, 1.9 years; P = .01). There were no statistically significant differences between breakthrough-designated and non–breakthrough-designated drugs in median PFS gains (8.6 v 4.0 months; P = .11), hazard ratios for PFS (0.43 v 0.51; P = .28), or RRs for solid tumors (37% v 39%; P = .74). Breakthrough therapy–designated drugs were not more likely to act via a novel mechanism of action (36% v 39%; P = 1.00). Rates of deaths (6% v 4%; P = .99) and serious adverse events (38% v 36%; P = 0.93) were also similar in breakthrough-designated and non–breakthrough-designated drugs. Conclusion Breakthrough-designated cancer drugs were associated with faster times to approval, but there was no evidence that these drugs provide improvements in safety or novelty; nor was there a statistically significant efficacy advantage when compared with non–breakthrough-designated drugs.

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