PubMed Health⌕ Search

SEARCH · PubMed Health

Results for “Device Approval”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 469 records · Page 26Linked to original sources
PubMed2004

Intestinal adhesion to the abdominal wall after skin closure with octylcyanoacrylate.

Octylcyanoacrylate tissue adhesive glue is a wound closure device recently approved by the U.S. Food and Drug Administration. Few complications have been reported regarding the liquid adhesive entering the wound. The following report involves a patient who developed intestinal occlusion secondary to octylcyanoacrylate used for skin closure in laparoscopic surgery.

Abdominal Wall↗
PubMed2003

Production of high-quality marketing applications: strategies for biotechnology companies working with contract research organizations.

Many biotechnology and pharmaceutical companies use clinical research organizations (CROs) to assist in the writing and preparation of clinical documents intended for submission to health authorities. Start-up companies often require the expertise of a CRO to prepare their first regulatory documents. Larger or more experienced companies often require CRO staff to assist at times of multiple simultaneous submissions. The timely production of high-quality new drug marketing applications requires close collaborations between the drug company and the CRO. The views of both CRO and industry in ensuring best practices are discussed.

Biotechnology↗
PubMed2005

Food and Drug Administration regulation of in vitro diagnostic devices.

The Food and Drug Administration regulates the sale and distribution of laboratory devices under a statutory and regulatory framework that is unfamiliar to most clinical laboratory scientists. In this article we briefly describe the criteria that are used to classify and review in vitro diagnostic devices. We discuss the similarities and differences between devices that are not subject to premarket review, and those that are required to undergo either a premarket application or premarket notification [510(k)] pathway. We then discuss the methods that the Food and Drug Administration uses to assess the performance of in vitro diagnostic devices in the marketplace as a component of the total life cycle approach to medical device regulation.

Device Approval↗
PubMed2003

What does it take? A case study of radical change toward patient safety.

BACKGROUND: Adopting a human factors engineering approach to patient safety requires a radical behavioral shift from "blame and shame," which emphasizes further training, to systems thinking, which also emphasizes improved system design. A medical device manufacturer appeared to initiate this radical shift after exhibiting the traditional approach for years. METHODOLOGY: The research focused on a patient-controlled analgesia device. A qualitative case study methodology was used to study events in the period from the device's introduction (1988) until the start of the behavioral change (May 2001). Data on 50 relevant events were analyzed. The tabular summary was analyzed for evidence of the prerequisites predicted by punctuated equilibrium theory, and the graphical time line was analyzed for evidence of vertical alignment across levels. RESULTS: Radical behavioral change was preceded by a critical 9.5-month period with three characteristics: new corporate leadership, perceived poor corporate performance, and aligned disruptions occurring within a relatively short time at almost every level in the external environment in which the company operated. DISCUSSION: These findings are consistent with punctuated equilibrium theory, according to which organizations can experience long periods of resistance to change followed by fast revolutionary change (approximately two years). The findings also have implications for when and how to introduce patient safety policy interventions to "tilt the playing field" and thereby increase the likelihood that such reforms will succeed.

Analgesia, Patient-Controlled↗
PubMedDate not supplied

Incorporating drugs and devices into emergency medical services systems.

The proliferation of new medical technology and pharmacology forces the medical community to ensure the efficacy and safety of new drugs and devices before their use in patient care. Although traditional medical practices have a fairly consistent means to achieve this end, prehospital medical practice often does not. In addition, it often appears that the emergency medical services marketplace does not always follow conventional supply/demand and cost/quality paradigms. This article describes a process implemented in Pennsylvania to standardize the mechanism by which new drugs and devices are introduced into prehospital medical practice.

Device Approval↗
PubMedDate not supplied

Introduction to the Food and Drug Administration (FDA) regulatory process.

FDA oversight of medical devices, including in vitro diagnostic devices (IVDs or laboratory tests), in the United States was a direct result of the passage of the Medical Device Amendments of 1976. This law introduced a series of general controls for medical devices including registration and listing, requirements for production using good manufacturing practices, and requirements for post-market reporting of device failures. This produced for the first time a menu of laboratory tests on the market, a system to ensure these were produced consistently over time, and a mechanism for FDA to identify problems with device use and to work with companies to ensure corrective action. This law also introduced the requirement for premarket review of new versions of old devices and of fundamentally new medical devices.

Animals↗