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PubMedDate not supplied

Complications and outcomes of one-step low-profile gastrostomy devices for long-term enteral feeding in dogs and cats.

Sixteen dogs and cats with a variety of primary diseases were retrospectively evaluated following endoscopic placement of a one-step low-profile gastrostomy device. Overall, the devices were well tolerated, with most complications being minor in nature. Complications included bloody or purulent peristomal discharge, peristomal swelling, peristomal inflammation, discomfort associated with the device, leaking through the device, chewing at the device, premature removal of the device, peritonitis, and aspiration pneumonia. Dogs survived for up to 2241 days, and cats survived for up to 593 days after initial device placement. The median survival time after device insertion for dogs was 89 days, and for cats it was 87 days.

Animals↗
PubMed1998

Medical devices; reports of corrections and removals; lift of stay of effective date--FDA. Final rule; lift of stay of effective date.

The Food and Drug Administration (FDA) is lifting a stay of the effective date of certain provisions in a final rule on establishing procedures for submission of reports of corrections and removals of medical devices. The Office of Management and Budget (OMB) has approved the collection of information requirements contained in the final rule.

Device Approval↗
PubMed1998

Medical devices; reports of corrections and removals--FDA. Direct final rule.

The Food and Drug Administration (FDA) is amending its regulations that govern reports of corrections and removals of medical devices to eliminate the requirement for distributors to make such reports. The amendments are being made to implement provisions of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDA is publishing these amendments in accordance with its direct final rule procedures. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comment and withdraws the direct final rule.

Device Approval↗
PubMed1998

Medical devices; reports of corrections and removals; companion to direct final rule--FDA. Proposed rule.

The Food and Drug Administration (FDA) is proposing to amend its regulations governing reports of corrections and removal of medical devices to eliminate the requirement for distributors to make such reports. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. The amendments are being made to implement provisions of the Federal Food, Drug and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). This companion proposed rule is issued under FDAMA and the act as amended.

Device Approval↗
PubMed1998

Medical devices: reports of corrections and removals; delay of effective data--FDA. Direct final rule; delay of effective date.

The Food and Drug Administration (FDA) published in the Federal Register of August 7, 1998 (63 FR 42229), a direct final rule. The direct final rule notified the public of FDA's intention to amend the regulations that govern reports of corrections and removals of medical devices to eliminate the requirement for distributors to make such reports. This document delays the effective date of the direct final rule.

Device Approval↗
PubMed1990

Insertion and removal of intrauterine devices.

Although intrauterine contraceptive devices are becoming less commonly used, all general practitioners need to be able to counsel patients about their use. A practical outline of the recommended regimens is provided in this article.

Family Practice↗