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68 Resources for

fda and medical device

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US regulation of advertising and promotional materials: medical device manufacturers do not always properly control the development of new or modified promotional labelling and advertising materials. This lack of control can lead to unexpected regulatory: FDA authority With the exception of products that are exempt from the regulatory submission process, manufacturers marketing medical devices in the United States US must provide proposed labelling to the Food and Drug Administration FDA. FDA authority...; Tags: advertisement, compliance, FDA, medical device, regulation, Web site; Research articles 2006-05-01
FDA Amends Postmarket Program for Medical Devices: The U.S. Food and Drug Administration FDA announced on November 10 its action plan for strengthening its monitoring of the safety of medical devices after they reach the marketplace. "Many of today's medical devices are smaller and more complex thaThe U.S. Food and Drug Administration FDA announced on November 10...; Tags: action plan, FDA, medical device; Research articles 2007-01-01
Underwriters Laboratories Extends Two-Week Turnaround Guarantee on FDA 510(k) Third Party Submissions for Medical Device Conformance Testing: Underwriters Laboratories UL, a world leader in product safety testing, certification and management system registrations, recently announced the extension of its two-week guaranteed turnaround for medical device conformance testing under the U.S. Food and Drug Administration FDA 510k Third Party program. Earlier this year, UL announced its position as...; Tags: FDA, medical device; Research articles 2007-04-19
Biophan Technologies Announces Research and Development Partnership with FDA to Study MRI Safety; Collaboration to Help Establish Testing Guidelines and Standards for Evaluating the Safety of Implanted Medical Devices: ROCHESTER, N.Y. -- Biophan Technologies, Inc. (OTCBB: BIPH; FWB: BTN), a developer of next-generation medical technology, today announced that it has entered into a research partnership with the US Food and Drug Administration FDA to help improve patient safety in Magnetic Resonance Imaging MRI environments.; Tags: collaboration, FDA, medical device, R&D; Research articles 2006-05-02
Sparta Systems Announces Software for Electronic Submission of Medical Device Reports to Food and Drug Administration (FDA): To: TECHNOLOGY EDITORSTo: TECHNOLOGY EDITORS; Tags: FDA, medical device, software, Technology; Research articles 2007-02-21

FDA: risk disclosure.(Food and Drug Administration seeks comment on guidance for drug makers)(Brief Article): FDA: Risk disclosure. The Food and Drug Administration reopens a request for comment on guidance for manufacturers of prescription drugs and medical devices on disclosing risks (OAR, Feb 13, p. 48). There are actually three pieces of ... FDA: Risk disclosure. The Food and...; Tags: FDA, medical device; Research articles 2004-06-04
Medical device makers find solution to FDA demands: In the medical device industry, efficiently meeting requirements of the Food and Drug Administration is a key to business success, and Product Lifecycle Management PLM technology supports FDA compliance integrity by providing comprehensive content to support management decisions across the organization and the individual functional groups. PLM achieves this by...; Tags: FDA, medical device; Research articles 2007-12-01
Medical.: FDAnews (Washington, D.C.) has released "Roadmap to FDA Laws and Regulations: Medical Devices and Radiation Emitting Products," a management report that includes definitions and classifications of medical devices, relevant guidance for FDA FDAnews (Washington, D.C.) has released "Roadmap to FDA Laws and Regulations: Medical...; Tags: FDA, medical device; Research articles 2005-12-01
Hospitals Urge FDA to Require Bar Codes on Medical Devices; Bar Coding of Drugs, Biologicals, Blood Products and Devices Seen as Tool for Improved Patient Safety, Care Quality and More Efficient Delivery: WASHINGTON -- On the heels of an internal report critical of the Food and Drug Administration's post-market safety surveillance of medical devices--as well as its oversight of the manufacturers, themselves--hospital groups are urging the agency to act. They have appealed to the FDA to take swift action on a February...; Tags: FDA, medical device, patient, tool; Research articles 2005-05-09
FDA wants reform of medical device ads.(Capital Watch)(Food and Drug Administration)(Brief Article): Hearing aids and other medical devices may fail under the same broadcast advertising standards as pharmaceuticals. Under a proposal by the Food and Drug Administration, advertisers would be encouraged to disclose the most serious and common risks a Hearing aids and other medical devices...; Tags: advertisement, FDA, medical device, pharmaceutical company, risk; Research articles 2004-02-16
Update: Underwriters Laboratories Extends Two-Week Turnaround Guarantee on FDA 510(k) Third Party Submissions for Medical Device Conformance Testing: Underwriters Laboratories UL, a world leader in product safety testing, certification and management system registrations, recently announced the extension of its two-week guaranteed turnaround for UL's reviews under the U.S. Food and Drug Administration FDA Third Party 510k review program. Earlier this year, UL announced its position as the...; Tags: FDA, medical device; Research articles 2007-04-20
FDA device-approval time to be reduced: The FDA announced on August 5 a new goal for reducing the time during which medical devices remain under review by the agency. In part as a result of additional resources provided under the Medical Device User Fee and Modernization Act MDUFMA, the FDA wThe FDA announced on August 5...; Tags: agency, FDA, medical device; Research articles 2003-10-01
FDA Clears Cook's Surgisis AFP Fistula Plug as First Medical Device for Fistula Repair: WEST LAFAYETTE, Ind. -- The U.S. Food and Drug Administration has cleared the SurgisisR AFPTM Fistula Plug as the first and only surgical device for repair of fistulas, Cook Biotech Incorporated announced today.; Tags: FDA, medical device; Research articles 2005-04-28
Call for labelling of PVC medical devices. (Environmental Issues).: A US pressure group called Health Care Without Harm says that the US Food and Drug Administration FDA has not gone far enough in its warnings about medical PVC devices that incorporate phthalate-based plasticizers. A US pressure group called Health Care Without Harm says...; Tags: FDA, medical device; Research articles 2002-10-01
FDA pushes labeling of medical devices that contain DEHP.(Brief Article): THE FOOD and Drug Administration FDA is recommending that manufacturers label medical devices made with di-(2-ethylhexyl)phthalate DEHP, a chemical used to soften polyvinvyl chloride PVC plastic. The FDA'S (Iraft guidance also recommends THE FOOD and Drug Administration FDA is...; Tags: FDA, medical device; Research articles 2002-09-16
Quality in medical devices: Medical device manufacturers now have a guide through the complexities of the Food and Drug Administration's quality laws and a way of comparing them with international requirements. A new handbook, The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, written for manufacturers as well as FDA inspectors, uses...; Tags: FDA, medical device; Research articles 1997-02-01
FDA: More inspection coverage needed: > Hard on the heels of two major enforcement actions against Lilly and ScheringPlough, FDA, on March 8, told Congress that it will need to increase inspections of medical product manufacturers to ensure Americans have access to safe products. Testifying before the House Appropriations Subcommittee on Agriculture, acting principal Deputy...; Tags: FDA, medical device; Research articles 2001-05-01
AMA Asks FDA to Expedite DEHP Evaluation. (Markets).(risks of use of diethylhexyl phthalate in medical supplies)(Brief Article): THE AMERICAN Medical Association AMA asked the Food & Drag Administration FDA last week to expedite its evaluation of ways to address the potential risks that may be associated with the use of DEHP-containing medical devices used in certain THE AMERICAN Medical Association AMA...; Tags: American Medical Association, FDA, medical device, medical supplies; Research articles 2001-12-10
Medical Device Technologies Inc. submits follow-up 510k application to FDA for automated brush biopsy device used in diagnosis of bladder cancer: SAN DIEGO--BUSINESS WIRE--Jan. 14, 1997--Medical Device Technologies Inc. (NASDAQ:MEDD, MEDDP, MEDDW) Tuesday announced that the company has submitted a follow-up 510k application to the U.S. Food and Drug Administration FDA for design modifications to its Cell Recovery System CRS.; Tags: FDA, medical device; Research articles 1997-01-14
FDA allows leeches as medical devices; Westbury co. that sells them: A recent ruling by the Food and Drug Administration allowing a French company to market leeches as medical devices may not bring riches to Westbury-based Leeches USA Ltd., but it has shined a media spotlight on the company selling the annelids, or segmented worms.; Tags: FDA, medical device; Research articles 2004-07-16