Devicemakers are asking for more incentives and flexible standards as the FDA explores ways to encourage the development of devices to treat rare diseases.
Reports of life-threatening air or gas embolism occurring during or immediately after application of hemostatic drug or biological products.
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Pilot Program for Medical ProductsJuly 9, 2010 5:31 am | by U.S. Food & Drug Administration | News | Comments
The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the agency.
Herbal product, sold as weight loss supplement, contains unlisted active pharmaceutical ingredients. Risk of serious side effects, especially in those with heart conditions.
Qualaquin (quinine sulfate): New Risk Evaluation and Mitigation Strategy - Risk of serious hematological reactionsJuly 8, 2010 10:31 am | by U.S. Food & Drug Administration | News | Comments
New Risk Management Plan. Reports of serious side effects in patients using Qualaquin "off-label" for night time leg cramps.
These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for January 2010
Federal Register: Guidance for Humanitarian Device Exemption Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff; Humanitarian...July 8, 2010 7:31 am | by U.S. Food & Drug Administration | News | Comments
This guidance answers commonly asked questions about Humanitarian Use Devices (HUDs) and applications for HDEs.
Reversing course on a new law aimed at diminishing the influence on doctors of pharmaceutical and medical device companies, the House on Wednesday voted to strike the so-called gift ban law, which critics say has hurt commerce in the medical and restaurant industries.
Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and Food and Drug Administration Staff - Humanitarian Device Exemption (HDE) Regulation: ...July 8, 2010 5:32 am | by U.S. Food & Drug Administration | News | Comments
This guidance document answers commonly asked questions about Humanitarian Use Devices (HUDs) and applications for Humanitarian Device Exemption (HDE) authorized by section 510(m)(2) of the Federal Food, Drug, and Cosmetic Act (the Act). This guidance doc
Labeling, Approval Order, and Summary of Safety and Effectiveness for Implantable Miniature Telescope? (P050034).
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CDRH Forum for International Medical Device Regulatory Authorities - Advanced Session, September 13-15, 2010July 6, 2010 7:34 am | by U.S. Food & Drug Administration | News | Comments
CDRH is pleased to announce an advanced session of the CDRH Forum for International Medical Device Regulatory Authorities scheduled for September 13-15, 2010. The CDRH Forum is established for the exchange of medical device regulatory information...
The firm received increasing numbers of complaints for false negative MRSA results. False negative could result in incorrect treatment or delay of care for patients with MRSA infection.
LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors by Physio-Control Inc.: Class I Recall Due To Power Supply Failure(2)July 2, 2010 11:31 am | by U.S. Food & Drug Administration | News | Comments
A power supply assembly failure can result in the inability to deliver defibrillation therapy.
Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications.July 2, 2010 5:31 am | by U.S. Food & Drug Administration | News | Comments
The FDA is publishing a list of premarket approval applications (PMAs) that have been approved. This ist is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency?s...
FDA learns of problems with medical devices in different ways. Most often, a firm will notify its customers and FDA that it is issuing a recall. At other times, FDA's analysis of medical device reports will indicate a greater than expected failure rate...
CDRH is looking forward to a day when it can exchange device information with trusted regulatory authorities in other countries using a harmonized inspection standard.
The FDA’s foreign posts are working more with regulators and industry to improve the safety of products made overseas.
By Jeff Shuren, M.D., J.D., Director of FDA's Center for Devices and Radiological Health.
Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval ApplicationsJune 24, 2010 6:32 am | by U.S. Food & Drug Administration | News | Comments
This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.
Federal Register: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of MeetingJune 24, 2010 6:31 am | by U.S. Food & Drug Administration | News | Comments
On August 26, 2010, the committee will discuss, make recommendations, and vote on premarket approval application for MelaFind, sponsored by MELA Sciences, Inc. MelaFind is a non-invasive computer vision system intended to assist in the evaluation of...
Drug failed to demonstrate clinical benefit to patients enrolled in trials.
Product marketed as a dietary supplement for sexual enhancement contains the drug ingredient hydroxythiohomosildenafil, a chemical that may interact with prescription nitrates, and cause dangerously low blood pressure.
Recurring complaints of leaking packages of natural collagen vascular grafts have resulted in a warning letter to Artegraft that cites a number of good manufacturing (GMP) problems related to the leaks.
Although Optovue is taking corrective action to bring a normative database used with its RTVue optical coherence tomography into compliance, it received a warning letter that notes the effectiveness of the corrections can’t be fully reviewed and evaluated because they are ongoing.