Regulatory
Class I Medical Device Recall: Symbiq One-Channel Infuser and Symbiq Two-Channel Infuser
July 15, 2010 12:32 pm | by U.S. Food & Drug Administration | News | CommentsThere is potential for the device to fail to detect air in line at the end of an infusion.
Angiotensin Receptor Blockers (ARBs): Ongoing Safety Review for Cancer Risk(2)
July 15, 2010 12:31 pm | by U.S. Food & Drug Administration | News | CommentsA recently published study suggested use of ARBs may be associated with a small increased risk of cancer.
Federal Register: Town Hall Discussion With the Director of the Center for Devices and Radiological Health and Other Senior Center Management
July 14, 2010 5:32 am | by U.S. Food & Drug Administration | News | CommentsThe purpose of this meeting is to present the CDRH Fiscal Year (FY) 2010 Priorities. In addition, FDA is interested in engaging in discussions about issues that are of importance to the medical device industry.
Coumadin 1 mg Tablet Blister Packs: Recall(2)
July 14, 2010 5:31 am | by U.S. Food & Drug Administration | News | CommentsSome tablets may not meet specification for isopropanol, which could affect therapeutic levels of the active ingredient.
Arava (leflunomide): Boxed Warning - Risk of Severe Liver Injury
July 13, 2010 9:31 pm | by U.S. Food & Drug Administration | News | CommentsWarning highlights the risk of severe liver injury and how this risk may be reduced.
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products
July 13, 2010 5:41 am | by U.S. Food & Drug Administration | News | CommentsThe FDA is announcing an opportunity for public comment on the proposed collection of certain information by the agency.
Federal Register: Oversight of Laboratory Developed Tests; Public Meeting; Change of Meeting Location
July 13, 2010 5:32 am | by U.S. Food & Drug Administration | News | CommentsThe public meeting will be held at The Marriott Inn & Conference Center, University of Maryland University College, 3501 University Blvd. E, Hyattsville, MD 20783.
Supreme Court Decision Could Help Protect Patents for Diagnostics
July 12, 2010 8:31 am | by U.S. Food & Drug Administration | News | CommentsDiagnostic companies seeking to patent a process or method used in product development may have an easier time doing so following a recent Supreme Court decision.
Industry: The FDA Can Do More to Speed Development of HDEs
July 12, 2010 8:31 am | by U.S. Food & Drug Administration | News | CommentsDevicemakers are asking for more incentives and flexible standards as the FDA explores ways to encourage the development of devices to treat rare diseases.
Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism
July 9, 2010 10:30 am | by U.S. Food & Drug Administration | News | CommentsReports 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 Products
July 9, 2010 5:31 am | by U.S. Food & Drug Administration | News | CommentsThe FDA is announcing an opportunity for public comment on the proposed collection of certain information by the agency.
Que She Herbal Supplement: Undeclared Drug Ingredients
July 8, 2010 1:31 pm | by U.S. Food & Drug Administration | News | CommentsHerbal 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 reactions
July 8, 2010 10:31 am | by U.S. Food & Drug Administration | News | CommentsNew Risk Management Plan. Reports of serious side effects in patients using Qualaquin "off-label" for night time leg cramps.
PMA Final Decisions for May 2010
July 8, 2010 7:37 am | by U.S. Food & Drug Administration | News | CommentsThese 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 | CommentsThis guidance answers commonly asked questions about Humanitarian Use Devices (HUDs) and applications for HDEs.
House strikes gift ban in effort to boost business
July 8, 2010 5:38 am | by Mass High Tech: The Journal of New England Technology | News | CommentsReversing 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 | CommentsThis 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
Summary Information for: Implantable Miniature Telescope?
July 7, 2010 10:31 am | by U.S. Food & Drug Administration | News | CommentsLabeling, Approval Order, and Summary of Safety and Effectiveness for Implantable Miniature Telescope? (P050034).
510(k) Final Decisions - June 2010(2)
July 7, 2010 10:31 am | by U.S. Food & Drug Administration | News | CommentsPage Last Updated: 07/07/2010 Note: If you need help accessing information in different file formats, see Instructions for Downlo
CDRH Forum for International Medical Device Regulatory Authorities - Advanced Session, September 13-15, 2010
July 6, 2010 7:34 am | by U.S. Food & Drug Administration | News | CommentsCDRH 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...
Cepheid Xpert MRSA-SA Blood Culture Assay for Use with the GeneXpert Dx System: Class I Recall
July 2, 2010 8:31 pm | by U.S. Food & Drug Administration | News | CommentsThe 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 | CommentsA 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 | CommentsThe 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...
Health Hazard Evaluations (HHEs) and Health Risk Assessments (HRAs)
July 1, 2010 1:31 pm | by U.S. Food & Drug Administration | News | CommentsFDA 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...
Harmonized Inspection Standard in CDRH's Future, Official Says
June 25, 2010 4:31 pm | by U.S. Food & Drug Administration | News | CommentsCDRH is looking forward to a day when it can exchange device information with trusted regulatory authorities in other countries using a harmonized inspection standard.
