Regulatory
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.
Increased Collaboration Goal of FDA & #8217;s 10 Foreign Posts
June 25, 2010 4:30 pm | by U.S. Food & Drug Administration | News | CommentsThe FDA’s foreign posts are working more with regulators and industry to improve the safety of products made overseas.
FDA's Role in Fostering the Development of Better Medical Devices
June 24, 2010 6:32 am | by U.S. Food & Drug Administration | News | CommentsBy 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 Applications
June 24, 2010 6:32 am | by U.S. Food & Drug Administration | News | CommentsThis 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 Meeting
June 24, 2010 6:31 am | by U.S. Food & Drug Administration | News | CommentsOn 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...
Mylotarg (gemtuzumab ozogamicin): Market Withdrawal
June 21, 2010 1:31 pm | by U.S. Food & Drug Administration | News | CommentsDrug failed to demonstrate clinical benefit to patients enrolled in trials.
Magic Power Coffee: Undeclared Drug Ingredient
June 21, 2010 6:30 am | by U.S. Food & Drug Administration | News | CommentsProduct 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.
Leaking Packaging, GMP Issues Result in Artegraft Warning
June 18, 2010 4:31 pm | by U.S. Food & Drug Administration | News | CommentsRecurring 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.
FDA Acknowledges Corrections, Sends Optovue Warning Letter
June 18, 2010 4:31 pm | by U.S. Food & Drug Administration | News | CommentsAlthough 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.
