On November 8 and 9, 2010, the Committee will hear and discuss developments in FDA's ongoing communications programs, such as the challenges of effectively communicating with patients and caregivers about appropriate use of medical devices when...
New information warns about increased risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, stroke) in men receiving these medications for the treatment of prostate cancer.
These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for September 2010.
The FDA is extending to November 1, 2010, the comment period for the notice that appeared in the Federal Register of August 13, 2010 (75 FR 49502).
Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Medical Devices a...October 18, 2010 5:30 am | by U.S. Food & Drug Administration | News | Comments
The FDA is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Excelsior Medical 5 ml Fill in 6 cc Prefilled Saline Flush Syringes: Recall - Potential Loss of SterilityOctober 15, 2010 12:31 pm | by U.S. Food & Drug Administration | News | Comments
Exposure to syringes with a sterility issue could result in systemic infection, which may lead to serious injury and/or death.
CareFusion Corporation Alaris PC Units (Model 8015): Recall - Potential for Delay or Interruption of TherapyOctober 15, 2010 11:30 am | by U.S. Food & Drug Administration | News | Comments
Hardware communication error may lead to serious injury or death.
Freedom of Information Act documents, in Adobe PDF format.
Reason for Recall: Under certain wireless network conditions, a communication error can occur, which freezes the PC Unit screen. This error may result in a delay of therapy and inability to make programming changes to current infusions...
Consumers advised to avoid OTC chelation products because of the potential for serious harm associated with their use, including dehydration, kidney failure, and death.
Risk of atypical fractures of the thigh, known as subtrochanteric and diaphyseal femur fractures, in patients who take bisphosphonates for osteoporosis.
Federal Register: Innovations in Technology for the Treatment of Diabetes: Clinical Development of the Artificial Pancreas (an Autonomous System); Public WorkshopOctober 13, 2010 6:30 am | by U.S. Food & Drug Administration | News | Comments
The topics to be discussed are the current state of device systems for autonomous systems for the treatment of diabetes mellitus, the challenges in developing this expert system using existing technology, a discussion of the clinical expectations and...
Specific bottles of Lipitor 40 mg recalled due to a small number of reports of an uncharacteristic odor.
FDA is issuing this guidance document to recommend that manufacturers include their Uniform Resource Locator (URL) on their electronic product labels in addition to the requirements under 21 CFR 1010.3(a)(1) and (2) that manufacturers include their full..
Sen. Chuck Grassley (R-Iowa) is pressuring Congress to increase government oversight of group purchasing organizations (GPOs), which, through their purchasing contracts, control devicemaker access to their member hospitals.
Old claims of coercion at CDRH are being tackled once again — at CDRH itself and in two reviews at HHS’ Office of Inspector General (OIG).
Abbott RealTime HBV is a laboratory test kit that measures the amount of hepatitis B viral DNA in the blood of an individual infected by the hepatitis B virus (HBV). Viral DNA is the genetic material from the hepatitis B virus.
Labeling, Approval Order, and Summary of Safety and Effectiveness for Abbott RealTime HBV Assay (P080026).
Search the CDRH Inspections Database by various fields, such as company name, location, medical specialty, etc.
The CDRH Inspections Database1 provides information about medical device inspections that were the responsibility of CDRH from 2008 to the present.
CPSC and FDA Warn Against Using Infant Sleep Positioners Because of Suffocation Risk: Initial CommunicationSeptember 29, 2010 8:31 am | by U.S. Food & Drug Administration | News | Comments
The FDA and the CPSC are aware of 12 infant deaths in the past 13 years associated with the use of infant sleep positioners. Deaths occurred after the baby rolled from its back onto its stomach and became trapped and suffocated between the device and...
Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological AssaysSeptember 28, 2010 1:31 pm | by U.S. Food & Drug Administration | News | Comments
This special controls guidance document was developed to support the reclassification of the herpes simplex virus types 1 and 2 (HSV 1 and 2) serological assays into class II. HSV serological assays are devices that consist of antigens and antisera...
Federal Register: Microbiology Devices; Reclassification of Herpes Simplex Virus Types 1 and 2 Serological Assays; Confirmation of Effective Date.September 28, 2010 1:31 pm | by U.S. Food & Drug Administration | News | Comments
The FDA is is confirming the effective date of December 7, 2009, for the direct final rule that appeared in the Federal Register of August 25, 2009 (74 FR 42773). The direct final rule corrects the regulation classifying herpes simplex virus (HSV)...
Federal Register: Immunology and Microbiology Devices; Reclassification of Herpes Simplex Virus Serological Assay Device.September 28, 2010 1:31 pm | by U.S. Food & Drug Administration | News | Comments
The FDA is proposing to amend the special controls for the herpes simplex virus (HSV) serologicalassay device type, which is classified as class II (special controls). These device types are devices that consist of antigens and antisera used in various...
During cystoscopy and incision of a ureterocele in a 2-month old, the insulation slipped off the sheath and slid over the tip of the catheter exposing the hook electrode. Fortunately, the 2-month old was not injured. It was discovered that improper...