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What's New: Devices & Radiology
Sep 08
Reason for Recall: The PTCA catheters may become separated during use in which fragments of the catheter may become lodged in coronary arteries. This may result in serious injuries, including death.
Sep 08
The FDA is reclassifying the device type, standard PTCA catheters, from class III (premarket approval) into class II (special controls). Cutting/scoring PTCA catheters remain in class III and continue to require PMAs.
Sep 08
This guidance document was developed as a special control to support the reclassification of certain Percutaneous Transluminal Coronary Angioplasty (PTCA) catheters into class II (special controls). The device is intended for balloon dilatation of a hemod
Sep 08
The guidance was developed as a special control to support the reclassification of PTCA catheters, other than cutting/scoring PTCA catheters, from class III (premarket approval) into class II (special controls).
Sep 07
The FDA has determined the regulatory review period for BRYAN CERVICAL DISC SYSTEM and is publishing this notice of that determination as required by law.
Sep 07
Innovation, Technology Transfer and Scientific Interchange: Leveraging Academic and FDA Collaborations to Resolve Unmet Public Health Needs
Sep 03
The FDA is is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the...
Sep 02
Eyeglasses and sunglasses (eyewear) that are intended to affect the structure or function of the body or intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, are devices...
Sep 02
The FDA is announcing the availability of the guidance entitled 'Impact-Resistant Lenses: Questions and Answers.' This guidance document answers manufacturer, importer, and consumer questions on impact-resistant lenses, including questions on test...
Sep 02
In the past, the ODE Annual Report included information from and about the ODE Review Divisions, our initiatives, and data analysis from the ODE Program Operations Staff (POS). The FY 09 Report only includes data from POS on our premarket review program.
Sep 01
The FDA is announcing an amendment to the notice of a public meeting on the reauthorization of the medical device user fee program. This meeting was announced in the Federal Register of August 13, 2010 (75 FR 49502). The amendment is being made to...
Sep 01
The FDA is correcting a notice that appeared in the Federal Register of August 23, 2010 (75 FR 51829). The notice announced the public workshop entitled 'Medical Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility...
Aug 27
The FDA has become aware of problems associated with the quality of mammograms performed at the Medisound, Inc. facility, located at 301 North John Young Parkway, Kissimmee, Florida 34741...
Aug 26
FDA has published a notice in the Federal Register requesting public comment on these reports. Please see Docket No. FDA-2010-N-0348, "Center for Devices and Radiological Health 510(k) Working Group Preliminary Report and Recommendations, and Task Force..
Aug 26
Huber needles are safety needles used on vascular access ports implanted in patients in need of repeated intravenous therapy. A "coring" Huber needle could damage the implanted port by removing silicone slivers from the access membrane...
Aug 26
Huber needles are used to access ports implanted under the skin of chronically ill patients for repeated access to veins for the withdrawal of blood and infusion of medication, nutritional solutions, blood products, and imaging solutions...
Aug 26
CDC and FDA have noted a progressive increase in the reports of bloodborne infection transmission over the past 10 to 15 years (primarily hepatitis B virus), resulting from the shared use of fingerstick and POC blood testing devices...
Aug 25
The FDA is proposing to require the filing of a PMA or a PDP for the following four class III preamendments devices: Ventricular bypass (assist) device; pacemaker repair or replacement material; female condom; and transilluminator for breast evaluation.
Aug 23
The public workshop on FDA's clinical trial requirements is designed to aid the clinical research professional's understanding of the mission, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. The program will
Aug 23
This guidance document is an addendum to a special control guidance that supports the classification of the Contact Lens Care Products as class II (special controls). This draft guidance will be issued in conjunction with a Federal Register notice...
Aug 23
As men age, the prostate enlarges over time obstructing the prostatic urethra and interfering with sphincter function. The resulting condition, known as benign prostatic hyperplasia (BPH), is associated with decreased peak urinary flow rate...
Aug 23
Reason for Recall: A component within the pressure switch, which monitors when the drug supply should be replaced, may tear. Risks to the patient may include interruption of drug flow due to an empty cylinder, and/or the time taken to switch to a...
Aug 23
These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for July 2010.
Aug 23
The purpose of this workshop is to obtain information on the safety and effectiveness of medical devices utilizing nanotechnology. Specifically, FDA would like public input on manufacturing, characterization, and biocompatibility evaluation of medical...
Aug 23
The purpose of this workshop is to obtain information on manufacturing, characterization, and biocompatibility evaluation of medical devices containing or utilizing nanomaterials and nanostructures, including diagnostics. FDA is seeking input on these...
Aug 20
The purpose of the public workshop is to solicit comments from academic investigators and clinicians associated with the use, research and/or development of pediatric neuroprostheses regarding approaches for enhancing the protection and promotion of...
Aug 20
The FDA has become aware of problems associated with the quality of mammograms performed at the Med Pro Imaging facility, formerly located at the following address: 7050 NW 4th Street, Suite #202, Plantation, Fla. 33317. Med Pro is under new management...
Aug 20
The Tootsie Tanner, a portable foot tanning device, is labeled with an improper exposure schedule and has an inadequate timer control, each of which could lead to an overdose of ultraviolet radiation. The labeled exposure schedule indicates the product...
Aug 20
The FDA is announcing a public Workshop to solicit information from academic investigators and clinicians associated with the use, research and/or development of pediatric neuroprostheses regarding approaches for enhancing the protection and promotion...
Aug 20
The FDA is is announcing a public meeting on the reauthorization of the medical device user fee program. The current legislative authority for the medical device user fee program expires in September 2012 and new legislation will be required for FDA...
Aug 19
The FDA is reopening until September 15, 2010, the comment period for the notice that published in the Federal Register of Thursday, June 17, 2010 (75 FR 34463).
Aug 16
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices Advisory...
Aug 13
The FDA is announcing a public meeting on the reauthorization of the medical device user fee program. The current legislative authority for the medical device user fee program expires in September 2012 and new legislation will be required for FDA to...
Aug 13
The Company identified that some devices in the affected batches have the potential for separation of the shaft (sheath) from the hub or for a break in the hub assembly. If either of these were to occur during use, a potentially life threatening...
Aug 11
Several peer-reviewed clinical studies report an increase in bloodstream infections following the introduction and use of positive displacement needleless connectors in healthcare facilities, as well as a reduction in infections after changing to another
Aug 09
The FDA is publishing a comprehensive list of all guidance documents currently in use at the agency. This list is being published under FDA's GGPs. It is intended to inform the public of the existence and availability of all of our current guidance...
Aug 09
Rarely have devices been developed, evaluated and approved specifically for treatment of children with congenital heart disease. The small, heterogeneous population, need for long-term follow-up, lack of market incentive, and misperceptions of...
Aug 09
IVC filter usage has increased rapidly during the past thirty years. In 1979, 2,000 IVC filters were used, while in 2007, almost 167,000 filters were implanted, and the market for IVC filters is only expected to increase, with an estimated 259,000 IVC...
Aug 09
FDA has become aware of suspected counterfeit C-A-T ® tourniquets. The suspected counterfeit tourniquets have subtle differences in stitching, printing of the logo and molding of plastic parts. They may be packaged and labeled for a distributor other than
Aug 09
The topic to be discussed is pediatric cardiovascular device development. The purpose of the public workshop is to solicit information from clinicians, academia, professional societies, other government agencies, and industry on various efficient and...
What's New: Devices & Radiology