News

FDA CDRH Latest News
	Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications.
	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...
	Guidance for Industry and FDA Staff - Impact-Resistant Lenses: Questions and Answers
	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...
	Federal Register: Guidance for Industry and Food and Drug Administration Staff; Impact-Resistant Lenses: Questions and Answers; Availability.
	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...
	Office of Device Evaluation Annual Performance Report Fiscal Year 2009
	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.
	Federal Register: Medical Device User Fee Act; Public Meeting; Request for Comments; Amendment of Notice
	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...
	Federal Register: Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations; Correction.
	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...
	FDA Safety Notification: Mammography Problems at Medisound, Inc. in Kissimmee, Florida
	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...
	CDRH Preliminary Internal Evaluations on the 510(k) Program and the Use of Science in Regulatory Decision Making (Webinar Information Updated)
	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..
	Class I Medical Device Recall: Multi-Med, Inc., 22 Gauge x 1 inch Straight and Right Angle Huber Needles and Navilyst Medical Inc., Vaxcel Implantable Vascular Access Systems Containing Huber Needles (Two Class I Recalls)
	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...
	Safety Investigation of Non-Coring (Huber) Needles: Updated August 26, 2010
	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...
	Use of Fingerstick Devices on More Than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication
	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...
	Federal Register: Effective Date of Requirement for Premarket Approval for Four Class III Preamendments Devices
	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.
	Federal Register: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop
	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
	Guidance for Industry and Food and Drug Administration Staff - Contact Lens Care Products Labeling
	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...
	Guidance for Industry and Food and Drug Administration Staff - Guidance for the Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH)
	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...
	Class I Medical Device Recall: Ikaria Holdings, INOMAX DS Drug Delivery System
	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...
	PMA Final Decisions for July 2010
	These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for July 2010.
	Public Workshop - Medical Devices and Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations, September 23, 2010
	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...
	Federal Register: Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations
	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...
	Federal Register: ASK (Assess Specific Kinds of CHILDREN Challenges for Neurologic Devices) Study Children Workshop; Public Workshop; Request for Comments
	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...
	FDA Safety Notification: Mammography Problems at Med Pro Imaging in Plantation, Florida
	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...
	FDA Safety Notification: Ultraviolet Radiation Over-Exposure from Tootsie Tanner, a Portable Foot Tanning Device
	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...
	Public Workshop - ASK CHILDREN (Assess Specific Kinds of CHILDREN Challenges for Neurologic Devices) STUDY Workshop, September 13, 2010
	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...
	Public Workshop - Medical Device User Fee Program Public Meeting, September 14, 2010
	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...
	Federal Register: Oversight of Laboratory Developed Tests; Public Meeting; Reopening of the Comment Period
	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).
	Federal Register: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Meeting on November 18, 2010
	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...
	Federal Register: Medical Device User Fee Act; Public Meeting; Request for Comments; Meeting on September 14, 2010
	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...
	Class I Medical Device Recall: St. Jude Medical 6 French Engage? Introducer Devices
	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...
	Positive Displacement Needleless Connectors and Bloodstream Infections: Initial Communication
	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
	Federal Register: Comprehensive List of Guidance Documents at the Food and Drug Administration; Notice
	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...
	Public Workshop - Optimizing Clinical Trial Design for the Development of Pediatric Cardiovascular Devices, September 30th, 2010
	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...
	Removing Retrievable Inferior Vena Cava Filters: Initial Communication
	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...
	Safety Investigation of Suspected Counterfeit Combat Application Tourniquets (C-A-T®): Initial Communication
	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
	Federal Register: Workshop on Optimizing Clinical Trial Design for the Development of Pediatric Cardiovascular Devices
	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...