Public Workshop - Using Scientific Research Data to Support Pediatric Medical Device Claims, December 5, 2011November 1, 2011 12:31 pm | by U.S. Food & Drug Administration | News | Comments
The purpose of the public workshop is to receive public comment on the use of scientific research data, including published scientific literature, to extrapolate effectiveness claims from adults to children and between pediatric subpopulations in order...
Provides an in-depth look at challenges industry and the FDA face in implementing well-integrated, best-quality manufacturing practices. The report also presents recommendations on ways industry and the FDA can work to remove the perceived barriers to...
An FDA ban on over-the-counter asthma inhalers containing chlorofluorocarbons would be voided by a bill introduced by Sen. Pat Roberts (R-Kan.).
The FDA stands to receive 300 to 500 percent more 510(k) submissions if the agency implements a draft guidance on when to file a 510(k) for a change to an existing device, AdvaMed says.
Leading Innovator Alpha-Stim Gains Support of Medical Professionals and Patients in Opposing New FDA RuleOctober 25, 2011 10:37 am | News | Comments
MINERAL WELLS, Texas--(BUSINESS WIRE)--Alpha-Stim, cranial electrotherapy stimulation (CES) devices providing treatment for anxiety, depression, insomnia and pain, announces its user-supported campaign to change an FDA rule regarding Pre-Market Approval (PMA),
The FDA has learned that some manufacturers are continuing to market baby products that claim to prevent or reduce the risks of Sudden Infant Death Syndrome (SIDS) without FDA clearance or approval. Under section 201(h) of the Federal Food Drug &..
Some baby products are being marketed over-the-counter with claims to cure, treat, or prevent a disease or condition. Because of these claims, these baby products are medical devices, subject to FDA regulation.
Presence of a silicone oil residue on lenses from certain lots of my cause range of symptoms such as hazy, blurry vision, discomfort to eye injuries requiring medical treatment.
Industry resistance to an FDA move to fund training and hiring with user fee revenues has the agency concerned about missing a Jan. 15 deadline to give Congress proposals for the third reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA).
Device innovation is suffering because FDA conflict of interest rules keep experienced and insightful practitioners from serving on advisory panels, industry and lawmakers say.
Reason for Recall: The unintended presence of a silicone oil residue on lenses from certain lots of Avaira Toric contact lenses. Symptoms may range from hazy, blurry vision, discomfort to eye injuries requiring medical treatment.
AdvaMed, MDMA, and MITA jointly offered preliminary feedback on the counter-proposal presented by the Agency on August 24 th. Industry stated that they appreciated the Agency?s effort to put forward proposals that addressed the issued important to...
The FDA is advising health care professionals and health care facility executives and staff on factors that increase the risk of surgical fires, particularly the delivery of supplemental oxygen to patients...
You may want to look like your favorite movie star or singer or have the perfect look for Halloween, but choosing to change the look of your eyes with contact lenses could cause a lot of damage to your eyesight.
Patients should be evaluated for signs and symptoms of underlying cardiopulmonary disease prior to starting Sprycel, as well as during treatment.
Device companies are maintaining a united front against an Institute of Medicine (IOM) recommendation that the FDA discard the 510(k). But some of what IOM has to say about other aspects of device oversight warrants consideration, commenters state.
The FDA has plans to revamp its clock and calendar for calculating how long device reviews take and would like to allocate user fee funds to internal training.
The FDA and CMS have established a pilot program for concurrent review of certain FDA premarket review submissions for medical devices and CMS national coverage determinations.
Product marketed as testosterone booster contains superdrol, a synthetic steroid. Use of synthetic anabolic steroids may cause serious long-term adverse health consequences.
The Agency provided a response and counter-proposal to Industry's July 26, 2011 proposal that the Agency viewed as being responsive to Industry?s requests and objectives. The Agency indicated its goal of achieving several objectives that are held in...
The purpose of the Network of Experts is to provide staff at the Center for Devices and Radiological Health (CDRH, Center) with rapid access to scientific, engineering, and medical expertise when it is needed to supplement existing knowledge and expertise
An SOP on the selection and enrolment of organizations for the Center for Devices and Radiological Health (CDRH) Network of Experts.
Denture adhesives are pastes, powders or adhesive pads that may be placed in/on dentures to help them stay in place. Sometimes denture adhesives contain zinc to enhance adhesion...
Reason for Recall: These custom dialysis trays/kits contain alcohol swabs and prep pads that were recalled by H & P Industries. The alcohol swabs and prep pads may not be sterile. Patients receiving hemodialysis who use the swabs and pads may be at...
Taking a device to Europe to gain quicker market access is a short-term fix, not the solution to maintaining innovation.