Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff - FDA Decisions for Investigational Device Exemption (...November 10, 2011 3:31 am | by U.S. Food & Drug Administration | News | Comments
This guidance document has been developed to promote the initiation of clinical investigations to evaluate medical devices under FDA?s Investigational Device Exemptions (IDE) regulations, Title 21 Code of Federal Regulations (CFR) Part 812.
Draft Guidance for Industry and Food and Drug Administration Staff - Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including C...November 10, 2011 3:30 am | by U.S. Food & Drug Administration | News | Comments
This document is intended to provide guidance to FDA staff, clinicians, clinical innovators, and industry on the development and review of Investigational Device Exemption (IDE) applications for early feasibility studies of significant risk devices.
Potential for patient falls or unanticipated patient movement, which may result in serious injury or death.
The ACCORD Lipid trial found no significant difference in the risk of a major adverse cardiac event between group treated with fenofibrate plus simvastatin compared with simvastatin alone.
This webpage gives tips for safely disposing needles and other sharp devices that are used outside of health care settings. Patients and caregivers should keep these tips in mind when at home, at work, and while traveling.
NEW YORK, Nov. 8, 2011 /PRNewswire/ --Â A group of states and vendors focused on eliminating the barriers to sharing electronic health records (EHRs) today issued a set of technical specifications to standardize connections between healthcare providers, health information exchanges (HIEs)...
Industry's October 6, 2011 proposal allows applicants 15 days to draft pre-submission meeting minutes followed by 15 days for FDA to provide edits to the applicant?s draft minutes and 15 days for the applicant to indicate disagreement with how a...
Public Workshop - Bridging the IDEAL and TPLC Approaches for Evidence Development for Surgical Medical Devices and Procedures, December 2, 2011November 7, 2011 4:30 am | by U.S. Food & Drug Administration | News | Comments
The purpose of the public workshop is to provide a forum for discussion among FDA, governmental agencies, academia, physicians and various stakeholders to f urther refine and advance the IDEAL initiative (Idea Development Exploration, Assessment and...
Failure to adequately ventilate may lead to hypoxia or hypercarbia, which may result in serious neurological injury or death.
U.S. Senators, Clinicians and People with Type 1 Diabetes Urge FDA to Issue Clear and Reasonable Guidance on Artificial PancreasNovember 2, 2011 7:32 pm | News | Comments
Washington, D.C. â€“ U.S. Senators, clinical experts, and people with type 1 diabetes (T1D) today urged the Food and Drug Administration (FDA) to issue clear and reasonable guidance on the artificial pancreas (AP) that avoids unnecessary delays in development and delivery of a medical technology...
Meeting Materials for National Mammography Quality Assurance Advisory Committee meeting on November 4, 2011November 2, 2011 4:30 am | by U.S. Food & Drug Administration | News | Comments
The National Mammography Quality Assurance Advisory Committee advises on developing appropriate quality standards and regulations for the use of mammography facilities.
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.