Regulatory
UDI Rule Could See Light of Day Soon, OMB Sign-Off Expected, FDAer Says
May 25, 2012 2:30 pm | by U.S. Food & Drug Administration | News | CommentsThe Office of Management and Budget (OMB) could release the FDA’s proposed rule on a unique device identification (UDI) system “any day now,” an agency official says, ending a nearly year-long delay in finalizing the much-anticipated safety mechanism.
Final Senate MDUFA Package Omits Device Tax Repeal
May 25, 2012 2:30 pm | by U.S. Food & Drug Administration | News | CommentsThe Senate voted 96-1 on Thursday to approve an omnibus FDA user fee bill, but earlier in the week rejected including an industry-backed amendment to repeal the upcoming medical device excise tax.
Baxa Corporation Abacus Total Parenteral Nutrition (TPN) Calculation Software: Class I Recall - Potential Dosing Errors
May 25, 2012 11:30 am | by U.S. Food & Drug Administration | News | CommentsProblems associated with mix-ups related to salt-based or ion-based ordering of electrolytes.
FDA Safety Communication: Dialysate Concentrates and Alkali Dosing Errors with Hemodialysis
May 25, 2012 6:31 am | by U.S. Food & Drug Administration | News | CommentsThe FDA received a complaint describing alkali dosing errors that occurred during hemodialysis using dialysate concentrates containing acetic acid and acetate. When metabolized, these potential sources of alkali can contribute to elevated bicarbonate...
Dialysate Concentrates Used in Hemodialysis: Safety Communication - Alkali Dosing Errors
May 25, 2012 6:30 am | by U.S. Food & Drug Administration | News | CommentsRisk of elevated bicarbonate levels in patients undergoing hemodialysis, which can contribute to metabolic alkalosis, a significant risk factor associated with cardiopulmonary arrest, low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia.
Franck’s Compounding Pharmacy Sterile Preparations: Reports of Fungal Endophthalmitis, Expanded Recall
May 24, 2012 6:31 pm | by U.S. Food & Drug Administration | News | CommentsRecall of all products sold by Franck's since November 2011 due to the possibility of lack of sterility.
Hospira Carpuject Pre-filled Cartridges - Drug Alert: Products May Contain More Than the Intended Fill Volume
May 23, 2012 5:31 am | by U.S. Food & Drug Administration | News | CommentsHealthcare professionals should visually inspect and confirm that the cartridge contains the labeled fill volume before dispensing and again before administering to patients.
West Coast Nutritionals Dietary Supplement Products: Recall - Undeclared Drug Ingredient
May 21, 2012 7:31 am | by U.S. Food & Drug Administration | News | CommentsProducts marketed as dietary supplements contains drug ingredient Tadalafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.
Public Meeting - Clinical Study Design and Performance of Hospital Glucose Sensors, June 25, 2012
May 21, 2012 5:30 am | by U.S. Food & Drug Administration | News | CommentsFDA is seeking input from the clinical community, academia, Government, industry, clinical laboratories, and other stakeholders regarding clinical validation studies and performance criteria for innovative hospital glucose sensors...
Senate Vote on Revised User Fee Package Planned for This Week
May 18, 2012 2:30 pm | by U.S. Food & Drug Administration | News | CommentsThe Senate plans to debate and vote on an omnibus FDA user fee bill this week, after lawmakers substituted a new bill for the prior reauthorization package and began discussing it on Thursday.
FDA Increasing Role in Quality Promotion for Devicemakers, CDRH Official Says
May 18, 2012 2:30 pm | by U.S. Food & Drug Administration | News | CommentsCDRH officials plan a series of public forums in 2012 to gather data to develop an implementation plan for the center’s Case for Quality Initiative – which aims to create an ongoing culture of quality at medical device manufacturers.
Requesting Speakers from CDRH
May 18, 2012 11:30 am | by U.S. Food & Drug Administration | News | CommentsThe following explains the process for requesting speakers from the Center for Devices and Radiological Health (CDRH) to participate in meetings, conferences, and workshops which are being sponsored by outside organizations...
Zithromax (azithromycin): FDA Statement on risk of cardiovascular death
May 17, 2012 12:31 pm | by U.S. Food & Drug Administration | News | CommentsA retrospective cohort study reports small increase in risk of cardiovascular deaths and risk of all cause deaths associated with 5 day course of antibiotic drug
Upcoming Webinar on Hearing Aids: The Basic Information You Need to Know (5/23/12)
May 15, 2012 9:30 am | by U.S. Food & Drug Administration | News | CommentsLearn more Wednesday, May 23, 2012 at 2:00 p.m. ET, when FDA's Center for Devices and Radiological Health (CDRH) will host a 30-minute Webinar to discuss basic information on Hearing Aids.
Impending IEC 60601 Leaves Medical Companies Struggling with Rules on Sustainable Design
May 15, 2012 5:48 am | News | CommentsThe issue of ‘sustainability’ is becoming increasingly important for the medical industry since the implementation of the ‘International standard for environmentally conscious design of electronic medical equipment’ (IEC 60601-1-9) introduced in 2007.
Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject: Recall - May Contain More Than the Intended Fill Volume
May 14, 2012 9:30 am | by U.S. Food & Drug Administration | News | CommentsAn overdose of Hydromorphone may result in life-threatening consequences, including respiratory depression (slowed breathing or suspension of breathing), low blood pressure, and reduced heart rate including circulatory collapse.
Industry: IRS Needs to Better Define & #8216;Taxable Use & #8217; in Excise Tax Rule
May 11, 2012 2:30 pm | by U.S. Food & Drug Administration | News | CommentsInternal Revenue Service guidelines on the 2.3 percent medical device tax should make clear that manufacturers won’t have to pay taxes on products from which they derived no direct benefit, such as demonstration products and replacement parts provided free of charge, AdvaMed said in...
MDUFA Moves to House Floor, Decision Summaries for Some 510(k)s Likely
May 11, 2012 2:30 pm | by U.S. Food & Drug Administration | News | CommentsAn omnibus FDA user fee bill passed last week by the House Energy and Commerce Committee includes a variety of measures aimed at reforming the medical device regulatory process, including a provision requiring the FDA to withdraw its controversial guidance on when manufacturers should...
FDA Safety Communication: Chronic Cerebrospinal Venous Insufficiency Treatment in Multiple Sclerosis Patients
May 10, 2012 6:30 am | by U.S. Food & Drug Administration | News | CommentsThe FDA is alerting people with MS to the risks of serious injuries and death associated with procedures to treat chronic cerebrospinal venous insufficiency (CCSVI). Furthermore, the benefits of these experimental procedures have not been proven...
Pediatric X-ray Imaging
May 10, 2012 1:30 am | by U.S. Food & Drug Administration | News | CommentsMedical imaging has led to improvements in the diagnosis and treatment of numerous medical conditions in children and adults. There are many types - or modalities - of medical imaging procedures that are used on children, each of which uses different...
Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging
May 10, 2012 1:30 am | by U.S. Food & Drug Administration | News | CommentsLike all medical procedures, computed tomography (CT), fluoroscopy, and nuclear medicine imaging...
Public Workshop - Device Improvements for Pediatric X-ray Imaging, July 16, 2012
May 9, 2012 5:31 am | by U.S. Food & Drug Administration | News | CommentsThe main purpose of the workshop is to discuss the draft guidance Pediatric Information for X-ray Imaging Device Premarket Notifications. This guidance will apply to x-ray computed tomography, general and dental radiography, and diagnostic and...
Draft Guidance for Industry and Food and Drug Administration Staff - Pediatric Information for X-ray Imaging Device Premarket Notifications
May 9, 2012 5:30 am | by U.S. Food & Drug Administration | News | CommentsThis guidance document outlines the FDA's current thinking on information that should be provided in premarket notifications for x-ray imaging devices with indications for use in pediatric populations. The Agency intends for this guidance to minimize...
Innovation Pathway Advances May Be Expanded Throughout Agency
May 4, 2012 2:31 pm | by U.S. Food & Drug Administration | News | CommentsCINCINNATI — Regulatory advances made during the Innovation Pathway 2.0 project to develop new treatments for end-stage renal disease may quickly be rolled throughout CDRH, center Director Jeffrey Shuren said Wednesday at the FDA/Xavier University MedCon Conference here.
Devicemakers Could Gain from Obama & #8217;s Call for More Regulatory Harmonization
May 4, 2012 2:31 pm | by U.S. Food & Drug Administration | News | CommentsThe FDA may need to better match its regulations with those of key trading partners, a move that could benefit the increasingly global device industry, thanks to a new executive order (EO), 13609, signed by President Barack Obama Tuesday.
