Guidance for Industry and Food and Drug Administration Staff - User Fees for 513(g) Requests for InformationApril 6, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments
Title II of the Food and Drug Administration Amendments Act of 2007 (FDAAA), also termed the Medical Device User Fee Amendments of 2007, P.L. 110-85, extends FDA?s authority to collect medical device user fees by establishing a fee for ?a request for...
Guidance for Industry and Food and Drug Administration Staff - FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmet...April 6, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments
The purpose of this guidance is to establish procedures for submitting, reviewing and responding to requests for information regarding the class in which a device has been classified or the requirements applicable to a device under the Federal Food, Drug,
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (June 21, 2012)April 4, 2012 9:31 pm | by U.S. Food & Drug Administration | News | Comments
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.
Thoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS): Class 1 Recall- Outflow Graft May Kink or DeformApril 4, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments
May result in reduction of blood flow from the pump, pump/graft thrombosis, or perforation of the outflow graft.
Class I Medical Device Recall: Thoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS)April 4, 2012 9:31 am | by U.S. Food & Drug Administration | News | Comments
Detachment of the bend relief from its intended position around the proximal outflow graft may allow the graft to kink or deform, resulting in reduction of blood flow from the HeartMate II LVAS pump, pump/graft thrombosis, or perforation of the outflow...
The counterfeit product may have resulted in patients not receiving needed therapy.
Stryker’s Wingspan stent could be yanked from the market if the FDA heeds March 23 recommendations of its Neurological Devices Panel.
CDRH would move into a “death spiral” if Medical Device User Fee Act (MDUFA) legislation is not reauthorized this summer, director Jeffrey Shuren warned at a Senate Health, Education, Labor & Pensions (HELP) committee hearing Thursday.
Celexa (citalopram hydrobromide) - Drug Safety Communication: Revised Recommendations, Potential Risk of Abnormal Heart RhythmsMarch 28, 2012 5:31 am | by U.S. Food & Drug Administration | News | Comments
Revised drug label clarifying dosing and warning recommendations.
FDA has developed this guidance as the special control to support classification of full-field digital...
FDA has published a first-of-a-kind guidance for medical device manufacturers, describing how the benefits...
Starting June 5, devicemakers audited according to internationally harmonized regulatory standards could be spared some annual FDA inspections, under a pilot program described in a final guidance.
Last week’s U.S. Supreme Court decision on the patent eligibility of a diagnostic could have ramifications for in vitro diagnostic (IVD) devicemakers, limiting investment in novel tests because of uncertainty about what is and is not patentable, a U.S. patent attorney tells D&DL.
Risk of embolization/infarction to organs and potential organ complications.
This presentation explains FDA's new voluntary audit report submission pilot program, which is based on ISO 13485, an international standard utilized in the medical-device sector in many places around the world.
WASHINGTON, D.C. â€“ Today, with tens of thousands of patients suffering grave health effects as a result of defective medical devices, Congressman Edward J. Markey (D-Mass.) released a comprehensive new report titled â€œDefective Devices, Destroyed Lives: Loophole Leaves Patients Unprotected...
WASHINGTON, D.C. â€“ Today, Congressman Edward J. Markey (D-Mass.), a senior member of the Energy and Commerce Committee, which has jurisdiction over the Food and Drug Administration (FDA), will be joined by a patient, surgeon and health advocate at the release of a new report...
Reports of eye infections in patients who were given Brilliant Blue G during eye surgeries.
Nearly half of devicemakers (44 percent) in a recent survey said they would pass the costs of the new medical device excise tax on to their customers.
The FDA expects to collect $595 million in device user fees by fiscal 2017, according to the FDA’s outline for the reauthorization of the Medical Device User Fee Act (MDUFA).
Guidance for Industry, Third Parties and Food and Drug Administration Staff - Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot ProgramMarch 16, 2012 5:31 am | by U.S. Food & Drug Administration | News | Comments
This guidance provides information on the implementation of section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Public Law 110-85, which amended section 704(g)(7) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)...
Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detect...March 16, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments
This document was developed to support the reclassification of nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) in respiratory specimens from class III into class II. These devices are...
Skin Creams, Soaps and Lotions Marketed as Skin Lighteners and Anti-aging Treatments: May Contain the Toxic Metal, MercuryMarch 15, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments
Products with this toxic metal have been found in at least seven states, are manufactured abroad and often sold in shops in Latino, Asian, African or Middle Eastern neighborhoods and online.
The purpose of the meeting is to provide an opportunity for stakeholders to present their views on the draft recommendations for the reauthorization of the medical device user fee program. We welcome this opportunity to hear from stakeholders as we...
FDA reported that they have concluded negotiations with Industry. On February 17, 2012 they reached agreement with all four industry associations Industry on the final details of the fee structure and minor changes to the draft Commitment Letter and...