The FDA’s foreign posts are working more with regulators and industry to improve the safety of products made overseas.
By Jeff Shuren, M.D., J.D., Director of FDA's Center for Devices and Radiological Health.
Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval ApplicationsJune 24, 2010 6:32 am | by U.S. Food & Drug Administration | News | Comments
This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.
Federal Register: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of MeetingJune 24, 2010 6:31 am | by U.S. Food & Drug Administration | News | Comments
On August 26, 2010, the committee will discuss, make recommendations, and vote on premarket approval application for MelaFind, sponsored by MELA Sciences, Inc. MelaFind is a non-invasive computer vision system intended to assist in the evaluation of...
Drug failed to demonstrate clinical benefit to patients enrolled in trials.
Product marketed as a dietary supplement for sexual enhancement contains the drug ingredient hydroxythiohomosildenafil, a chemical that may interact with prescription nitrates, and cause dangerously low blood pressure.
Recurring complaints of leaking packages of natural collagen vascular grafts have resulted in a warning letter to Artegraft that cites a number of good manufacturing (GMP) problems related to the leaks.
Although Optovue is taking corrective action to bring a normative database used with its RTVue optical coherence tomography into compliance, it received a warning letter that notes the effectiveness of the corrections can’t be fully reviewed and evaluated because they are ongoing.
Potentially harmful product represented as â€œGeneric Tamifluâ€- tests revealed product does not contain oseltamivir, but cloxacillin, an antibiotic.
UPDATED 06/17/2010. Recall expanded to include product lots of Benadryl Allergy Ultratab Tablets and Extra Strength Tylenol Rapid Release Gels.
The purpose of the public meeting is to create a forum for interested stakeholders to discuss the agency's oversight of laboratory developed tests (LDTs). FDA is seeking input and requesting comments on this topic.
Federal Register: Converged Communications and Health Care Devices Impact on Regulation; Public Meeting; Request for CommentsJune 17, 2010 5:30 am | by U.S. Food & Drug Administration | News | Comments
The purpose of this meeting is to identify the challenges and risks posed by the proliferation of new sophisticated medical implants and other devices that utilize radio communications to effectuate their function, as well as challenges and risks posed by
Since the implementation of the 1976 Medical Device Amendments, the FDA has generally exercised enforcement discretion and not enforced applicable regulations with respect to LDTs, a class of in vitro diagnostics (IVDs) that are manufactured, including...
Public Meeting: Converged Communications and Health Care Devices Impact on Regulation, June 26-27, 2010June 15, 2010 5:35 am | by U.S. Food & Drug Administration | News | Comments
The objective of this meeting is to gather information and to better understand issues and perspectives from various stakeholders so the agencies can identify potential areas where each agency?s jurisdiction can be identified and clarified for affected...
A meeting regarding the Medical Device User Fee and Modernization Act.
Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; The Mammography Quality Standards Act Requi...June 15, 2010 5:35 am | by U.S. Food & Drug Administration | News | Comments
The Mammography Quality Standards Act requires the establishment of a Federal certification and inspection program for mammography facilities; regulations and standards for accreditation and certification bodies for mammography facilities; and standards..
Labeling, Approval Order, and Summary of Safety and Effectiveness for Karl Storz Photodynamic Diagnostic D-Light C (PDD) System (P050027).
Summary Information for: Elecsys & #xae; PreciControl Anti-HCV for use on the MODULAR ANALYTICS E170 Analyzer Cobas e 601 Immunoassay AnalyzerJune 14, 2010 7:35 am | by U.S. Food & Drug Administration | News | Comments
Labeling, Approval Order, and Summary of Safety and Effectiveness for Elecsys® PreciControl Anti-HCV for use on the MODULAR ANALYTICS E170 Analyzer Cobas e 601 Immunoassay Analyzer (P090009).
FDA evaluating data in which type 2 diabetes patients taking Benicar had a higher rate of death from cardiovascular cause compared to placebo. FDA has not concluded that Benicar increases the risk of death.
Federal Register: Dental Devices: Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam, Mercury, and Amalga...June 11, 2010 6:35 am | by U.S. Food & Drug Administration | News | Comments
The final rule was published with an inadvertent error in the codified section. This document corrects that error. This action is being taken to ensure the accuracy of the agency's regulations.
Injectable products may contain particulate matter.
Class I Recall and Safety Investigation of Counterfeit Polypropylene Surgical Mesh: Updated June 10, 2010June 10, 2010 6:35 am | by U.S. Food & Drug Administration | News | Comments
This is an update of FDA's Initial Communication on counterfeit polypropylene surgical mesh, which was issued on March 11, 2010. It contains additional information about the recall of this product and updates FDA's recommendations and activities.
AED may falsely detect an error condition during charging for a shock, then cancel charge and not provide therapy, when used with an affected battery pack.
[UPDATED 06/08/2010] Recall classified as Class I. Various sizes of counterfeit flat sheets of polypropylene surgical mesh marketed in the U.S. labeled with the C. R. Bard/Davol brand name.
Public Meeting - Array-Based Cytogenetic Tests: Questions on Performance Evaluation, Result Reporting and Interpretation, June 30, 2010June 8, 2010 5:36 am | by U.S. Food & Drug Administration | News | Comments
The purpose of this public meeting is to seek input on challenges related to performance evaluation, determination of clinical significance, result reporting, and interpretation for array-based cytogenetic tests.