FDA Update The Safety of Syringes Imported into the US Called into Question As: The FDA Sends Two Warning Letters after Inspecting Chinese Syringe Manufacturers The FDA named companies Jiangsu Shenli and Jiangsu Caina as targets of its investigation into the safety of plastic syringes made in China in March. The agency had not completed
Common Mistakes Medical Device Manufacturers Make Today’s economic healthcare environment has created overwhelming reimbursement challenges. The situation is frequently complex and the stakes are high. Companies need not wait for FDA approval before addressing reimbursement issues which they should begin early in the medical device’s development. Putting reimbursement on the back burner until after launch
Updated FDA Guidance regarding Medical Device Accessories and Classification Pathways!! The FDA has just released an updated final guidance entitled, “Medical Device Accessories – Describing Accessories and Classification Pathways”. This guidance was originally issued out to industry and FDA staff one year ago in December of 2016. This update focuses on explaining new mechanisms to
FDA Proposed Rule October 17, 2016 The Food and Drug Administration (FDA) is proposing to implement provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require electronic submission of the device label and package insert of certain home-use devices when these devices are listed with FDA. The electronic submission requirements of
St. Jude Medical Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are both implanted under the skin in the upper chest area with connecting insulated wires called “leads” that go into the heart devices that provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms. St.
Portable blood glucose meters that measure blood glucose values are used by millions of 28 people with diabetes every day as an aid in diabetes self-management. In recent years, concerns have been raised related to infection control issues involving blood glucose meters and lancing devices. This guidance document describes studies and criteria that FDA recommends
A graduate of Duke University School of Medicine, Dr. Califf completed his residency in internal medicine at University of California and a fellowship in Cardiology at Duke University. Prior to his appointment as Commissioner, Dr. Califf has served as FDA’s Deputy Commissioner for Medical products and Tobacco from February 2015 and has provided executive leadership
Insight Report Vol. 13 No.1 Prepared by: Aditya Sukthankar Background: A wide-ranging surveillance operation by the Food and Drug Administration against a group of its own scientists used an enemies list of sorts as it secretly captured thousands of e-mails that the disgruntled scientists sent privately to members of Congress, lawyers, labor officials, journalists and
Background: The Department of Health and Human Services (HHS), of which the Food and Drug Administration (FDA) is a part, recently published “Contingency Staffing Plan for Operations in the Absence of Enacted Annual Appropriations.” Essentially, this Plan is the SOP for how HHS and FDA will operate under the current partial government shutdown. Under this
FDA compliance has been much more difficult to deal with By Alan Schwartz What is going on with the FDA? Is the FDA on a war-path judging by the ever increasing number of facility inspections? Or is it like any bureaucracy, they have taken on too much work without clearly assessing the consequences for companies,
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