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.
Historically, FDA has not recommended different types of information in 510(k)s for BGMSs used by healthcare professionals as compared to SMBGs intended for home use by lay-users. In order to distinguish between FDA recommendations for prescription-use blood glucose meters, which are intended for use in point-of-care professional healthcare settings, and SMBG devices intended for home
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
As a part of The Public Health Security and Bio-terrorism Preparedness and Response Act of 2002 (the Bio-terrorism Act) FDA established regulation that require Food facility to be registered with FDA and give advance notice to FDA on shipments of imported food. The FDA Food Safety Modernization Act (FSMA), enacted on January 4, 2011, amended
Background The FDA Total Product Life Cycle (TPLC) database combines data from various CDRH databases (data sources) to present an integrated record of premarket and postmarketed activity for medical devices. A critical bug in the FDA CDRH TPLC database prevented the names of some 510K companies from being displayed appropriately. Apparently the FDA IT team
On September 21, 2016 FDA issued a Draft guidance to assist Drug Sponsor and Device Manufacturer to encourage coordination in development of Antimicrobial Drugs and Antimicrobial Susceptibility Test (AST) devices so that AST device can be cleared at the time of NDA or shortly after that. AST is an important component in development of new
As of June 29, 2016, FDA has started collection of additional safety and effectiveness data for certain active ingredients present in over-the-counter (OTC) consumer antiseptic rubs. The consumer antiseptic rubs include hand sanitizers and antiseptic wipes that are intended to be left on and not rinsed off with water. These products are used by consumers
The FDA Food Safety Modernization Act (FSMA) which aims to ensure the safe supply of food into USA was enacted into law in 2011.FDA has announce a total of $21.8 million funding to support 42 states in successful implementation of product Safety rule under FSMA. Based on the number of farms growing the covered products
On September 2, 2016, FDA issued a final rule for over-the-counter (OTC) consumer antiseptic washes that banned certain active ingredients previously used in these products. The consumer antiseptic wash products include hand soaps, hand and body washes that are intended for use with water and are rinsed off after use. The new rule prohibits 19
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