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News and Info

11 Oct

FDA announce guidance for Blood Glucose Monitoring Test Systems (BGMS) for Prescription Point-of-Care Use; Guidance for Industry and Food and Drug Administration Staff.

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

Oct

Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use; Guidance for Industry and Food and Drug Administration Staff

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

01 Oct

It’s that time of year!! RENEW YOUR FOOD FACILITY REGISTRATION WITH FDA.

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

19 Sep

The Consumer Hand Sanitizers And Wipes Are Under New FDA Scrutiny

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

08 Sep

The New Normal For Consumer Antiseptic Wash Manufacturers!!

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

07 Sep

The deadline for the UDI compliance is fast approaching and at this juncture the FDA rule to extend the deadlines for certain class II device is a big relief for some labelers!!!

FDA has extended the compliance date for UDI label and GUDID submission requirements to September 24, 2018, for certain class II devices!! FDA has also clarified that the UDI and GUDID compliance date for certain device constituents of certain combination products will be September 2018. The UDI and GUDID extension applies to the below devices

11 Jul

Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices!!

Electromagnetic Compatibility (EMC) is the ability of a device to function safely and effectively in its intended electromagnetic environment, including immunity to electromagnetic disturbance (interference), without introducing excessive electromagnetic disturbances (emissions) that might interfere with other devices. EMC information in a submission is reviewed based on the risk associated with EMC malfunction or degradation of

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