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Category Archives: FDA Updates

Final Guidance on Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions
17 Feb

Final Guidance on Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions

Final Guidance on Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions. This guidance document explains the principal factors that FDA considers when assessing benefits and risks of original IDE applications, IDE amendments and IDE supplements for human clinical investigations of certain medical devices to determine safety and effectiveness. The approach

18 Jan

FDA provides updated information on 3D Printing of Medical Devices.

FDA provides updated information on 3D Printing of Medical Devices. 3D printing is a process that creates a three-dimensional object by building successive layers of raw material. Each new layer is attached to the previous one until the object is complete. Objects are produced from a digital 3D file, such as a computer-aided design (CAD)

Jan

FDA ensures safety of Cosmetic products

FDA ensures safety of Cosmetic Products Using Adverse Event Reports to Monitor Cosmetic Safety!! Cosmetics are a broad category of products that, by law, are intended to, among other things, cleanse or alter appearance. Per Linda Katz, M.D., MPH, director of the FDA’s Office of Cosmetics and Colors “Every person uses some cosmetic product on

Electronic Submission of Labeling for Certain Home-Use Medical Devices, submit your comments
17 Oct

Electronic Submission of Labeling for Certain Home-Use Medical Devices!!

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

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

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