Tag: FDA

Last Updated on December 19, 2023
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Posted in BLOG, FDA Updates
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Leave a Comment on New premarket submission route: FDA’s eSTAR Program from pilot to production by Oct 1, 2023

By - SebastianFeye

New premarket submission route: FDA’s eSTAR Program from pilot to production by Oct 1, 2023

In September of 2018, the FDA took their first step to improve and modernize the process of a 510(k) electronic submission. This commitment was established as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) that was enacted on July 9, 2012, amending the FD&C Act by adding section 745A. As part of this Act, a program

Tagged : device, eCopy, electronic, FDA, Guidance, Health Canada, medical, modernization, PDF, Pilot, premarket, process, Program, submission

Last Updated on June 15, 2023
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Posted in BLOG, FDA Updates
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Leave a Comment on New Updated 2023 FDA Final Guidance Significantly Changing Premarket Submissions Requirements for Medical Device Software

By - SebastianFeye

New Updated 2023 FDA Final Guidance Significantly Changing Premarket Submissions Requirements for Medical Device Software

Medical Device software continues to evolve and change as do FDA regulations. When it comes to the content of the software documentation requirements for a pre-market submission (510k), the FDA’s last issued guidance back in 2005. However, on June 14 2023, FDA released a new and revised final guidance document which substantially alters software requirements for 510k submissions by changing

Tagged : 510(k), 510k, FDA, Guidance, Medical Devices, SAMD, Software, Specifications, SRS

Last Updated on May 20, 2021
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Posted in BLOG, FDA Updates
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Leave a Comment on Artificial Intelligence and Machine Learning Workflow Driving Innovative Medical Device Development

By - SebastianFeye

Artificial Intelligence and Machine Learning Workflow Driving Innovative Medical Device Development

In 2011, Marc Andreessen, a venture capitalist, stated “Software is Eating the World”. Ten years later, software development has accelerated and expanded industries that could not have been imagined a decade ago. Automated medical devices are central to this phenomenon and complex software programs with increasingly advanced algorithms are designed to operate with hardware in order to fulfill its intended

Tagged : 510(k), Artificial Intelligence, FDA, Improvement, Lifecycle, Machine Learning, Medical Devices, Product, Regulatory, SAMD, Software, Specifications, Total, TPLC, Transparency

Last Updated on January 19, 2021
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Posted in BLOG, How-To
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Leave a Comment on An Overview of FDA Inspections across Drugs, Biologics and Medical Devices

By - SebastianFeye

An Overview of FDA Inspections across Drugs, Biologics and Medical Devices

The Food and Drug Administration (FDA) primary responsibility is the enforcement of the Federal Food, Drug and Cosmetic (FD&C) Act that tasked the agency with protecting and promoting public health and authorized the “legality of an FDA inspection, conducted at a reasonable time, within reasonable limits, and in a reasonable manner, depends not on consent but on the validity of

Tagged : CBER, FDA, Inspections, Pre-approval Inspections, subsystems

Last Updated on August 31, 2020
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Posted in BLOG, FDA Updates, News
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Leave a Comment on New Medical Device Pathway: Safety and Performance Based Pathway

By - SebastianFeye

New Medical Device Pathway: Safety and Performance Based Pathway

In late 2019, the FDA introduced a new Safety and Performance Based Pathway which can potentially speed up the preparation and review process for certain submitters of pre-market notification medical device submissions. This optional pathway was created by the FDA to assist with well understood device types, in which a submitter references device specific guidance’s detailing the appropriate testing standards,

Tagged : 510(k), catheters, coils, contact lenses, cutaneous, device, eCopy, electrodes, FDA, foley, Guidance, industry, magnetic, medical, orthopedic, pathway, performance, plating, regulators, safety, screws, spinal, submission, washers

Last Updated on May 21, 2021
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Posted in BLOG, FDA Updates
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Leave a Comment on 2020 Over-the-Counter (OTC) Drug Monographs Reform Summary

By - SebastianFeye

2020 Over-the-Counter (OTC) Drug Monographs Reform Summary

Updated: March 26, 2021 – FDA has stated that MDF facility fees will be $20,322, and CMO facility fees will be $13,548. Over-the-Counter (OTC) drug monographs represent current regulatory standards for the marketing of non-prescription drug products not covered by new drug applications. These standards provide the marketing conditions for some OTC drug products including the active ingredients, labeling, and

Tagged : Adminstration, CARES Act, drug, drugs, FDA, Food, Food and Drug Administration, GRASE, Medicine, monograph, OMOR, OTC Monograph Order Request, Over-the-counter, Program, reform, User fees

Last Updated on April 14, 2020
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Posted in BLOG, News
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Leave a Comment on FDA Issues Emergency Use Authorization (EUA) for Face Masks/Respirators to Expedite Importation into U.S

By - SebastianFeye

FDA Issues Emergency Use Authorization (EUA) for Face Masks/Respirators to Expedite Importation into U.S

Due to the novel coronavirus/SARS-CoV-2/COVID-19 rapid infection rate, as well the viruses ability to create asymptomatic carriers, resulting in major societal disruptions and shutdowns have occurred throughout the world, but nowhere has this pandemic hit hardest than within the health care systems, hospitals and clinics. Due to the enormous surge of critical care, there is a massive demand and shortage

Last Updated on March 5, 2020
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Posted in BLOG
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Leave a Comment on CBD – To Be or Not to Be a Drug? Predicting the Impending FDA Regulations on Cannabis.

By - SebastianFeye

CBD – To Be or Not to Be a Drug? Predicting the Impending FDA Regulations on Cannabis.

This blog post was written following a ReedTech webinar (dated 11.7.2019) which focused on helping companies understand how to navigate the state of Cannabidiol (CBD) regulatory environment. This post is for informative purposes only and to provide guidance to minimize risks when labeling, promoting and selling cannabis-derived products in the US. To date, FDA has approved only one CBD drug

Tagged : cannabis, CBD, FDA, GMP, hemp, regulations

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Tag: FDA

New premarket submission route: FDA’s eSTAR Program from pilot to production by Oct 1, 2023

New Updated 2023 FDA Final Guidance Significantly Changing Premarket Submissions Requirements for Medical Device Software

Artificial Intelligence and Machine Learning Workflow Driving Innovative Medical Device Development

An Overview of FDA Inspections across Drugs, Biologics and Medical Devices

New Medical Device Pathway: Safety and Performance Based Pathway

2020 Over-the-Counter (OTC) Drug Monographs Reform Summary

FDA Issues Emergency Use Authorization (EUA) for Face Masks/Respirators to Expedite Importation into U.S

CBD – To Be or Not to Be a Drug? Predicting the Impending FDA Regulations on Cannabis.