Blog Postings
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
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
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
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
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,
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
How to Register a Hand Sanitizer Product in the US
Due to the COVID-19 pandemic, world-wide demand has soared for hand sanitizer and anti-viral products. Below, we outline five basic steps for domestic and foreign manufacturers or domestic distributors who want to get their drug product into the US market but never dealt with the FDA’s electronic drug registration and listing. The scope of products includes: Rx (Prescription Drugs) and
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
How to fight the coronavirus SARS-CoV-2 and its disease, COVID-19 – Michael Lin, PhD-MD
A very informative and detailed overview of the SARS-CoV-2 or novel Coronavirus from a Stanford Doctor, Michael Lin, as well as a bonus recipe at end for making hand sanitizer. Links referenced in Slides Slide 3: https://www.cdc.gov/flu/about/burden/preliminary-in-season-estimates.htm Slide 4: https://abcnews.go.com/Health/covid19-days-surfaces-experiment-findings/story%3Fid=69569397 Slide 5: https://www.vox.com/2020/2/14/21135208/coronavirus-wuhan-china-covid-19-name-sars-cov-2 Slide 6: https://www.ncbi.nlm.nih.gov/pubmed/31971553, https://www.ncbi.nlm.nih.gov/pubmed/15280490 Slide 7: http://doi.org/10.1101/2020.03.09.20033217, https://www.ncbi.nlm.nih.gov/pubmed/22312351 Slide 8: https://en.wikipedia.org/wiki/2020_coronavirus_pandemic_in_South_Korea, https://wwwnc.cdc.gov/eid/article/26/6/20-0320_article, https://www.worldometers.info/coronavirus/country/south-korea/ Slide 9: https://cmmid.github.io/topics/covid19/severity/diamond_cruise_cfr_estimates.html, http://www.wsj.com/articles/experimental-drug-helps-some-americans-ride-out-coronavirus-nih-doctor-says-11584094955,
Accurate Consultants Inc. (ACI) provides solutions in the following areas: Clinical Affairs, Compliance Solutions, Auditing and Gap Analyses, Quality System Implementation, Regulatory Affairs and Submissions, Training Solutions, U.S. Agent- Registration
