Tag: Guidance

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 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 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

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Tag: Guidance

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

New Medical Device Pathway: Safety and Performance Based Pathway

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