Worldwide FDA Experts for Medical Device, IVD, Pharmaceutical Industries
Worldwide FDA Experts for Medical Device, IVD, Pharmaceutical Industries
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 called Electronic Submission Template and Resource or eSTAR was started as a pilot program to create a collection of questions, text and prompt within a PDF template to guide and standardize users through a highly formatted submission that can easily and efficiently be reviewed by the FDA. Currently, eSTAR is a voluntary process that will become mandatory starting October 1, 2023. It is free to use by medical device applicants wishing to submit a 510(k) or a De Novo to the CDRH but is not to be used for combination products. Although it’s currently free to use, the standard submission fees for 510(k) and De Novo’s still apply. A...
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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 However, in November of 2021, FDA released a new and revised draft guidance document which substantially alters software requirements for 510k submissions by changing terms as well as increasing the scope of the software documentation requirements. Medical device and IVD regulatory professionals need to become fully aware of these changes as they may become effective at any time in the near future and will affect all future premarket submissions containing software. The risk level of software or “Levels of Concern” is the first and most obvious change in the new 2021 guidance, since in the 2005 guidance, FDA identifies three levels of concern: Major, Moderate, or Minor, which are wells understood and defined as: Major: If a failure or latent flaw in the medical device could result directly in death or serious injury...
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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 use. These innovative medical devices are adopting Artificial Intelligence and Machine learning (AI/ML) and Software as a Medical Device or SaMD, where software programs run one or multiple algorithms usually paired with a device or computer which is the main component of a device in the goal of treating, diagnosing, driving or informing clinical management regarding an illness or disease. The typical regulatory framework assumes that once a medical device is approved (Class 3) or cleared (Class 2) by the FDA, that the configuration and performance of the device is consistent and that any significant software change will require a new regulatory submission as it changes the risk profile...
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