Worldwide FDA Experts for Medical Device, IVD, Pharmaceutical Industries
Worldwide FDA Experts for Medical Device, IVD, Pharmaceutical Industries
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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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 statutory authority.” (Compliance Policy Guide Sec 130.100) This means that FDA does not require consent to conduct an inspection and that any firm that registers with the FDA for the manufacture of either Drug, Biologics or Medical Devices will likely be subject to an inspection at some point. The U.S. Food and Drug Administration’s Office of Regulatory Affairs (ORA) is the lead office for all agency field activities. ORA inspects regulated products and manufacturers, conducts sample analyses of regulated products and reviews imported products offered for entry into the United States. ORA operates on a risk-based approach, meaning they will prioritize their inspection schedules on those higher risk regulated...
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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, as well as defined performance criteria to demonstrate the device is as safe and effective as a legally marketed device. Under the approach expanded in the Safety and Performance Based Pathway guidance, a submitter could satisfy the requirement to compare its device with a legally marketed device by, among other things, demonstrating that the device’s performance meets established performance criteria. These performance criteria are derived from FDA-recognized consensus standards, FDA guidance’s, scientific literature, special controls and historical 510(k) submission data. In all 510(k) submissions performance data is critical to proving a state of substantial equivalence to a predicate device and is often the most time consuming and complicated part...
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