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, on June 14 2023, FDA released a new and revised final 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 2023 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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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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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 other general requirement in the US, OTC drug medicines making up around 60% of all medicines (Prescription (Rx) and Non-Prescription). Developed in 1972, the OTC monograph system has been instrumental in lowering the cost of entry and standardizing requirements across different formulations, however progress in moving forward in adding and amending monographs has not kept up with expectations of the FDA or industry mostly due to an outdated, multi-layered rulemaking process. This caused a large OTC Monograph backlog in which product labels could take years to update. As a response to this, included in the CARES Act, (implemented into law on March 27, 2020) is a major piece of...
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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 OTC (Over the counter) – ex. Hand Sanitizer, API’s (active pharmaceutical ingredients) and homeopathic, herbal and dietary supplements. Who is responsible to for Drug registration and Drug listing? The manufacturer is primarily responsible; however, the Drug importer and/or distributor also has the responsibility for Drug registration. The five process steps for Drug registration and Drug listing : Does your firm have a Duns & Bradstreet (DnB) number (or DUNS number)? If no- go to www.dnb.com where you can initiate the registration for free if located in the US and not time restricted. Obtaining a DUNS number for a foreign firm may take time.Next step, register with FDA for a...
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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 of Personal Protective Equipment (PPE) including surgical and medical gowns, masks, respirators and other critical ventilator equipment. Due to the high number of infections, the need is especially acute in the United States. This is a result of both limited and aged government stockpiles, limited supplies at the manufacturing facilities due to “Just in time” manufacturing, as well as the shutdown of Asian manufacturers during the pandemic. Conversely, during the beginning of the infection in Wuhan, the Chinese government purchased over two billion surgical masks from countries around the world1. But as soon as China and parts of Asia had managed to slow the spread and lower their curve...
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