SaMD FDA: AI & Emerging Technologies

Lisa Michels, General Counsel and regulatory affairs expert at Regulatory Compliance Associates® Inc., discusses regulatory strategies for software as a medical device (SaMD), artificial intelligence and other emerging technologies. She presents insights on working with regulatory bodies on novel devices such as artificial intelligence, machine learning and algorithms.


Artificial Intelligence


When powerful new technologies emerge, unbridled excitement often reigns. The possibilities are endless and markets are undoubtedly huge. Artificial intelligence and machine learning in medicine are at an early stage and the potential to improve medical care is solidifying. Many opportunities are being pursued including enhancing and supporting the decision-making process of physicians, individualizing patient care with precision medicine and using near real-time information to improve care.


AI in Healthcare


Early ideas such as wearables that monitor activity levels or heart rate have been on the market for some time and have mixed results as tools for patient health management. Technology platforms such as Watson from IBM have shown amazing capabilities. AI- related applications have progressed to a point where formal medical device development is occurring, but challenges remain.


Innovators are often fearless and can be blind to the real risks and business difficulties to commercialize emerging technology. On the other hand, the mainstream medical device community can perceive that innovation exposes threat of the long-timelines, high-costs and painful failures. The reality is probably in between both extremes and risk can be mitigated with a deliberate approach to regulatory strategy.


Regulatory Challenges


Regulatory requirements require transparency and regulators need to understand how and why a result came about. Many AI applications are a black box with little transparency and daunting complexities. AI applications can produce valid conclusions that are counter intuitive to those which individuals or even teams of experts derive. Traditionally to gain marketing clearance for a medical device, substantial equivalence to a predicate device needs to be demonstrated.


Artificial Intelligence in Healthcare


Regulators review and clear a device as a system that will not change without considerable deliberation; in fact, manufacturers go to great lengths to ensure that a device manufactured years after initial clearances demonstrates the same performance as the original device. However, one of the more powerful aspects of some AI applications is that the accuracy of output information can continually improve with continued use. This will produce a perpetually dynamic system by design. There are solutions to this dynamic situation.


Making applications as seamless as possible is where the challenges and opportunities are. Independent demonstration of the safety and effectiveness of the dynamic system through the Pre-Market Approval (PMA) process could be necessitated, albeit this regulatory path is much more costly, complex and difficult.




The FDA and industry has since finalized a new medical device user fee agreement that lays out the application process and expectations regarding medical devices being submitted for regulatory approval. The agreement calls for:


  • A new digital health unit overseeing Software as a Medical Device (SaMD) and software inside of medical devices (SiMD)
  • Opportunities to support 510(k), premarket approval and clearance pathways tailored to SaMD, SiMD, and take into account real world evidence
  • Participation in international harmonization efforts for digital health initiatives




1. Strategy begins with build your case, if regulators cannot or do not yet understand a technology, they will struggle to establish ways to assess the safety and effectiveness of your product.


  • Find clinical and regulatory information throughout the world that is supportive of what you are trying to achieve. If negative information is uncovered, do not ignore it; instead, address it.
  • Do not plan on submitting a “black box.” Spend the time to develop ways to communicate how and why a particular result comes about.
  • Seek related credible sources, publications, guidance documents and experts, reference them, and utilize them.


2. Plan on early and frequent meetings with regulatory authorities. Gaining regulatory clearances for emerging technologies benefits from building solid working relationships with regulatory bodies. These relationships are built over a series of meetings that begin early in the development process, aiding both parties as they learn together.


Regulatory Communication


These early collaboration meetings provide a venue for industry to explore new ideas through regulatory communication. Based on working with many novel products, we recommend the following considerations, particularly in working with the FDA.


  • Start with a solid pre-submission package. Make certain to follow established guidelines for pre-submissions, setting the tone that your organization has done its homework. Additionally, a complete pre-submission package enables regulators to prepare for the meeting and identify the appropriate experts needed.
  • Be ready for questions surrounding mechanism of action. In traditional medical devices, a key component of the submission surrounds the mechanism of action, or how the device is perceived to work. Be prepared to explain what your novel technology does and how it does it.
  • Prepare for the meeting. Before the meeting or teleconference, identify your question areas and structure your questions to get the specific information needed without using open-ended formats. Avoid introducing new information that the FDA is not prepared to discuss.
  • Set an open tone during the meeting. Be transparent about the information you have and the areas that are lacking. In early development cycles, gaps exist and it is important to be candid so you get accurate early feedback. Set aside any fears that your organization is setting precedent by not having complete information and instead, work to close those gaps as you progress through the product development process.
  • Set specific but realistic expectations for meetings. Your device is novel and that means regulators have not seen anything like it before. Expect regulators will have questions that will be challenging to answer. Remember, agencies can only provide feedback on what you have presented–what your device is currently– and not what you hope it will be in the future.
  • At all times, be professional and seek to understand their questions. Early collaboration around emerging technologies is a two-way street. When you provide information the FDA needs, they will provide direction to guide your product development. And remember, the agency is a resource. Be open to the answers you receive, so your processes can evolve and improve.


Regulatory Assets


There are cultural differences that exist between the Silicon Valley visionaries that are pushing novel technologies forward versus the deliberately cautious, stepwise approach taken by traditional medical device development teams. In advance of nearly any new, disruptive technology being adopted by broader medical establishments and nearly always in advance of solid profitability.


These teams of brilliant visionaries must still possess the regulatory assets needed to receive FDA approval. Data science has been embraced by many regulatory agencies and included in traditional medical device development organizations.


Application Developer


  • Build effective multidisciplinary teams by addressing cultural divides. When building regulated medical products based on AI, organizations will benefit from vertical structures. Software engineers must connect with key leaders from the company early in the development cycle.
  • Building SaMD medical device products requires deep subject matter expertise. Combining subject matter with technical expertise and embracing the multidisciplinary approach drives innovation, making it possible to accurately model the vision, answer the key questions and realistically hold leaders accountable for results. Team evolution needs to be intentional and designed.
  • If you are unable to set the joint domain early, one side dominates, and it becomes a challenge to bring in world-class experts from the other side. Top people recognize such unbalance and the byproduct that they will not achieve the parity in authority and respect.


Regulatory Compliance Software


Creating solid regulatory affairs teams with prior experience in addressing uncertainty surrounding quality systems and regulatory approval, specifically:


  • Members who understand quality management system compliance for ISO 13485 & 21 CFR 820.  
  • Members with a focused subject matter expertise in the AI/machine learning space and the mindset/ability required to work in a highly complex multidisciplinary environment.
  • Regulatory expertise introducing and gaining FDA clearance or approval for new technologies and with the intention and ability to communicate with the developers.
  • Direct expertise developing software for medical devices and developing and managing quality systems for software development.
  • Where clinical trial work is required, the CRO and strategic regulatory experts need to work closely together to generate the type of clinical data that supports the safety and effectiveness of the underlying product. Also the regulatory team needs to develop and conduct the studies in ways that bring transparency and simplify the “black box” aspects of the product.


Executive Summary


  • Embrace and enforce the multidisciplinary approach.
  • Break down the problem and bring subject matter experts to the table to solve each.
  • Beware of thinking you can do all. Inventors and software developers are uniquely brilliant but not necessarily the best at navigating regulatory challenges.
  • Don’t assume the person with the most RA experience should lead the FDA strategy. The RA and especially QA mindset can limit creativity and curiosity that propels novel technologies forward. QA is a support mechanism to the RA strategy.
  • Leverage working with RA SMEs experienced in emerging technologies and with prior nontraditional submissions.


About RCA’s Medical Device Consulting Services


The regulatory compliance process surrounding the medical device industry involves a strict adherence to pre/post market information throughout a device’s life-cycle. Even a single compliance issue you have can turn into a significant effect on your business. Regulatory Compliance Associates medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.


Our team of over 500 medical device consulting Experts — including former FDA officials and regulatory compliance leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. Regulatory Compliance Associates works with international Fortune 100 companies, venture capital start ups, and companies of all sizes and shapes. our compliance enforcement solutions for law firms include remediation for warning letters, FDA 483’s, import bans or consent decrees. Very few regulatory compliance services have the same regulatory compliance expertise in a variety of medical fields.




For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if Regulatory Compliance Associates medtech consultants do not implement good IoT cybersecurity and FDA cybersecurity protocols.


At Regulatory Compliance Associates, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks. With a well-planned design, along with full visibility of product development and the supply chain, Regulatory Compliance Associates medical device consultant Experts can help strengthen your device’s cybersecurity. We partner with medical device companies in each phase of the design cycle, including protecting inputs from threat exposure and hardening outputs for regulatory compliance & FDA submission approval of your medical technology.


Regulatory Affairs


Regulatory affairs is Regulatory Compliance Associates® backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. Our regulatory compliance consulting Experts have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.


As a trusted regulatory affairs consultant, our FDA veterans and industry experts represent Regulatory Compliance Associates® as one of the top medical device consulting firms. We’re here to help you navigate the difficulties associated with new product submissions. Regulatory Compliance Associates® medical device consulting company has expertise in both the approval process and post-approval support. 


  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR
  • Combination Products


Compliance Assurance


Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® can help.


Our network of over 500 medical device consultant & FDA, MHRA & EMA veterans are industry professionals offers a unique blend of expertise. This allows Regulatory Compliance Associates® to handle both simple and complex regulatory compliance challenges within medical device consulting companies.


  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response
  • Data Integrity


Quality Assurance


Regulatory Compliance Associates® Quality Assurance consulting includes quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Each Regulatory Compliance Associates® medical device consultant is a quality expert with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.


In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At Regulatory Compliance Associates®, we offer you the quality assurance services you need to monitor these processes and ensure quality compliance every step of the way.


With more than 20 years experience working with medical device consulting companies, Regulatory Compliance Associates® trusted medical device quality assurance consultant team is fully equipped to handle your unique QA needs.


  • ISO13485 
  • 21 CFR 210
  • 21 CFR 211
  • Outsourced Staffing
  • Facility Validation
  • Equipment Validation
  • Quality Metrics


Remediation Support


Regulatory Compliance Associates® is widely recognized within medical device consulting companies & the life science industry for remediation support. Regulatory Compliance Associates® ability to help companies successfully resolve complex regulatory challenges have a proven track record of success. Our medical device consulting services include significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.


  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services


Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our medical device consultant expertise and experience that makes partnering with Regulatory Compliance Associates®  a competitive differentiator in the remediation space.


  • Quality System
  • Technical File
  • Design History File
  • Data Integrity
  • cGMP


Strategic Consulting


Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates® medical device consultancy can help ensure a successful project. Regulatory Compliance Associates® medical device strategy consulting can deliver your project on time, on budget, and you’re never embroiled in a costly mistake.


Our medical device consultant Experts are industry Experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.


  • Manufacturing Optimization
  • Product Lifecycle Management
  • Mergers & Acquisitions (M&A)
  • Due Diligence
  • Device Vigilance
  • Risk Management Plan
  • Product Complaints
  • Medical Information


About Regulatory Compliance Associates


Regulatory Compliance Associates® (RCA) provides medical device consulting to the following industries for resolution of life science challenges:



We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.


As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.


  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021


About Sotera Health


The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.


Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.


We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.


Commitment to Quality


Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.


To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 


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