Author: Suzanne Broussard, PhD
The increasing number and complexity of medical devices with several functions prompted FDA to provide medical device manufacturers with premarket and postmarket regulatory guidance. In a nutshell, FDA states that it shall not regulate non-device functions of a product with multiple functions – but can consider the impact of non-device functions on the device functions. The guidance identifies the principles and premarket review practices, postmarket requirements, and multiple examples of the application of the policy.
The term “multiple function” device was first officially addressed by FDA in the 21st Century Cures Act Section 3060 that amended the Federal Food, Drug, and Cosmetic Act (FD&C Act). The guidance amended the definition of “device” removing certain software functions (medical and decision software support) and clarifies which software functions (analyze or interpret medical data) remain under FDA’s oversight.
The Multiple Function Device Products: Policy and Considerations Guidance for Industry and Food and Drug Administration extends that policy to the assessment of all multiple function device products, whether those functions are hardware-based, software-based, or both.
The guidance document is intended to clarify FDA’s policy approach to all multiple function devices, considerations for the design and risks of multiple function device products, and impact assessment of non-device software functions or “other functions” on safety and effectiveness. Furthermore, the guidance provides recommendations on the premarket submission content FDA expects for a device function that is part of a multiple device product. Modifications and postmarket requirements are also addressed.
The policy is risk based with a functionally focused approach to software that is platform independent. The regulation is narrowly tailored to the device’s risk based on the function with the ultimate intent to protect patient safety.
In the guidance, FDA clearly delineates “other functions” and device function-under review.
To begin, FDA defines function as a “distinct purpose of the product” and further clarifies that function could be the intended use or a subset of the intended use of the product. For example, a device with the intended use of storing, transferring, and analyzing data has three functions while a device with the intended use of analyzing data has only one.
“Other function” is considered a function that:
Multiple function devices are comprised of functions that are subject to FDA’s regulatory oversight and “other functions” that are not.
Device function-under review is defined as a function for which FDA is conducting premarket review.
The guidance clarifies that while “other functions” that are part of a multiple-function device are not the subject of FDA review, FDA may assess the impact of “other functions” when conducting the premarket review to determine the devices safety and effectiveness.
“Other Functions” Should be Separated in Design and Implementation
FDA considers the separation of functions of the device-under-review from “other functions” important for risk control. Ideally, the separation occurs early in the design with a higher degree of separation allowing for easier review of the independent safety and effectiveness of the devices function.
Making architecture decisions early in the design cycle that facilitate risk control especially allow for the evaluation of optimal separation and support segregation of:
This separation is considered “especially important when considering cyber security risk and mitigations.”
The guidance outlines the following as critical for manufacturers to consider regarding the impact of other functions.
When separation cannot be achieved, the interconnectedness and interdependencies of the devices function and “other function” needs to be included in the hazard analysis. Furthermore, an appropriate control must be created.
FDA is clear on how it intends to assess the impact of “other functions” and provides a flow chart to guide manufacturers through the assessment.
Manufacturers need to conduct a risk assessment to determine if the “other functions” impact the safety and effectiveness of the device under review. The other functions could act to have a positive effect or an adverse effect.
A two-step process summarizes the premarket assessment.
First, is there an impact on the Safety and Effectiveness of the device function-under review as a result of the “other function?” If yes, could this be a negative impact, meaning an increased risk or an adverse effect on performance of the device function under review?
Positive impact assessments must include the beneficial impact of “other functions” on the device-under-review when the device is operating as intended. In addition, the manufacturer must confirm that the “other functions” do not impart an adverse impact if the device-under-review fails to operate as intended.
Negative impact assessments must identify the potential for an increased risk and/or adverse effect on performance “due to the combination of the other function with the device-under-review.
“Other functions” that impact the device under review must be evaluated and included in the hazard analysis.
Manufacturers need only added other functions to the submission if the positive effects are represented on the device label – a labeled positive impact – or if it may negatively impact the device that is under review.
The FDA provides 7 examples of multiple function device products in Appendix 1. The examples provide a description of the product, product functions (see list below), description of the impact of the “other function” on the device function-under-review and an explanation of the impact assessment.
Below is a list of the hypothetical example device products. See the guidance for details on impact assessment.
The guidance applies to post-market regulations and implicitly states that device functions must comply with design control requirements and expectations surrounding adverse event reporting.
FDA reinforced its position that it does not intend to “enforce general control requirements for device functions for which FDA has expressed its intention to not enforce applicable regulatory controls at this time.”
Multiple function device products that have undergone modifications of the “other function” must be assessed to determine if the change has the potential to significantly impact the safety or effectiveness of the device function that was the subject of FDA review.
This guidance document was written to clarify current regulations as well as to promote innovation and patient engagement with digital health products.
To catch up on FDA’s newest premarket guidance documents see our previous post on Nuances of Using the Safety and Performance Pathway for Submitting a 510(k) for Certain Device Types and FDA Experts Provide Tips to Eliminate eCopy Holds for Premarket Submission Applications: FDA Touts eSTAR Development.
The generation of technical documents that are required for medical device premarket approval requires time and expertise. Consider increases in your company’s efficiencies by working with a team of medical writers that are document experts. At Criterion Edge, we take pride in teaming up with industry experts to provide high quality support. Please reach out to us for a free consult.
Author: Suzanne Broussard, PhD
FDA’s recently finalized modifications to the electronic Medical Device Reporting (eMDR) system include the addition of new fields to harmonize with terminologies set by the International Medical Device Regulators Forum (IMDRF). These changes are designed to “improve transparency and analysis of the MDR data contained in the public Manufacturer and User Facility Device Experience (MAUDE) database” and are part of the FDA’s push for regulatory harmonization.
Device manufacturers now have until February 28, 2021 to use IMDRF codes instead of the retired Patient Problem Codes and Device Component Codes. The original production deployment date of September 7, 2020 was extended to give manufacturers a little more time to adapt to the changes.
The current eMDR reflect FDA’s updates to Form 3500A, which is used by medical device manufacturers, importers, distributors, and user facilities to report diverse events and other system enhancements.
To help manufacturers with a smooth transition to the newest eMDR format, the Center for Devices and Radiological health (CDRH) has created a downloadable file package to assist in implementing software for generating the HL-7ICSR XML for eDMR submissions. And updates on new and retired codes MDR Adverse Codes are easy to find.
The updated eMDR is one of many changes being implemented by FDA. Indeed, 2020 has been an active year for FDA as they work to harmonize across systems.
It takes a team of experts to implement all the regulatory documentations required to get and keep your medical device in compliance, especially ever changing and demanding US and European regulatory requirements.
Author: Suzanne Broussard, PhD
The FDA is moving forward with its commitment to strengthen and modernize the 510(k) program. The Safety and Performance Based Pathway is designed to provide a direct and transparent approach to demonstrating safety and effectiveness of low to moderate risk devices that can meet FDA-identified performance criteria to demonstrate substantial equivalence.
The first device specific guidance documents for Conventional Foley Catheters and Cutaneous Electrodes for Recording Purposes were released in August 2020. More recently, FDA hosted a webinar providing some key points to consider when submitting a 510(k) to the Safety and Performance Based Pathway.
Background information on the Safety and Performance Based Pathway and guidance documents can be found here.
Below is a summary of the nuances that FDA wants your organization to consider if you are in the process of submitting a 510(k) or are considering submitting a 510(k) for well-understood Class II devices through the new Safety and Performance Pathway for Certain Device Types.
First, manufacturers must determine if the device is appropriate for the pathway. The scope of each device-specific performance criteria guidance identifies device types that are appropriate. The guidance indicates which performance device-specific criteria need to be meet, and all criteria outlined must be met.
Secondly, it is still necessary to identify an appropriate predicate for your submission, even though it is not necessary to conduct side by side performance testing of the subject test to the predicate device.
Third, new submissions through the Safety and Performance pathway are evaluated through the same 510(k) substantial equivalence decision flowchart as before. What is unique about this pathway is that to demonstrate performance the subject device must meet all of the FDA identified criteria listed in the device specific guidance. FDA believes this is important as criteria to appropriately determine substantial equivalence “when the indications for use and technological characteristics do not raise different questions of safety and effectiveness from that of the predicate device. And, that the criteria align with one or more predicates of the same device type.”
The determination for whether a device is appropriate of the Safety and Performance 510(k) pathway is typically made during the RTA review stage. During the RTA review stage, if the submission does not have sufficient information or does not meet the criteria there is an opportunity for conversion to another viable 510(k) pathway. However, the conversion may necessitate additional testing that includes a predicate device.
The FDA offers Q-Sub as an opportunity for manufacturers to obtain FDA feedback prior to an intended submission. These meetings are voluntary but can provide valuable insights for manufacturers on both potential and planned medical devices, as well as biologics and drug submissions. The Q-sub meetings are a great avenue to ask FDA questions, gain valuable feedback, and get a documented formal response that can be of future use.
The Q-Sub process can also be used which test methods outside those recommended by FDA are appropriate to meet the identified performance criteria.
Additionally, Q-Sub can be used if additional testing that your organization identified outside of the guidance is necessary to demonstrate the devices safety and performance on a case-by-case basis. The example FDA provided regards adding language to labeling in cases where performance testing is not included in the device-specific guidance. Under this circumstance, additional testing is required.
FDA also included a list of the following resources:
Getting these technical documents together for any 510(k) submission takes expertise and time. Criterion Edge has experience medical writers that can provide support developing and producing your devices 510(k) submissions or pre-submissions. Please reach out to us for a free consult.
Author: Suzanne Broussard, PhD
The Premarket Notification 510(k) Program is the pathway used by manufactures of low- to moderate-risk devices that are substantially equivalent to a device already on the market. Device manufacturers can submit 510(k)s as Traditional, Special, or Abbreviated. See our previous post for an overview of the 4 guidance documents released by FDA in September of 2019.
The Safety and Performance Based Pathway Guidance for Conventional Foley Catheters and Cutaneous Electrodes for Recording Purposes are the first device type guidance documents release by FDA for the expanded Abbreviated Premarket Notification 510(k) Program. This pathway sets the stage for device manufacturers to use performance measures in place of direct comparisons against predicate devices. The direct use of performance measures for devices that qualify for the abbreviated 510(k) Safety and Performance Based Pathway is expected provide manufacturers with substantial savings of both time and resources.
The Safety and Performance Based Pathway, as an expansion of the Abbreviated 510(k) pathway announced by FDA in February of 2019, is designed to be used for well understood device types. Follow the link below for specific information on the program.
Safety and Performance Based Pathway
Certain class II moderate risk devices are able to use the Safety and Performance Based Pathway to gain clearance for marketing if they can demonstrate that they meet FDA’s modern performance criteria. Under these criteria, the device must be demonstrated to be as safe and effective as other devices of the same type that are already on the market that conform to the FDA-identified performance criteria. The Safety and Performance Pathway is appropriate when FDA has determined:
A guidance document was released in September 2019 that describes the optional pathway and provides “FDA’s current thinking on expanding the concept of the Abbreviated 510(k) program for demonstrating substantial equivalence for premarket notification (510(k)) submissions.”
Safety and Safety and Performance Based Pathway
Guidance for Industry and Food and Drug Administration Staff
This newest expansion of the Abbreviated 510(k) Program provides device manufacturers the option to use the performance criteria proposed in the guidance to support substantial equivalence in place of direct comparison of performance of the device to that of a predicated device.
On August 13, 2020, the FDA issued the first final guidance documents for Conventional Foley Catheters and Cutaneous Electrodes for Recording Purposes as part of the FDAs commitment to “strengthen and modernize the 510(k) program.”
Safety and Performance Based Pathway guidance documents are expected to be released by FDA for each device type that qualifies. The first 2 guidance documents for conventional Foley catheters and cutaneous electrodes have similar overall outlines:
The Testing Performance Criteria section clarifies that FDA is asking for a summary of all tests evaluated in addition to the Declaration of Conformity (DoC) for the test specified to “ensure the performance criteria outline in this guidance document remains contemporary and takes into account relevant data from recent clearances.” Furthermore, test information such as results summary, test protocols, or complete test reports need to be submitted as part of the 510(k) as described in the Safety and Performance Based Pathway.
FDA lists 4 additional Safety and Performance Based Pathway guidance document for device types that are currently in draft guidance form and the final guidance’s are expected to roll out in the near future.
The FDA is encouraging industry to become involved in the process. Industry can and should suggest additional device types in which there are comprehensive FDA-recognized consensus standards that correspond with the FDA-identified performance criteria in order to reap the benefits of this Abbreviated 510(k) pathway. In addition, FDA is encouraging industry and other stakeholders to submit evidence-based suggestions on what performance criteria should be for eligible device types. FDA plans to continue to issue draft and subsequent final guidance’s for the Safety and Performance Based Pathway.
Criterion Edge has an experienced team that can provide support for your organization’s risk to benefit analysis and risk management reports. Feel free to reach out to us for a free consult.
FDA’s tips on how to improve Premarket submissions applications and the pending release of the electronic submission program, eSTAR, can be found in our previous post.
The US agency has updated its Medical Device Reporting website with information on which products qualify for its Voluntary Malfunction Summary Reporting program for adverse events, and which don’t.
In this webinar, Dr. Sarah Chavez provides an overview of the State of the Art section, and explains how it fits into the overall process of writing a successful, IVDR-compliant Performance Evaluation Report (PER) in a reasonable time frame. A complete readiness assessment and gap analysis will help you identify critical resources, feeder documents, and expertise needed to establish that your IVD may be considered “state-of-the-art.” Ultimately, knowing what the Notified Body expects to see will help you avoid project delays and discover efficiencies in the SOA development process.
Have the IVDR Performance Evaluation and Post Market Surveillance requirements got you tied up in knots? Where do you start? What does the end product look like? We are joined by the VP of Regulatory, Quality, and Clinical from Nextern, a collaborative medical device company bringing unmatched core competence in medical device product design and development. Criterion Edge’s President Laurie Mitchell will lead a discussion of their experiences supporting clients through MDR and IVDR requirements.
In this practical presentation, President Laurie Mitchell will: 1) discuss how an effective scientific communication plan is an important marketing tool for an organization, and 2) present five strategies to ensure your corporate objectives are supported and maximize the real-world impact of your data. Join us to learn how this applies to your organization and how to implement these strategies into your current processes.
In this practical presentation, Criterion Edge uncovers what we have learned from our experience in writing MDR-compliant CERs, and how urgently applicable some of these key learnings are in preparing a robust Performance Evaluation Report (PER).
As we all know, the MDR has significantly increased both the quality and quantity of inputs needed to complete a CER, needing more up-front planning than the reports have in the past. Based on our experiences with clients both large and small, our President, Laurie Mitchell, shares some of the biggest issues we have discovered when starting an MDR CER project. Laurie also reveals some of the most successful strategies in addressing these issues, up-front and early.
In this practical presentation, Criterion Edge breaks down the steps of the SLR process and takes a wholistic approach to conducting an IVDR-compliant SLR. Using case studies, the presentation illustrates the effective use of SLR-derived data to develop the Scientific Validity Report (SVR) and the Clinical Performance Report (CPR).
In this second installment of our 2-part webinar series, Criterion Edge shares practical presentation to help you assess your CER through the critical lens of a writer and identify possible gaps for mitigation before prior to submission to regulatory authorities.
In this webinar, we share the process of systematic literature review, and discuss the tools and best practices for creating a methodologically-sound systematic literature review.
Watch this video to learn how Criterion Edge is different from the rest.
This infographic goes through 5 key questions to go through in order to control your budget.
Leading industry experts come together to discuss how the MDR affects data management within their respective units.
This report clarifies the modifications to the equivalence guidelines in MEDDEV 2.7/1 and Quality Management Systems (QMS) ISO 13485 standard to help develop strategies.
This gap analysis addresses key revisions to evaluator qualifications and scientific validity in the Clinical Evaluation (CE) MEDDEV guideline rev.4.
The changes to 2.7/1 rev. 4 suggest the need to submit more frequent CERs to regulatory authorities, however, strategies will be discussed for managing the increased requirements.
Every time a healthcare provider makes a notation in the medical chart, a significant and valuable piece of data has been created. This paper discusses the implications of this.
This piece discusses 10 key strategies to building an efficient regulatory writing process.
In this paper, we discuss a prominent clarification on the MEDDEV 2.7.1 rev 4, establishing the “state of the art” section.
The overwhelming turnout at the ‘How to Assess Your CER for MDR Readiness, Part 1’ prompted us to host a live Q+A session where President Laurie Mitchell exclusively answers all your questions.
President Laurie Mitchell returns to continue sharing more about the importance of the systematic literature review.
In this webinar, we share the process of systematic literature review, and discuss the tools and best practices for creating a methodologically-sound systematic literature review.
Establishing and defining state of the art for a medical device is no longer an isolated task – it supports the entire Clinical Evaluation Report (CER). Multiple sections of the MEDDEV 2.7/1 rev 4 compliant CER need to be supported by state of the art data, including safety and performance, risk management, and equivalence.
In this first installment of a 2-part webinar series, Criterion Edge will present strategies for assessing key components of your CER (or CER template) for possible misalignment with significant and applicable MDR requirements.
In this webinar, President Laurie Mitchell discusses why safety reviews are essential in the entire life cycle of product development.
Kyoko Hattori from Criterion Edge returns to discuss best practices for managing the adjudication process in-house, and Brian Kelly from AG Mednet will share how the “JUDI” platform can simplify the management of adjudication.
In this webinar, learn about CECs, familiarization with regulatory guidance, decision factors leading to use of a CEC, and much more.
This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.
Read more about our privacy policy here.
Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings.
If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.
This website uses Google Tag Manager and Pardot's tracking features to collect information such as the number of visitors to the site, and the most popular pages. Keeping this cookie enabled helps us to improve our website.
Please enable Strictly Necessary Cookies first so that we can save your preferences!
