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A comprehensive scientific communications program is a critical tool for medical device, in vitro diagnostic and pharma companies to raise market awareness for their products. Done well, effective “real-world” communication can position your company as a key scientific leader in its field and drive market adoption and sales. However, ineffective or poorly executed scientific communications can result in lost opportunities to make an early, meaningful and even a positive impact on the market.
In this practical presentation, President Laurie Mitchell: 1) discusses how an effective scientific communication plan is an important marketing tool for an organization, and 2) presents five strategies to ensure your corporate objectives are supported and maximize the real-world impact of your data. Watch to learn how this applies to your organization and how to implement these strategies into your current processes.
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Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?
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: Nupur Srivastava, PhD
The International Organization for Standardization (ISO) 14971:2019 places more emphasis on the risk to benefit ratio of medical devices, asking manufacturers to show that their device is not only safe but also provides a medical benefit. The reference to benefit is included throughout the standard, and the definition for “benefit” is included for the first time.
ISO 14971:2019 Definition of Benefit: a positive impact or desirable outcome of the use of a medical device on the health of an individual, or a positive impact on patient management or public health.
As outlined in the standard, risk has two key components:
The newest ISO 14971:2019 standards emphasize that manufacturers need to demonstrate that the benefits outweigh the risks, as well as mitigating risks. Clause 7.4 of ISO 14971:2019 has even been retitled “Risk/Benefit Analysis” to align with regulatory changes.
Examples “benefits” provided ISO 14971:2019:
The guidance document ISO/TR 24971:2020 also provides clarification and examples of risk-benefit decisions. The TR 24971 provides three-page guidance on figuring out benefits and includes examples. The draft standard comprehends that manufacturers can change a product only if residual risks offset the benefits.
Industry expert and convener of ISO Technical Committee 210 and Joint Working Group 1 (TC210/JWG1), Jos Van Vroonhoven, and a member of ISO TC210/JWG1 and long-time industry expert, Don Powers, provided some insight on what this means for industry in an interview with Medtech Insight. The objective when developing the revision was to keep the reference standard document the same (as much as was possible) while aligning with global regulatory requirements and providing more clarification on how manufacturers can achieve regulatory compliance and provide benefit to patients.
They stressed that manufacturers need to consider that this further guidance on risk-benefit analysis is designed to help in the estimation of anticipated benefits that is based on positive impact on clinical outcomes and related factors. Many factors can influence the risk-benefit balance, such as changes to medical practice, clinical data that confirms additional benefits to patients, change in the patient population that uses the device, and the introduction of other devices on the market.
It is also recommended that manufacturers take a close look at Clause 10 of TR 24971:2020, which is full of helpful post-production information.
In addition to defining benefits, ISO defined residual risk as the “risk remaining after risk control measures have been implemented.”
ISO TR 24971:2020 provides further guidance on benefit-risk analysis, firstly by helping in estimation of anticipated benefits, based on positive impact on clinical outcomes and related factors, and then providing criteria for comparing benefit and risk to find if the overall residual risk is outweighed by the benefits.
“In general, the benefit-risk analysis should not only include theoretical risks and benefits, but rather be supported by objective evidence. The benefit-risk evaluation can be done on individual residual risk or on the overall residual risk,” said Van Vroonhoven.
In summarizing the benefit to risk analysis, Don Powers said companies should look at their overall residual risk, which they will always need to do in comparison to the benefits, regulatory requirements, and all applicable processes based on the guidelines of ISO 14971:2019 and TR 24971:2020.
Regulatory authorities are now demanding that the balance for medical devices must favor the benefits and device manufacturers must conform to ISO 14971:2019 over the next few years if they have not done so already.
Criterion Edge has a team of expert medical writers available to help your organization with Risk to Benefit Analysis in the Risk Management Reports and integration throughout the MDR and IVDR documents as you get ready to meet these new global regulatory challenges. Please reach out to us for a free consult.
Author: Nupur Srivastava, PhD
There has been a lot of discussion on the updated International Organization for Standardization (ISO) 14971:2019, and experts agree that medical device manufacturers need to perform a gap analysis and create a cross-functional team to meet these risk management requirements.
Risk management plays a critical role in getting medical devices into the market, and ISO 14971:2019 “was designed to better align with medical device regulations around the world.” The global regulatory landscape has been very dynamic around the areas of risk management, as well as safety and performance.
Two experts shared insights during an interview with Medtech Insight. Jos Van Vroonhoven, convener of ISO Technical Committee 210, Joint Working Group 1 (TC210/JWG1) and a senior manager for standardization for device giant Philips Healthcare, and Don Powers, a member of ISO TC210/JWG1 and long-time industry expert, said that the third edition of ISO 14971 provides more precise guidance and greater detail in the application of risk management concepts.
These experts provided specific tips on how to transition ISO 14971:2019 into your device’s quality systems.
Since ISO 14971:2019 instructs manufacturers how to best put together risk management programs, this is a good time to review risk management procedures and perform Gap Assessments.
Create another team to evaluate residual risks. This group needs to form a cross-functional team of experts with application and clinical knowledge that can provide good judgment for the residual risk of the medical device.
The example provided explored the residual risk of x-ray equipment. In this case, the residual risk team might be comprised of individuals with expertise in the following areas.
The standards outlined in ISO 14971:2019, like benefit-risk analysis, are now in demand by global regulators.
The ISO 14971 standards were updated in 2019 in the United States and the European Union to conform to the higher expectation of identifying and mitigating risks associated with a medical device throughout its lifecycle.
In the US, FDA requires device manufacturers to align with ISO 14971:2019 by the end of the transition period December 25, 2022, after which time FDA will no longer accept the previous ISO 14971:2007 version.
In Europe, ISO 14971:2019 (EN version) aligns with the Medical Device Regulations (MDR) and In Vitro Diagnostic Regulation (IVDR) safety and performance requirements. Although it is not yet harmonized with these standards, ISO 14971:2019 is expected to become a Harmonized standard, which will make it state-of-the-art. The date of application for MDR (26 May 2021) and IVDR (26 May 2022) is quickly approaching.
Globally, ISO 14971:2019 is considered the international standard for risk management and is referenced, if not endorsed, by all other major markets that require the application of risk management including, Australia TGA, Brazil, Health Canada, and Japan MHLW.
Therefore, device manufacturers must begin to transition into compliance with the revised version of ISO 14971:2019 to align with global regulations.
For more information on Quality Management Systems (QMS) ISO 13485 standard, see our white paper: MedDev 2.7/1 Guideline: Equivalence and Risk/Benefit Profile
For updates on MDR and IVDR, see our previous posts:
The Deadline for Compliance with MDR 2017/745 is Extended to 26 May 2021: Changing and Challenging Dynamics
The Second Corrigendum of Medical Device Regulation (MDR) 2017/745 Offers Manufacturers a 4-Year the Grace Period for Eligible Class I Medical Device
MDD or MDR? Medical Device Manufacturers Are Faced with a Big Decision Going Forward Under the MDR Extension
The Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR) Mandate Manufacturers Have a Person Responsible for Regulatory Compliance (PPRC): Guidelines and Support
IVDR 2017/746 Implements Risk-Based Classification of IVDs that Focuses on Intended Use
Key Changes in the Regulatory Requirements for In Vitro Diagnostic Devices Marketed in the European Union Under IVDR 2017/746
The first edition of ISO 14971 was released in 2000 to assist manufacturers, regulatory bodies, and healthcare providers in managing the medical devices’ potential risks. This picture depicts the evolution of ISO 14971 from 2000 to 2019.
Get a copy of the slides from this webinar or click to watch the recording.
With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. 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).
Who should watch this webinar?
Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Performance Evaluation Reports for EU IVDR submission, or anyone interested in learning more about IVDR requirements for PERs.
Sign up for future webinars here.
Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?
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.
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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.
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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.
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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.
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