The US FDA on 7 October recognized a portion of the Oncology Knowledge Base, or OncoKB, which test makers can use as they work to complete premarket submissions. It’s the first database of somatic variants in cancer to be listed in the agency’s Public Human Genetic Variant Databases.
Diagnostics developers now have another tool backed by the US Food and Drug Administration that they can lean on as they work to complete premarket submissions to the agency.
The FDA on 7 October recognized part of a tumor mutation database compiled by the Memorial Sloan Kettering (MSK) Cancer Center. The Oncology Knowledge Base, or OncoKB, is the first database of somatic variants in cancer to be listed in the agency’s Public Human Genetic Variant Databases (PHGVD).
For this “man on the street” feature, Medtech Insight rounded up industry experts Kim Trautman, Vincent Cafiso, Steve Niedelman, Kwame Ulmer and Josh Levin to answer six questions about the upcoming draft harmonized Quality System Regulation from the US FDA.
Author: Suzanne Broussard, PhD | January 5, 2021
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.
(more…)Author: Suzanne Broussard, PhD | November 9, 2020
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.
(more…)Author: Suzanne Broussard, PhD | November 2, 2020
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.”
(more…)This white paper outlines strategies for the verification of device safety and performance as well as tips to define parameters to determine the acceptability of benefit-risk.
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).
This white paper is a companion piece to our popular webinar where we share our insights on using the Systematic
Literature Review (SLR) to Empower Data-Driven Decisions in your Organization.
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.
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.
This white paper is a companion piece to our popular webinar where we break down the steps of the systematic literature review (SLR) process and take a wholistic approach to conducting an In Vitro Diagnostic Regulation (IVDR)- compliant SLR.
This white paper is a companion piece to our popular webinar where we cover the state of the art process and how it
fits into the In Vitro Diagnostic Regulation (IVDR).
Fill out this form, or contact us at info@criterionedge.com, and we would be happy to answer any of your questions as well as book you an appointment to discuss your project needs during a time that works for you.
In this discussion, we provide an overview of how to plan and coordinate change within an organization to meet upcoming EU IVDR regulatory requirements. We will be highlighting key steps involved in helping medical affairs transition to a more rigorous regulatory environments, and how to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.
This white paper is a companion piece to our popular webinar where we share some of the best approaches we have
discovered for Corporate Scientific Communication Strategies.
In this discussion, our panel of proven leaders discuss the key elements that support and propel the innovation process in the medical device, pharmaceutical, and IVD industries. We will be highlighting key areas of the process, important players in the pathway to the market, and how successful innovations spawn new innovations in new markets such as the digital health space, and more.
This white paper is a companion piece to our popular webinar that uncovers what we have learned from our experience in writing Medical Device Regulation (MDR)-compliant Clinical Evaluation Reports (CERs), and how urgently applicable some of these key learnings are in preparing a robust Performance Evaluation Report (PER).
This white paper is a companion piece to our popular webinar where we share some of the biggest issues we have discovered when starting a Clinical Evaluation Report (CER) project, and how to anticipate and avoid project delays.
This companion piece to our popular webinar discusses strategies for assessing key components of your CER like clinical data sources and risk-benefit analysis.
This white paper outlines strategies to assess your CER including state of the art, safety and performance criteria, equivalence and systematic literature review.
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 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.
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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