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The Medical Device Innovation Consortium (MDIC) recently partnered with the MITRE Corporation, Adam Shostack, and the FDA to host a webinar regarding the soon to be released “Playbook for Threat Modeling Medical Devices.” The playbook was created during a series of bootcamps held by the team over the past year and the webinar provided a...
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The FDA CDRH announced the guidance documents they intend to publish in FY2022. They also announced their intention to finalize, withdraw, re-open the comment period, or re-issue a revised draft guidance for 80 percent of draft guidance documents within 3 years of the close of the comment period, and within 5 years of the close...
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September 17, 2021 CMS 617922 Excerpts from a warning letter of interest to software professionals: “The United States Food and Drug Administration (FDA) conducted an inspection of your medical device operations at 200 W. Mercer Street, Suite 500, Seattle, WA 98119 from June 3, 2021 through July 15, 2021. During the inspection, an FDA Investigator...
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FDA’s Digital Transformation and the regulation of Medical Device Cybersecurity? I read the recent FDA post that discussed the FDA’s Digital Transformation: “Today, the U.S. Food and Drug Administration announced the reorganization of the agency’s information technology (IT), data management and cybersecurity functions into the new Office of Digital Transformation (ODT).” Then I was reading...
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You may be interested in attending the FDA Virtual Public Workshop, “Transparency of Artificial Intelligence/Machine Learning-enabled Medical Devices,” planned for October 14, 2021.   Info on attending:  https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/virtual-public-workshop-transparency-artificial-intelligencemachine-learning-enabled-medical-devices  
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The US FDA released the 2022 user fees for certain medical device submissions and establishment registration. On August 2, 2021, the FDA announced the FY2022 user fees in a Federal Register notice titled Medical Device User Fee Rates for Fiscal Year 2022. FY2022 User fees are required for the following types of medical device submissions:...
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One of the most important references in creating a software development lifecycle process to assure software quality is the FDA guidance document, “General Principles of Software Validation.”  This guidance document has been around for many years.  The current version, 2.0, was released in 2002.  To many in the industry, this guidance is simply referred to...
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The FDA released a guidance document on the non-clinical testing and clinical considerations of ‘Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation’. The document can be downloaded from the FDA website. One point of particular interest comes from the software section, where the FDA states that “We generally consider the software for...
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On June 7th, 2021, the FDA updated their database of recognized consensus standards. This update included two new items related to medical device software. These two items are IEEE standards that are relevant to all medical devices that claim interoperability with other networked entities. They are being recognized based on their scientific and technical merit...
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The Food & Drug Administration (FDA) has issued a response to NIST to the Executive Order (EO) on Improving the Cybersecurity of the Federal Government (EO 14028), dated 26 May 2021. The document, Response to NIST Workshop and Call for Position Papers on Standards and Guidelines to Enhance Software Supply Chain Security, summarizes “established FDA practices...
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The FDA’s Office of Science and Engineering Laboratories (OSEL) works to promote the innovation and development of new lifesaving medical devices. Their goal is to use the latest science to expedite the development of medical devices. The FDA would like to bring awareness to the 20 research programs that are in place for the advancement...
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The FDA is officially modifying medical device classifications for some software functions. On April 19, 2021, the agency published a “final” rule that updates eight classification regulations by amending these regulations to exclude software functions that no longer fall within the device definition under 201(h) of the FD&C Act. With this final rule, FDA is amending the...
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(April 6, 2021)— Ginny Kwan Gattinger has joined Crisis Prevention and Recovery LLC (DBA SoftwareCPR®) as a Partner. Ginny is a regulatory affairs professional specializing in software-based products with over 10 years of experience in the regulated industry including medical devices, pharmaceuticals and biotechnology. Ginny has developed regulatory strategies for a variety of SiMD/SaMD and...
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On a recent podcast of Quality Injection Podcast EP12, our General Manager Brian Pate spoke with Oded Assouline on the topic of US FDA Design Controls and in particular Design Input.  Some of the questions they explored were Is a concept phase needed for defining the product or device that meets the user needs. Are validation...
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Devices that do not meet the criteria for the Breakthrough Devices Program may have a new option under the Safer Technologies Program for Medical Devices (STeP). Read our previous post on the the Breakthrough Devices Program here: FDA Breakthrough Devices Program Draft Guidance. SteP is a voluntary program for certain medical devices that are “reasonably...
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Is it possible to view draft revisions of FDA guidance documents when they are a “work in progress,” or are they only become available once published as draft?  This is a frequent question that I have heard. However, the FDA does not typically provide copies or drafts of “works in progress” for those items that...
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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance on EMC entitled ‘‘Electromagnetic Compatibility (EMC) of Medical Devices.’’ This new “draft” guidance document is intended to recommend information that should be provided in a premarket submissions to demonstrate electromagnetic compatibility (EMC) for electrically powered medical devices and medical...
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Why is a SR or NSR Designation important? The FDA guidance document, “Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors: Significant Risk and Nonsignificant Risk Medical Device Studies,” sheds some light on the Investigational Device Exemptions (IDE) regulations of 21 CFR 812. The IDE regulations describe significant risk (SR), nonsignificant risk (NSR), and exempt...
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FDA released their CDRH Proposed Guidance Updates that includes a significant amount of “software related” guidance in FY 2021. There are four separate guidance documents listed for publication in FY 2021. IMO that is a fairly large commitment from the agency and I will look forward to reading about the agency’s “current thinking” on these...
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Medical devices are now considered a subtype of Internet of Things (IoT) devices [(2) https://owasp.org/www-pdf-archive/SecureMedicalDeviceDeployment.pdf]. There is a growing need to properly document the physical off-the-shelf (OTS) subsystem components that a medical device contains. Medical devices are often no longer stand-alone devices which contain only proprietary components. Inattention to additional components may lead to a...
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Understanding OTS and SOUP is very important in every lifecycle stages of medical device and HealthIT software development.  In the late 1990’s, the US FDA first published guidance documentation on the use of Off-The-Shelf (OTS) software in medical devices (or sometimes referred to as “OTSS”).  At that time, OTSS generally accounted for a very small...
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The FDA recently announced the addition of 25 new tools to the Catalog of Regulatory Science Tools to help assess medical devices. CDRH catalogues regulatory science tools on this webpage to help improve the development and assessment of emerging medical technologies. Of the 25 tools added, some items of interest are: Laboratory Accuracy Evaluation of...
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On September 14, 2020 the Digital Health Team at FDA provided a 2020 Update on the Software Precertification Pilot Program. The announcement is a short 8-page document. The document provides the details that are driving program development. It contains a considerable amount of information that may take a few reads to fully understand. On my...
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Do you have a medical device cleared under Emergency Use Authorization (EUA) during the COVID-19 crisis? Section 564 of the FD&C Act allows the FDA to issue EUAs to otherwise unapproved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents...
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Why are clinical studies necessary? Medical device clinical studies provide evidence for a PMA submission. Under 21 CFR 860.7, the FDA relies only on “valid scientific evidence” to determine whether there is reasonable assurance that a device is safe and effective. Valid scientific evidence can originate from a variety of sources, including well-controlled studies. Even...
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Remember the 2005 guidance document, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices? In 2020 that guidance is as relevant as ever, and it can be useful to review what we know about the FDA’s expectations regarding Level of Concern (LOC) in medical devices. LOC is important if for no...
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List of Recently Added 510(k) Exemptions The table above comes from the Federal Register, and it explains the classification scheme (including new product codes) for the new 510(k) exemptions for Class II devices. Clearly, these five exemptions do not have far-reaching implications. This update from the FDA will likely only be significant to our clients...
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Electronic submissions to the FDA will soon no longer be optional – this new guidance requires e-submission for many types of submissions. The FDA final guidance document, Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act, was issued on July 15, 2020. Under...
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Do you understand the Q-Sub Guidance? The FDA issued the guidance document Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program in 2019, but it has taken some time for the industry to understand all the facets of the program. The guidance covers a wide range of FDA submissions – IDE/PMA/HDE applications, de novo...
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On July 16, 2020, FDA issued 510(k) Approval for AI Imaging Analytics Device HealthMammo, a device manufactured by Zebra Medical Vision Ltd. As reported in the New York Times, HealthMammo is an artificial intelligence (AI) product that analyzes mammograms for suspicious lesions. Radiologists can use the HealthMammo results to prioritize which mammogram images need attention...
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This content is only available to our Premium subscribers.  See our Subscribe page for information on subscriptions.   The agency rule list for Spring 2020, accessible at https://www.reginfo.gov/public, announced that the “Medical Device De Novo Classification Process” rule is in the final rule stage. Although the FDA has previously written a guidance document about the...
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June 17, 2020 Excerpts from a warning letter of interest to software professionals: “During our inspection, our investigators observed specific deviations including, but not limited to, the following… 3. Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data and failure to have adequate controls to prevent omission of...
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This content is only available to our Premium subscribers.  See our Subscribe page for information on subscriptions. What is a Real-Time PMA Supplement? Section 737(4)(D) of the Federal Food, Drug, and Cosmetic Act defines a Real-Time PMA Supplement as: “a supplement to an approved premarket application or premarket report under section 515 that requests a...
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(July 13, 2020) Amy Sellers, of Tampa, FL, USA, has joined SoftwareCPR as a Regulatory Associate.  Amy recently received her J.D. from the University of Florida Levin College of Law. She has experience in regulatory pathway decisions, including analysis of intended use and product claims, as well as analysis of design changes against US regulations...
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This content is only available to our Premium subscribers.  See our Subscribe page for information on subscriptions. You are likely aware of the CAPA process overall and how it fits in to the quality management system for a medical device manufacturer or supplier.  Just the name itself, corrective and preventive action, describes one of the...
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Background of the Medical Software Functions Exclusion Most of those in the industry do not question whether the FDA has the authority to regulate software that qualifies as a device. However, there are many intricacies in the definitions of the 21st Century Cures Act – which, in 2016, amended the definition of medical devices in...
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On June 24, 2020, there was an update to the current status of FDA’s MDDT program. CDRH announced a new tool had qualified as MDDT. This is only the sixth tool to qualify since the MDDT Guidance document was finalized in 2017. See the list of qualified tools here: https://www.fda.gov/medical-devices/science-and-research-medical-devices/medical-device-development-tools-mddt.   What is the Medical...
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FDA released a new guidance document titled, “Nonbinding Feedback After Certain FDA Inspections of Device Establishments, Guidance for Industry and Food and Drug Administration Staff.  This guidance was issued on April 22, 2020.  The background on the guidance states, “Timely nonbinding feedback can help device firms determine whether proposed actions to address inspectional observations are...
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U.S. Food and Drug Administration (FDA) issued this immediately in effect guidance: Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID- 19) Public Health Emergency.  FDA believes the policy set forth in this guidance may help address these urgent public health concerns by helping to expand the availability and remote capabilities...
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On February 25-26, 2020 the U.S. Food and Drug Administration (FDA) held a public workshop to discuss the “Evolving Role of Artificial Intelligence in Radiological Imaging.” The comment period for the public workshop is extended to June 30, 2020, in response to requests for an extension to allow stakeholders additional time to submit comments.
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FDA Issues Immediately in Effect Guidance on Ventilators During COVID-19 Today, the U.S. Food and Drug Administration (FDA) issued this immediately in effect guidance: Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease-2019 (COVID-19) Public Health Emergency. The FDA believes the policy set forth in this guidance may help address...
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The US FDA released a new guidance document communicating a new policy intended to expand the use a hospital based vital signs equipment to include home use.  This policy changes is in response to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.  You can download the guidance by clicking this link: Enforcement Policy for Non-Invasive...
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December 26, 2019 Excerpts from warning letter of interest to software professionals: “The inspection also revealed that your … LED light therapy devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage,...
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FDA is raising awareness among health care providers and facility staff that cybersecurity vulnerabilities in certain GE Healthcare Clinical Information Central Stations and Telemetry Servers may introduce risks to patients while being monitored.  Per the FDA notice: “A security firm has identified several vulnerabilities in certain GE Healthcare Clinical Information Center workstations and Telemetry Servers,...
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This "FDA GPSV Traceability Expectations" post is only available to Premium subscribers. See our Subscribe page for information on subscriptions. Going way back to the late 1990's, FDA had an expectation that safe and effective software would require a well thought out development lifecycle that includes many activities designed to ensure the correctness and robustness...
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How do I know if my device or my software is a medical device? Watch this helpful video and learn about the 513(g) process as well.  SoftwareCPR can help you plan your regulatory strategy and handle your regulatory submissions.  We would be delighted to help!
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62304 Public Training Course DATES:  February 4-6, 2020 (REGISTRATION extended through January 18, 2020) COST: 3 Full Days for $2,595.00 (Registration extended through 1/18/2020) Volume Discount:  $450 off for 4 or more students from same company Register Now:  https://events.eventzilla.net/e/2020-softwarecpr-62304-and-emerging-software-standards-training-course–sunnyvale-ca-2138757731 This 62304 Public Training Course provides a clear understanding of the 62304 standard for medical device software,...
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Thus far, regulatory guidance for medical device cybersecurity has been focused on the approval or compliance of the device itself and has not been very specific about what cybersecurity assurance information is provided to the health care customers that host the devices within their IT infrastructure.  Medical device labeling has been sparse related to cybersecurity...
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Do you have a question about FDA Digital Health Regulatory Policy?  FDA’s Center for Devices and Radiological Health has a resource to help. I know from personal experience that the Digital Health Team (DHT) at FDA focuses a lot of energy and effort on answering these questions in an effective and efficient manner. During my...
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This new draft guidance explains when a Type V DMF may be used to submit information regarding a combination product for which the Center for Drug Evaluation and Research (CDER) has primary jurisdiction (i.e., CDER-led combination product) and the device portion has electronics and/or software that is planned to be used as a platform, that is,...
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