Tag

fda
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...
Read More
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...
Read More
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.
Read More
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...
Read More
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...
Read More
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,...
Read More
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,...
Read More
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...
Read More
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!
Read More
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,...
Read More
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...
Read More
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...
Read More
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,...
Read More
The FDA and the NIH National Center for Advancing Translational Sciences (NCATS)/Office of Rare Diseases Research (ORDR) conducted this needs assessment to better understand unmet medical device needs for rare diseases – ultimately to raise public awareness of these unmet needs.  Let this motivate us all to explore, push limits, innovate, and invent.  Onward software...
Read More
One of the first steps on the marketing pathway for a medical device is to classify your device. As technology and innovation continue to advance, determining how to classify a device can be complex and challenging. This session will provide information on interacting with FDA for device determination and an introduction to Section 513(g) Requests...
Read More
URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Devices The U.S. Food and Drug Administration (FDA) is informing patients, health care providers and facility staff, and manufacturers about cybersecurity vulnerabilities that may introduce risks for certain medical devices and hospital networks. The FDA is not aware...
Read More
Brian Pate has created this job aid to assist with explaining the separation of design input from the design process.  The diagram illustrates the "flow down" process of high level, intended use functionality traces downward to more detailed requirements and specifications.  Where do we draw the line with design input?  What should be the focus...
Read More
The U.S. Food and Drug Administration released a suite of “Digital Health” guidances. The guidances issued today are a continuation of the Agencies efforts announced as part of the Digital Health Innovation Action Plan and address key provisions of the 21st Century Cures Act. The first guidance announced is Clinical Decision Support Software, a revised...
Read More
Premarket Notifications (510(k)s), Premarket Approval Applications (PMAs), Premarket Reports (PMRs), notices, and supplements all have associated fees to be paid to the FDA before they will review a medical device product. The 2019 Medical Device User Fee Amendments (MDUFA) are listed at 2019 MDUFA. If the FDA determines that a manufacturer is a “small business”...
Read More
Some thoughts on Requirements … using the General Principles of Software Validation to help. Many times we struggle with creating software requirements and documenting them.  The FDA General Principles of Software Validation-Final Guidance helps set the FDA expectations in this area.  Section 4.1 of the guidance states: “A documented software requirements specification provides a baseline for both...
Read More
Cybersecurity issues arise when medical devices are capable of connecting to the Internet or other medical devices. Since the FDA is concerned with regulating the safety and effectiveness of medical devices, manufacturers must ensure that the computer systems of medical devices are protected against security breaches. The link below provides the FDA Fact Sheet entitled,...
Read More
Patient Engagement Advisory Committee Meeting to Discuss Cybersecurity – September 10, 2019 On September 10, 2019 the FDA will hold a meeting of the Patient Engagement Advisory Committee. The committee provides advice to the FDA on complex issues relating to medical devices, the regulation of devices, and their use by patients. During the meeting the...
Read More
Join the FDA and NITRD on July 17 for a Listening Session on Interoperability of Medical Devices On July 17, 2019, the U.S. Food and Drug Administration (FDA) and The Networking and Information Technology Research and Development Program (NITRD) will host a listening session on the interoperability of medical devices, data and platforms. During the...
Read More
The FDA is warning patients and health care providers that certain Medtronic MiniMed™ insulin pumps have potential cybersecurity risks. Patients with diabetes using these models should switch their insulin pump to models that are better equipped to protect against these potential risks.
Read More
FDA announced the next phase of its Pre-Cert Test Plan implementation. Pre-Cert refers to the the pre-certification program that FDA’s Digital Health unit has been piloting. The program targets SaMD devices only at this time. This next phase seeks SaMD companies, willing to volunteer, that foresee a De Novo request or 510(k) submission within the...
Read More
Today FDA issued a final guidance, “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.  Guidance for Industry and Food and Drug Administration Staff Document (May 7, 2019).  The FDA’s Q-Submission Program provides submitters an opportunity to have early collaboration and discussions about medical device submissions. In our opinion, early feedback and...
Read More
In April 2019, FDA released a draft guidance providing manufacturers and FDA staff with detailed recommendations on assessing the technical performance of quantitative imaging devices and how the documentation from those assessments should be provided in premarket submissions. From a big picture perspective, one should remember the overall goal is to “provide performance specifications for...
Read More
FDA’s final “Classification of Accessories Distinct from Other Devices; Finalized List of Accessories Suitable for Class” will be posted shortly at https://www.federalregister.gov/documents/2019/04/12/2019-07290/medical-devices-classification-of-accessories-distinct-from-other-devices-finalized-list-of. While this allows for certain accessories for higher class devices to be exempt from premarket notifications, the preamble has a section worth noting as a reminder for medical devices containing software. The preamble...
Read More
From late 2015 to 2016, FDA and NCATS/ORDR at NIH conducted a needs assessment to better understand unmet medical device needs for rare diseases; generate meaningful data to inform patients, practitioners, policymakers, and device developers on the needs, barriers, and incentives related to medical device development for rare diseases; and increase public awareness of these...
Read More
FDA Regulation of Artificial Intelligence (AI) and Machine Learning in Software as a Medical Device On April 2, 2019, the FDA published a discussion paper “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback” that describes the FDA’s foundation for a...
Read More
The US FDA Center for Biologics Evaluation and Research (CBER) finalized the December 2017 draft guidance titled “Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research” today.  The guidance makes clear that CBER recognizes the value and proper usage of standards and further encourages the...
Read More
Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to alert health care providers and patients about cybersecurity vulnerabilities identified in a wireless telemetry technology used for communication between Medtronic’s implantable cardiac devices, clinic programmers, and home monitors. The wireless telemetry protocol has cybersecurity vulnerabilities because it does not use encryption, authentication,...
Read More
US FDA has proposed a new rule to exempt Cytometry instruments used for counting or characterizing cells (a well-understood and mature technology), from premarket notification requirements.  Cytometry instruments used for sorting or collecting cells, and instruments that are used as an automated hematology analyzer, or that perform automated differential cell counts, will still require premarket...
Read More
Today FDA qualified the Osirix CDE Software Module biomarker test for use by medical device developers to identify and enroll patients into Traumatic Brain Injury (TBI) studies.  This is the third qualification of a medical device development tool (MDDT) by the FDA, and the first of a software module biomarker test tool type. A biomarker...
Read More
Medical Device Development Tool (MDDT) Qualification The US FDA has provided guidance on the methods and approaches to qualify a medical device development tool so that medical device manufacturers or sponsors can use them to support the development and evaluation of medical devices.  The manufacturer is expected to ensure the tool produces “scientifically-plausible measurements” and...
Read More
In January 2018, the U.S. Food and Drug Administration (FDA) issued a safety communication to alert health care providers and patients about a potential problem in the charging circuitry of the Zoll LifeVest 4000, which had the potential to prevent it from delivering a life-saving shock to patients. If the message “Call for Service –...
Read More
For those currently or intending to distribute electronic labeling for their medical devices, be aware that in 2010 FDA issued a guidance entitled “Addition of URL to Electronic Product Labeling”.  This guidance contains a recommendation: “ …that manufacturers include their Uniform Resource Locator (URL) on their electronic product labels in addition to the requirements under...
Read More
The FDA released a Draft Guidance titled “Nonbinding Feedback After Certain FDA Inspections of Device Establishments”, on February 19, 2019.  It provides a very limited set of conditions where companies can request non-binding FDA feedback to the adequacy of planned corrective actions. The request must be submitted within 15 days of the issuance of the...
Read More
FDA issued a version of its “Refuse to Accept Policy for 510(k)s” dated 21-Feb-2019. This supersedes the prior 30-Jan-2018 version.  As FDA guidance goes, this a short period of time between updates.  It focuses on explaining the initial 15 day administrative completeness check, review initial questions, provision of a checklist for this administrative review which...
Read More
On Jan 14, 2019, FDA recognized ANSI AAMI SW91:2018 Classification of defects in health software.  The FDA recognition statement for this standard does not indicate any specific use in premarket submissions or relevant FDA guidances. It simply states it supports existing policies.  This standard is lengthy and technical in terms of its approach to defect...
Read More
The US FDA issued the final guidance for industry, “The Least Burdensome Provisions: Concept and Principles.”  This guidance is intended to accurately reflect Congress’ intent by describing the guiding principles and recommended approach for FDA staff and industry to facilitate consistent application of least burdensome principles.  FDA Least Burdensome Final Guidance
Read More
FDA issued a Safety Communication on January 31, 2019, (see Safety Communication Link) warning of the risk of air being introduced in a blood vessel (air-in-line) and air embolism for infusion pumps, fluid warmers, rapid infusers, and accessory devices.  This communication is directed toward users (both clinical and service personnel) and patients.  However, what can system architects,...
Read More
FDA posted a Stryker announcement today that the company is launching a voluntary field action (VFA) on specific units of the LIFEPAK 15 Monitor/Defibrillators. The company is notifying certain LIFEPAK 15 customers of an issue that may cause the device to lock up after a defibrillation shock is delivered. The lock-up condition is defined as...
Read More
FDA is entering the test phase of its Digital Health Precertification (Pre-Cert) Pilot Program. General information on this program can be found at: https://www.fda.gov/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/default.htm including FAQs at: https://www.fda.gov/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/ucm577330.htm Milestones and next steps can be found at: https://www.fda.gov/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/ucm584020.htm Generally, this program is for some of what FDA refers to as Software as a Medical Device (SaMD). ...
Read More
The Verily Study Watch is a device worn on the wrist that digitizes patient physiologic measurements and processes the raw data through algorithms both on the wrist worn device and additional processing when communicated to cloud based computing systems.  The idea is that the Verily watch would be worn similar (or as!) a consumer device...
Read More
It’s nice to have medical device FDA regulations and guidance accessible without navigating through old websites or lugging printed copies around. Thankfully, SoftwareCPR’s free iOs and Android apps allow you to quickly view medical device regulations and guidance on your smartphone offline! As medical device consultants, we know from experience how important it is to...
Read More
(January 7, 2019)— John F. Murray, Jr, of Mount Airy, MD USA, has joined Crisis Prevention and Recovery LLC (DBA SoftwareCPR ®) as a partner. John retired from the US Food and Drug Administration in December 2018 after 32 years of federal service. For 25 years at FDA, John focused on FDA regulated software and...
Read More
It is always good to remind ourselves of exactly what the regulation says – often our corporate procedures can become “bloated” and lead some to believe that some specific activities and/or types of deliverables are required by the regulations.
Read More
FDA posted a Medtronic announcement today that the company is launching a voluntary field action (VFA) for a software update on Puritan Bennett 980 Ventilators. The voluntary field corrective action is a software update to address customer feedback. The software updates the external USB Drive performance and its impact on Graphical User Interface (GUI) functionality...
Read More
FDA released a new draft guidance today entitled, “Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment Draft Guidance for Industry and Food and Drug Administration Staff“, dated December 17, 2018.  A few things to note related to software: On line 370, question 16, FDA addresses the question of the use of software...
Read More
1 2 3 12

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@softwarecpr.com
for more info!

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.