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Mar

COVID-19 Public Health Emergency – FDA Ventilators

March 22, 2020Alan KusinitzNews

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...

Mar

COVID-19 Public Health Emergency – FDA Telemedicine

March 21, 2020John MurrayNews

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...

Feb

Warning Letter – Software Validation Shortcomings

February 26, 2020Brian PateNews

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,...

Jan

Cybersecurity Vulnerabilities – GE Healthcare Clinical Information System

January 23, 2020Brian PateNews

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,...

Jan

FDA GPSV Traceability Expectations

January 23, 2020Brian PateBlog, Prem

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...

Jan

How do I know if I have a medical device?

January 16, 2020Brian PateNews

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!

Jan

62304/FDA Public Training Course – SF Area – Feb 4-6, 2020

January 16, 2020Brian PateNews

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,...

Nov

FDA’s Digital Health “Ask A Question” Portal

November 14, 2019John MurrayBlog

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...

Oct

New CDER Guidance on Platform Software

October 29, 2019Brian PateNews

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,...

Oct

2018 FDA-NCATS Report on Unmet Medical Device Needs

October 24, 2019Brian PateBlog

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...

Oct

FDA Workshop on 513(g) Requests – Nov 5, 2019

October 15, 2019Jordan PateNews

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...

Oct

IPnet Cybersecurity Vulnerabilities – Urgent

October 1, 2019Brian PateNews

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...

Sep

Enhanced V Model Diagram

September 28, 2019Jordan PateNews

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...

Sep

FDA Releases Digital Health Guidances

September 26, 2019John MurrayNews

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...

Aug

Breakdown of FDA’s Medical Device User Fees

August 7, 2019Amy SellersBlog

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”...

Aug

FDA Expectations for Requirements

August 6, 2019Brian PateBlog

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...

Jul

The FDA’s Role in Medical Device Cybersecurity

July 17, 2019Amy SellersNews

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,...

Jul

FDA Cybersecurity Committee Meeting

July 2, 2019Brian PateNews

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...

Jun

FDA Forum for Interoperability Feedback

June 27, 2019Brian PateNews

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...

Jun

Insulin Cybersecurity Safety Notice

June 27, 2019Brian PateNews

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.

May

FDA Pre-Cert Test Plan Recruiting

May 22, 2019Brian PateNews

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...

May

FDA Final Guidance Q-Submission Program

May 8, 2019Alan KusinitzBlog

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...

Apr

Quantitative Imaging

April 26, 2019Brian PateNews

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...

Apr

Classification of Accessories

April 11, 2019Alan KusinitzNews

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...

Apr

FDA publishes Unmet Medical Device Needs for Rare Diseases

April 6, 2019Jordan PateNews

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...

Apr

FDA Regulation of AI

April 4, 2019Alan KusinitzNews

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...

Mar

CBER Finalizes Standards Guidance

March 25, 2019Brian PateNews

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...

Mar

FDA Safety Communication on Cybersecurity Vulnerabilities

March 21, 2019Alan KusinitzNews

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,...

Mar

FDA Exempts Flow Cytometry from 510(k) requirements

March 14, 2019Brian PateNews

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...

Mar

FDA qualifies software module biomarker test

March 14, 2019Brian PateNews

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...

Mar

FDA Medical Device Development Tool (MDDT) Qualification

March 14, 2019Brian PateNews

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...

Mar

FDA Safety Communication on Software Update for Cardioverter Defibrillator failure

March 6, 2019Jordan PateNews

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 –...

Feb

Inclusion of URL in Electronic Labeling

February 27, 2019Brian PateNews

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...

Feb

Non-binding Feedback from FDA

February 21, 2019Alan KusinitzNews

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...

Feb

Refuse to Accept 510(k)

February 21, 2019Alan KusinitzNews

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...

Feb

FDA recognizes Defect Taxonomy Consensus Standard

February 20, 2019Brian PateNews

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...

Feb

FDA Least Burdensome Final Guidance

February 5, 2019Brian PateNews

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

Feb

Learning from FDA Safety Communications

February 2, 2019Brian PateBlog, Prem

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,...

Feb

VFA – LIFEPAK 15 Device locks up

February 1, 2019Jordan PateNews

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...

Jan

FDA Digital Health Precertification (Pre-Cert) update

January 19, 2019Alan KusinitzNews

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). ...

Jan

Verily Study Watch receives 510(k) clearance from FDA

January 18, 2019Brian PateBlog

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...

Jan

SoftwareCPR MobileApp – iPhone & Android

January 10, 2019Paul FeltenNews

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...

Jan

John F. Murray, Jr, joins SoftwareCPR as a partner

January 7, 2019Brian PateNews

(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...

Dec

Quick link to US FDA 21CFR820

December 24, 2018Brian PateBlog

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.

Dec

VFA – Medtronic issues voluntary field corrective action for ventilators

December 18, 2018Jordan PateNews

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...

Dec

New FDA Guidance – X-Ray

December 14, 2018Brian PateNews

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...

Dec

FDA Report on Non-Device Software Functions

December 14, 2018Alan KusinitzNews

FDA issued a report entitled “REPORT ON NON-DEVICE SOFTWARE FUNCTIONS: IMPACT TO HEALTH AND BEST PRACTICES – DECEMBER 2018.” This report contains findings on five software functions excluded from the device definition by the 21st Century Cures Act. The FDA found these software functions have more benefits than risks to patient safety and health. The...

Dec

Good Cyber Hygiene

December 14, 2018Brian PateBlog

Certainly everyone with any connection to information technology and networked devices is concerned with cybersecurity. However, often we just miss the basics – we do not practice good cyber hygiene. While not intended to be comprehensive or state-of-the-art, here are some security basics (or as some call it, “cyber hygiene”) that one should consider when developing...

Dec

FDA Draft Guidance Prescription POC

December 11, 2018Brian PateNews

FDA issued a draft guidance for prescription POC (Point-of-care) entitled “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.” This draft guidance document provides recommendations to industry about the types of information to include in their premarket submissions for blood glucose monitoring systems used for diabetes management in the health care prescription POC settings. This guidance...

Dec

FDA Draft Self-Monitoring OTC Glucose Test Systems

December 11, 2018Alan KusinitzNews

FDA issued a draft guidance entitled “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use“‘. This draft guidance document provides recommendations to industry about the studies and criteria to include in their premarket submissions for self-monitoring blood glucose test systems used for diabetes management in the home setting. This guidance (similar to the Prescription POC guidance)...

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Being Agile & Yet Compliant (Public)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

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Backlog management
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3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

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Next public offering: Dec 3, 4, & 5, 2024 – 12:00 pm to 5:00 pm CET

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future. Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply. Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

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Next public offering: TBD

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Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering: TBD

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