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Apr

2022 FDA Premarket Cybersecurity Guidance

April 20, 2022Brian PateNews

FDA has released a new draft of Premarket Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. Per the scope, this 2022 FDA Premarket Cybersecurity Guidance “is applicable to devices that contain software (including firmware) or programmable logic, as well as software as a medical device (SaMD). The guidance is not limited to devices...

Jan

Recall: Planning Software Defect Leads to Incorrect Amounts of Product Produced

January 26, 2022Allison PateNews

Company: Align Technology Inc Date of Enforcement Report: 01/26/2023 Class II PRODUCT Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001 Recall Number: Z-1017-2023 REASON 3D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may be produced (less or greater than...

Jan

Cybersecurity Alert – Infusion System vulnerability

January 12, 2022Jordan PateNews

FDA recently posted the following cybersecurity alert: On Tuesday, December 21, 2021, the Cybersecurity and Infrastructure Security Agency (CISA) published a vulnerability medical advisory ICSMA-21-355-01 on the Fresenius Kabi Agilia Connect Infusion System. Successful remote exploitation of these vulnerabilities could allow an attacker to gain access to sensitive information, modify settings, or perform arbitrary actions as an...

Dec

Transition from Research

December 29, 2021Brian PateBlog, Prem

When developing medical devices, a manufacturer may have difficulty knowing when (or what) the transition from research phase activities to design controls has begun. Often this is due to the nature of research itself - one is exploring a concept or design approach that may or may not pan out in the end. The US...

Dec

Cybersecurity Alert: Fresenius Agilia Connect

December 22, 2021Jordan PateNews

The US FDA announced on December 21, 2021, a cybersecurity alert for the Fresenius Kabi Agilia Connect Infusion System. The announcement referenced a Cybersecurity and Infrastructure Security Agency (CISA) publication of a vulnerability disclosure ICSMA-21-355-01 on the Fresenius Kabi Agilia Connect Infusion System. Successful remote exploitation of these vulnerabilities could allow an attacker to gain...

Nov

2021 FDA Draft Software Premarket Submission Guidance

November 3, 2021John MurrayBlog, News

Today, the U.S. Food and Drug Administration (FDA) issued the draft guidance: Content of Premarket Submissions for Device Software Functions. The draft guidance is intended to reflect FDA’s most current thinking on the recommended documentation sponsors should include in premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions, including both...

Oct

FY2022 SW Related Guidance

October 29, 2021John MurrayBlog, News

“From my 25 years at the agency, I completely understand that FDA CDRH guidance development, approval and publication is complex, time-consuming work. I often said it may be compared to threading 1000 needles simultaneously. It requires significant time and energy from many hard-working, dedicated professionals to even reach the first goal of published draft guidance....

Oct

Recall – CT Scanner does not proceed to next scan

October 27, 2021Jordan PateNews

Company: Canon Medical System, USA, INC. Date of Enforcement Report: 10/27/2021 Class II PRODUCT Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A Recall Number: Z-0142-2022 REASON A software problem has been identified which could result in the diagnostic imaging system not proceeding to the next actual scan even though automatic start of the next scan is...

Oct

MDIC Threat Modeling Playbook Update

October 27, 2021Jordan PateBlog

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...

Oct

FDA announces new guidance documents

October 27, 2021Jordan PateBlog, News

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...

Oct

Recall – MRI image slices missing

October 26, 2021Jordan PateNews

Company: GE Healthcare, LLC Date of Enforcement Report: 10/27/2021 Class II PRODUCT SIGNA Premier Recall Number: Z-0132-2022 SIGNA Architect Recall Number: Z-0133-2022 SIGNA Pioneer Recall Number: Z-0134-2022 Discovery MR750w 3.0T Recall Number: Z-0135-2022 Discovery MR750 3.0T Recall Number: Z-0136-2022 SIGNA Creator, SIGNA Explorer Recall Number: Z-0137-2022 SIGNA Voyager Recall Number: Z-0138-2022 SIGNA Artist Recall Number:...

Oct

Warning Letter – Lacks Verification Testing

October 21, 2021Jordan PateNews

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...

Sep

FDA Digital Transformation

September 23, 2021John MurrayBlog

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...

Aug

FDA AI/ML Workshop

August 28, 2021Brian PateNews

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

Aug

FY2022 User Fees

August 7, 2021Amy SellersNews

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:...

Jul

General Principles of Software Validation

July 25, 2021Brian PateBlog, News

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...

Jul

FDA releases guidance on implanted BCI devices

July 23, 2021Jordan PateNews

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...

Jun

FDA Recall: Injury Resulting from Exceeding Standard Presets

June 30, 2021Allison PateNews

Company: Olympus Corporation of the Americas Date of Enforcement Report: June 30, 2021 Class II PRODUCT Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterological surgery and gynecological...

Jun

FDA updates recognized consensus standards

June 22, 2021Jordan PateNews

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...

May

Science and Engineering Laboratories: Updates from FDA CDRH

May 19, 2021Jordan PateNews

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...

Apr

FDA Modifying Medical Device Classifications

April 19, 2021John MurrayBlog

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...

Apr

Ginny Kwan Gattinger joins SoftwareCPR as a Partner

April 7, 2021Amy SellersNews

(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...

Apr

Quality Injection Podcast – Brian Pate

April 3, 2021Amy SellersNews

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...

Feb

Safer Technologies Program for Medical Devices

February 1, 2021Amy SellersNews

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...

Dec

View draft revisions of FDA guidance?

December 4, 2020John MurrayBlog

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...

Nov

Draft guidance on EMC

November 17, 2020John MurrayBlog

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...

Nov

Distinguishing Significant and Nonsignificant Risk Devices

November 9, 2020Amy SellersBlog

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...

Nov

CDRH Proposed Guidance Updates

November 9, 2020John MurrayBlog

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...

Oct

Understanding OTS and SOUP

October 30, 2020Brian PateBlog

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...

Oct

New tools in the Catalog of Regulatory Science Tools

October 24, 2020Amy SellersNews

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...

Sep

Digital Health pre-cert program update

September 14, 2020John MurrayBlog

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...

Sep

Adverse Event Reporting for EUA Medical Devices

September 3, 2020Amy SellersNews

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...

Aug

An Intro to Medical Device Clinical Studies

August 22, 2020Amy SellersBlog

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...

Aug

Warning Letter – Even FB Claims Are Regulated

August 20, 2020Amy SellersNews

An important lesson from a Warning Letter citing FB Claims: In this Warning Letter to SilveryGuy, dated August 14, 2020, FDA – CDER informed the recipient that they had evaluated the company’s website and Facebook (FB) page. This demonstrates that even social media claims can establish the intended use of a product. Be careful what your...

Aug

Reviewing What We Know About LOC in Medical Devices

August 13, 2020Amy SellersBlog

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...

Aug

Warning Letter – Basic design controls violations

August 10, 2020Amy SellersNews

June 11, 2020 Interesting excerpts from a warning letter implicating 820.30: “[A]s part of the Convenience Kit manufacturing process, your firm opens and removes the original packaging of the finished device components, including sterile devices, before assembling, repacking, and relabeling the components together in a finished kit . . . handling such products in an...

Jul

New 510(k) Exemptions for Class II Devices

July 31, 2020Amy SellersNews

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...

Jul

FDA Final Guidance Requiring Electronic Submissions

July 30, 2020Amy SellersNews

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...

Jul

Understanding the Q-Sub Guidance

July 28, 2020Amy SellersBlog

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...

Jul

510(k) Approval for AI Imaging Analytics Device

July 28, 2020Amy SellersNews

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...

Jul

De Novo Classification Process in the Final Rule Stage

July 24, 2020Amy SellersNews, Prem

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...

Jul

Warning Letter – Cybersecurity of computerized systems

July 17, 2020Jordan PateNews

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...

Jul

Checklist to Qualify for a Real-Time PMA Supplement

July 17, 2020Amy SellersBlog, Prem

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...

Jul

Amy Sellers joins SoftwareCPR

July 13, 2020Brian PateNews

(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...

Jul

Software CAPA Can be Challenging

July 12, 2020Brian PateBlog, Prem

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...

Jul

FDA Calls for Comment on Non-Device Software Functions

July 9, 2020Amy SellersNews

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...

Jul

Current Status of FDA’s MDDT Program

July 8, 2020Amy SellersNews

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...

Apr

Non-Binding Feedback FDA Inspections

April 21, 2020Brian PateNews

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...

Apr

COVID-19 Public Health Emergency – Infusion Pumps

April 6, 2020Brian PateNews

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...

Mar

FDA Public Workshop – Artificial Intelligence in Radiological Imaging

March 27, 2020Brian PateNews

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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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!

Agile principles that align well with medical
Backlog management
Agile risk management
Incremental and iterative software development lifecycle management
Frequent release management
And more!

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

Lead Instructor: Mike Russell

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.

Instructor: Brian Pate

Next public offering: TBD

Call or email now to schedule a private, in-house class. The fall schedule is filling up!

Email training@softwarecpr.com to request a special pre-registration discount. Limited number of pre-registration coupons.

Registration Link:

TBD

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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