regulatory Archives

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regulatory

Jan

Canadian Regulatory Framework Presentation

January 24, 2024Allison PateNews

Learn about the Canadian regulatory framework from SoftwareCPR® partner, Ginny Kwan Gattinger, who will give a presentation at the RAPS Global Regulatory Strategy Conference in Baltimore, MD on March 7, 2024, at 10:30 am EST. The conference is being held at the Hilton Baltimore near the BWI Airport. Ginny will co-present with our affiliate, Karen...

May

Webcast – Ontario and Vancouver RAPS

May 9, 2023Ginny GattingerNews

New to medical device software? Our partners Mike Russell and Ginny Kwan Gattinger will be presenting a Regulatory Affairs Professional Society (RAPS) webinar on Wednesday, May 17, 2023 at 1:00 pm EDT to discus the unique and amplified challenges with software development for SiMD and SaMD. They will discuss approaches for addressing the challenges and...

Oct

FDA Guidance on AI Requests

October 26, 2022Amy SellersNews

FDA releases Guidance on AI requests. To aid manufacturers and reviewers, this guidance emphasizes the “Least Burdensome Provisions” when responding to deficiencies in a regulatory submission. Download the final guidance: 2022-guidance-responding-deficencies-least-burdensome As stated by FDA, this guidance is “intended to help FDA staff develop, and industry respond to, a request for additional information needed to make a...

Apr

Taiwan FDA online Pre-market Application Platform

April 25, 2022Jordan PateNews

May

IFU “How To” Website

May 24, 2021Jordan PateNews

New to medical devices and need an orientation of the creation of instructions for use (IFU)? A good place to start may be a website prepared by Ferry Vermeulen, a director at INSTRKTIV. In further preparation for the Medical Device Regulation (MDR) enforcement in the EU, Ferry prepared a guide on how to create IFU for...

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...

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Draft guidance on EMC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...

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

Brazil moves to notification pathway for Class II devices

September 28, 2020Amy SellersNews

Brazil eliminates a premarket approval pathway, instead allowing for premarket notification. Previously, Brazil has had a “Cadastro” pathway to register Class II medical devices and IVDs. This pathway required more extensive documentation (like a technical dossier) for Class II and higher-risk Class I devices. However, on September 18, 2020, the Brazilian regulatory agency, National Health...

Sep

Medical Device Reforms in Australia

September 3, 2020Amy SellersNews

The Therapeutic Goods Administration (TGA), the regulatory body for therapeutic goods in Australia, had previously announced that various medical device reforms would be enacted from 2019 through 2024. The transition period was (and still is) set to end on October 31, 2024. However, this summer, TGA announced a delay in the commencement of the medical device...

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

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

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

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...

Feb

Clinical Exemptions for SaMD in China

February 26, 2020Jordan PateNews

In the China National Medical Products Administration (NMPA) Classification Catalog, SaMD can be Class II and III; it cannot be Class I. This means that not all SaMD will require clinical trials and may fit into clinical exemptions for SaMD in China. According to Medical Device Clinical Trial Exemption Catalog issued on September 30, 2018, seven...

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!

Aug

German BfArM Identifies VxWorks Critical Vulnerabilities

August 27, 2019Brian PateNews

Today, the German Federal Institute for Drugs and Medical Devices (BfArM) identified critical vulnerabilities in the Wind River VxWorks real-time operating system. Affected versions of VxWorks are: VxWorks 6.5 to 6.9 (End-of-Life) VxWorks 7 (SR540 and SR610) VxWorks 653 MCE 3.x (may be affected) They pointed out that VxWorks is used in many medical devices....

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 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 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

New Approach for Health Canada

January 24, 2019Amy SellersBlog

Health Canada has recently provided a new approach for device approval as outlined in their “Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality.” Canada classifies medical devices based on their potential risk, with Class I devices being lowest-risk and Class IV devices presenting the highest risk. The collaborative new approach aims to...

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...

Dec

EU Medical Device Harmonized Standards Links – Updated

December 20, 2018Sherman EaglesNews

Here are some quick links to websites that list the harmonised standards for the different directives.

Dec

Health Canada Cybersecurity Draft Guidance

December 14, 2018Alan KusinitzNews

Health Canada issued a draft guidance document titled, “Pre-market Requirements for Medical Device Cybersecurity.” Section 1.1 states: “Health Canada considers the inclusion of cybersecurity measures an important consideration in issuing medical device licenses. Therefore, this guidance document provides medical device manufacturers advice on the practices, responses and mitigation measures which can improve the cybersecurity of...

Nov

FDA CDRH Patient Advisory Committee Public Meeting

November 15, 2018Alan KusinitzNews

The Food and Drug Administration (FDA) is announcing a forthcoming public advisory committee meeting of the Patient Engagement Advisory Committee (the Committee). The general function of the Committee is to provide advice to the Commissioner, or designee, on complex issues relating to medical devices, the regulation of devices, and their use by patients. The meeting...

Oct

TGA Releases Classification Tool

October 10, 2018Amy SellersNews

The Australian medical device regulatory division TGA has release a new online tool to assist manufacturers with classifying their products. The SME Assist tool “is a dedicated service that TGA offers to help small to medium enterprises (SMEs), researchers, start-ups and those unfamiliar with regulation to understand their regulatory and legislative obligations.”

Oct

Current EC Directives on medical devices

October 4, 2018Jordan PateNews

Medical devices within the EU are currently regulated by three Directives: Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990) Council Directive 93/42/EEC on Medical Devices (MDD) (1993) Council Directive 98/79/EC on in vitro Diagnostic Medical Devices (IVDMD) (1998)

Jun

FDA Q-Submission Program Draft Guidance

June 7, 2018Jordan PateNews

FDA issued the draft guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” June 7, 2018. Note that there are a variety of types of Q-submissions and they do not need to be tied to a specific planned 510(k) or other premarket submission. Also note that they are not meant to...

Nov

Free Android App with FDA regulations

November 17, 2017Amy SellersNews

Want a free Android app as a quick reference to the regulations? Paul Felten of SoftwareCPR has developed a new app just for that purpose. You can find it by searching for “SoftwareCPR” in the Google Play store! Google Play – SoftwareCPR app

Oct

EU Proposed Cybersecurity Regulation

October 18, 2017Sherman EaglesNews

The EU has proposed a new regulation on cybersecurity. While this regulation is not specific to the health sector, health is mentioned as critical infrastructure in the proposal. The proposal would provide a revised mandate, objectives, and tasks for ENISA, the “EU Cybersecurity Agency.” The new tasks include: Facilitating the establishment and take-up of European...

Apr

EU Medical Device Regulation

April 5, 2017Alan KusinitzNews

The EU MDR of April, 5, 2017 is at the link below. Clause (19) states: “It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, qualifies as a...

Feb

China FDA (CFDA) English Website

February 10, 2017Alan KusinitzNews

View the english version of the China FDA (CFDA) website. Formerly the State FDA (SFDA), the CFDA is promoting use of 62304 for medical device software and essentially ISO/IEC 14764 for IT maintenance. It is also actively expanding its requirements related to cybersecurity of networked devices.

Aug

EU Network Security Directive 2016

August 7, 2016Sherman EaglesNews

The European Union has published a Directive concerning measures for a high common level of security of network and information systems across the Union. The directive does not impose any new requirements on manufacturers that are not operators of essential services or digital services. Instead, it relies on existing rules on product liability. EU Network...

Jun

EU MDR Trilogue Agreement

June 23, 2016Sherman EaglesNews

This agreement includes a number of clarifications to the EU Medical Device Regulations. The Environment, Public Health and Food Safety (ENVI) Committee of the European Parliament and Council’s Committee of Permanent Representatives (COREPER) voted to endorse the trilogue agreement on June 15. The text of the draft MDR is at the link provided. The text...

Jun

EU IVD Trilogue Agreement

June 23, 2016Alan KusinitzNews

See the item on the MDR Trilogue Agreement for further explanation. The text for the IVD draft is a the link provided here: EU IVDR.

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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 offerings:

Americas: 11-13 February 2025
EU/Eastern Europe/Middle East/Africa/Atlantic/eastern South America: 18-20 February 2025
Southern Central Northeastern Pacific: 24-26 February 2025

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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