Alan Kusinitz, Author at SoftwareCPR

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Alan Kusinitz

Jun

Facebook Harvesting PPI from Hospital Websites

June 16, 2022Alan KusinitzNews

The Markup, a nonprofit newsroom that investigates how powerful institutions are using technology to change our society, reports that Facebook has been collecting patients’ sensitive health information—including details about their medical conditions, prescriptions, and doctor’s appointments—and sending it to Facebook. They found that 33 of Newsweek’s top 100 hospitals in America contained a tracker, called the...

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...

Jul

Health Canada releases new cybersecurity guidance

July 10, 2019Alan KusinitzBlog

Health Canada released the full guidance document, Pre-market Requirements for Medical Device Cybersecurity. It can be viewed at: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/cybersecurity.htm It includes requirements such as: “Risk management is required for all medical devices throughout their life-cycle. Manufacturers should incorporate cybersecurity into the risk management process for every device that consists of or contains software. Manufacturers are...

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

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

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,...

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...

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). ...

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...

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

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)...

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...

Nov

62304 Second Edition Questionnaire

November 13, 2018Alan KusinitzBlog, StdNav

This content is only available to Standards Navigator subscribers. See our Subscribe page for information on subscriptions. Questionnaire asking the national bodies to choose which approach to risk management should be used in the second edition of IEC 62304. 62304 Edition 2 Questionnaire

Nov

62304 Second Edition Presentation

November 13, 2018Alan KusinitzBlog, Prem

This content is only available to our Premium subscribers. A presentation on IEC 62304 Second Edition may be found at the following link: IEC 62304 2nd Edition Presentation

Nov

FDA CDRH Special 510(k) Program Pilot Webinar

November 8, 2018Alan KusinitzNews

For more information on this webinar click the link provided.

Nov

Nov 6, 2018 High Integrity Software Conference

November 6, 2018Alan KusinitzNews

Bristol, UK. Now in its fifth year, the mission of the High Integrity Software conference is to share challenges, best practice and experience between software engineering practitioners. The conference features talks from industrial and academic specialists which disseminate experience and knowledge of important techniques and methods that are applicable across industry sectors. For more information...

Oct

FDA Webinar Consensus Use of Standards

October 26, 2018Alan KusinitzNews

Oct

FDA Draft Cybersecurity Premarket Guidance

October 17, 2018Alan KusinitzNews

FDA issued a draft guidance “Content of Premarket Submissions forManagement of Cybersecurity in Medical Devices”, dated 10/17/18. This document contains some terms (e.g. Cybersecurity Bill of Material) and concepts (e.g., Tier 1 and Tier 2 risks) that is important for manufacturers to understand and address in premarket submissions. It also includes labeling recommendations for cybersecurity...

Oct

FDA Final Guidance – Use of Standards Guidance

October 15, 2018Alan KusinitzNews

This final guidance, “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices,” replaces the 2013 draft guidance. This guidance focuses on clarifying and formalizing existing FDA practice including the requirement to submit FDA’s standards form for each standard used as well as discusses the use of obsolete standards. Originally standards were a...

Oct

SoftwareCPR October 2018 Newsletter

October 13, 2018Alan KusinitzNews

This SoftwareCPR.com newsletter in pdf form lists items added to the web site from early-June 2018 through mid-October 2018. It serves as an easy reference to find new or updated items that may be of interest to you. Please search the library to see all items posted as the newsletter only lists new or updated...

Oct

Manufacturers Assistance and Technical Training Branch (MATTB)

October 2, 2018Alan KusinitzNews

Email: Industry.Biologics@fda.hhs.gov Phone: 240-402-8020 or 1-800-835-4709 After hours (after 4:30 pm EST weekdays, all day on weekends, and federal holidays) FDA Emergency Call Center, Phone: 866-300-4374 or 301-796-8240 What The MATTB Does CBER’s Manufacturers Assistance and Technical Training Branch (MATTB) responds to public inquiries for information (by phone and email) from the biologics industry. MATTB strives to provide...

Oct

FDA CDRH Special 510(k) Pilot Program

October 2, 2018Alan KusinitzNews

Quality in 510(k) “Quik” Review Program Pilot The Quality in 510(k) (“Quik”) Review Program provides an alternate method to submit a premarket notification (510(k)) to the FDA using the eSubmitter software to format the submission. The FDA has identified a list of product codes that are eligible for this pilot. These device types are moderate risk and are considered...

Oct

FDA CDRH Updates SW Precert Pilot

October 1, 2018Alan KusinitzNews

For more information on eligibility click the link. You can also download the current working model.

Oct

FDA Biologics Assistance Branch (MATTB)

October 1, 2018Alan KusinitzNews

FDA Center for Biologics provides manufacturers with technical assistance. For email and phone contact information, and other information about this service, click the link.

Oct

FDA Reflects on National Cybersecurity Month

October 1, 2018Alan KusinitzNews

October is National Cybersecurity Month; for more information from FDA click the link.

Oct

Oct 1-4, 2018 RAPS Regulatory Convergence

October 1, 2018Alan KusinitzNews

Vancouver, BC Canada . Focused on global regulatory affairs and harmonization. For more information click the link provided. RAPS Regulatory Convergence

Oct

FDA Device Center Patient Advisory Committee

October 1, 2018Alan KusinitzNews

Information on the FDA CDRH Patient Engagement Advisory Committee, including how to nominate candidates.

Sep

All Recall Excerpts from Jan 2015 – present

September 26, 2018Alan KusinitzBlog, Prem

This content is only available to Premium and higher subscribers. See our Subscribe page for information on subscriptions. It contains all software and computer related recall excerpts for the years listed. Some of the newest recalls on the site may not be included. This compilation is provided in reverse chronological order and is useful for quick review,...

Sep

Warning Letter Excerpts – Jan 2014 to Sep 2018

September 26, 2018Alan KusinitzBlog, Prem

This content is only available to Premium and higher subscribers. See our Subscribe page for information on subscriptions. The attached pdf file contains all software and computer related warning letter excerpts posted on this site for the years listed. Some of the newest warning letters on the site may not be included since we only update this...

Sep

Sep 24-26, 2018 The MedTech Conference

September 24, 2018Alan KusinitzNews

Philadelphia, PA: The MedTech Conference features senior level politicians and executives and a wide array of educational programming. For more information, click the link provided.

Aug

Warning Letter – Pharmaceutical Laboratories and Consultants Inc

August 29, 2018Alan KusinitzNews

Pharmaceutical Laboratories and Consultants, Inc. Product: testing laboratory Date:8/29/18 This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211. Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within...

Aug

FDA Raises User fees Oct 1, 2018

August 1, 2018Alan KusinitzNews

Also states the new annual registration fees. Keep in mind, businesses with gross revenue under USD $100 million qualify for the reduced small business fees listed.

Jun

FDA eSubmitter Download Webpage

June 29, 2018Alan KusinitzNews

For information on FDA eSubmitter downloading and installation see the link. Let’s save the trees folks…

Apr

Ron Baerg now a Partner at SoftwareCPR

April 14, 2018Alan KusinitzNews

Ron Baerg, of Seminole, FL USA, is now a partner at Crisis Prevention and Recovery LLC (DBA SoftwareCPR ®), a full service medical device compliance and premarket submissions consultancy. Ron has over twenty three years experience in medical device software development and management. His experience has been primarily focused on large, complex medical device systems...

Mar

Production and Process Validation

March 14, 2018Alan KusinitzBlog

This content is only available to Premium level and Standards Navigator subscribers. See our Subscribe page for information on subscriptions. SoftwareCPR has prepared a collection of production and process validation material suitable for training in Production and Quality Systems 820.70(i) Validation including Part 11. Portions could be made into handouts or provided electronically. Download the manual...

Mar

FDA Software Recall Summary – 2017

March 10, 2018Alan KusinitzNews

Based on our searches and posting of software related recalls there appears to be a significant decrease of recalls reported to FDA in 2017 compared to 2016. Yearly total software recalls to the best of our ability to identify were for the past year are listed below. For previous years, search our library or look...

Mar

IMDRF Safety/Performance of Medical Devices/IVDs

March 3, 2018Alan KusinitzNews

The International Medical Device Forum, which FDA participates in, released a draft for comment entitled, “Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices.“ This guidance document describes fundamental design and manufacturing requirements, referred to as “Essential Principles of Safety and Performance” that, when met, indicate a medical device is safe and...

Dec

FDA Voluntary Device Malfunction Summary Reporting

December 26, 2017Alan KusinitzNews

The U.S. Food and Drug Administration issued a Federal Register notice with a proposed program for Voluntary Malfunction Summary Reporting. When finalized, this program would allow manufacturers to report certain malfunction medical device reports (MDRs) in a summary format on a quarterly basis instead of individually within 30 days. The proposed Voluntary Malfunction Summary Reporting...

Dec

FDA Changes to Medical SW Policies Draft Guidance

December 11, 2017Alan KusinitzNews

On Dec. 8, 2017 FDA released a Draft guidance “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act”. This guidance dsicusses software functions in relation to the modified device definition in the 21st Century Cures Act and the criteria for interpreting if and how medical software will or...

Dec

FDA Clinical Decision Support SW Draft Guidance

December 11, 2017Alan KusinitzNews

On Dec. 8, 2017 FDA released a Draft guidance “Clinical and Patient Decision Support Software”. This guidance addresses software for decision support in two categories: one used by Healthcare Professionals, the other used personally by patients and non-health professionals. It provides FDA interpretation of which types of Decision Support Software do not meet the definition...

Dec

FDA New Digital Health Policy Statement

December 9, 2017Alan KusinitzNews

On December 7, 2017, FDA Commissioner Scott Gottlieb, M.D., released the statement, “Advancing new digital health policies to encourage innovation, bring efficiency and modernization to regulation.” This statement announces the release of several new draft and final guidances as part of the FDA’s Health Innovation Action Plan published previously. The new guidances are posted separately...

Dec

FDA Digital Health Innovation Action Plan

December 8, 2017Alan KusinitzNews

Earlier this year FDA released the DH Action Plan, initiating several new guidances, policy changes, and its pre-certification program. Note: Information on the pre-certification program progress during 2017 and release of new guidance (December 2017) is posted separately.

Dec

Medical Device Section 21st Century Cures Act

December 1, 2017Alan KusinitzNews

An excerpt of the Medical Device Innovations Section of the US Law PLAW-114Publ255 referred to as the “21st Century Cures Act” and published in December of 2016 is at the link provided. There are many important elements of this law, including how accessories are classified and what software functions are not outside the definition of...

Dec

FDA Digital Health Webpage

December 1, 2017Alan KusinitzNews

The FDA maintains a dedicated webpage to provide ongoing information on FDA’s digital health initiative.

Nov

SoftwareCPR Nov 2017 Newsletter

November 16, 2017Alan KusinitzNews

This SoftwareCPR.com newsletter in .pdf form lists items added to the web site from mid-August 2017 through mid-November 2017. It serves as an easy reference to find new or updated items that may be of interest to you. Please search the library to see all items posted as the newsletter only lists new or updated...

Oct

FDA MDDS – Still Confusing After All This Time

October 31, 2017Alan KusinitzBlog

FDA regulation of Medical Device Data Systems has changed significantly over the years. This, together with the blurred line between MDDS and general health information technology, interfaces between MDDS and regulated medical devices, the actual criteria for deciding if something is classified as a Medical Device Data System, and different regulatory requirements outside the US...

Oct

FDA Final Deciding if a new 510(k) is needed

October 25, 2017Alan KusinitzNews

Supersedes 1997 guidance. FDA issued a new Final guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device” dated Oct. 25, 2017. TThe full guidance is at the link provided. Note that FDA simultaneously released a Final guidance for when to submit a new 510(k) for software changes specifically. Deciding When...

Oct

FDA Breakthrough Devices Program Draft Guidance

October 25, 2017Alan KusinitzNews

FDA published a draft guidance “Breakthrough Devices Program Draft Guidance for Industry and Food and Drug Administration Staff” dated 10/25/17. The full guidance is at the link provided. This supersedes the Expedited Access Pathway (EAP) introduced in 2015 and the Priority Review Program. The Breakthrough Devices Program is a voluntary program for certain medical devices...

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Being Agile & Yet Compliant (Public)

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

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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)

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