By

Alan Kusinitz
Health Canada issued a draft guidance document titled, “Pre-market Requirements for Medical Device Cybersecurity.”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...
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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...
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FDA issued a draft guidance entitled “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use“‘. This draft guidance document provides recommendations to industry about the studies and criteria to include in their premarket submissions for self-monitoring blood glucose test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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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...
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Questionnaire asking the national bodies to choose which approach to risk management should be used in the second edition of IEC 62304: Standards Navigator 62304 Ed2 Questionnaire
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A presentation on IEC 62304 Second Edition may be found at the following link: Standards Navigator 62304 Ed2 Presentation
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For more information on this webinar click the link provided.
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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...
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FDA issued a draft guidance “Content of Premarket Submissions forManagement of Cybersecurity in Medical Devices” dated 10/17/18. This document contains a some terms(e.g. Cybersecurity Bill of Materal) and concepts (e.g.,Tier 1 and Tier 2 risks) that it is important for Manufacturers to understand and address in premarket submissions. It also includes labeling recommenations for cybersecurity...
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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...
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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...
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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...
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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...
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For more information on eligibility click the link. You can also download the current working model.
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Information on the FDA CDRH Patient Engagement Advisory Committee, including how to nominate candidates.
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October is National Cybersecurity Month; for more information from FDA click the link.
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Vancouver, BC Canada . Focused on global regulatory affairs and harmonization. For more information click the link provided. RAPS Regulatory Convergence
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FDA Center for Biologics provides manufacturers with technical assistance. For email and phone contact information, and other information about this service, click the link.
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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,...
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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...
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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.  
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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...
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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.
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For information on FDA eSubmitter downloading and installation see the link. Let’s save the trees folks…
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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.
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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...
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The FDA maintains a dedicated webpage to provide ongoing information on FDA’s digital health initiative.
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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...
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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...
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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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FDA issued a finaguidance entitled “Deciding When to Submit a510(k) for a Software Change to an Existing Device)” dated October 25, 2017. This guidance clarifies for industy how to determine what software changes to a 510(k) cleared device require a new 510(k). It seems to reflect what FDA has been applying in the past but...
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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...
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SoftwareCPR now has a validation blog at the link provided. The latest entry as of 18-Oct-2017 contains some Retrospective Validation Tips provided by SoftwareCPR founder Alan Kusinitz. Earlier entries relate to Part 11, Agile methods, and Health IT. ValidationCPR Blog
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I don’t even really like to use the word retrospective
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The U.S. Food and Drug Administration released guidance document, “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff,” dated September 29, 2017. The guidance lists and explains the process for requesting meetings with the FDA. It explains proper use of these meetings, including examples of appropriate...
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A blog post by Brian Pate of SoftwareCPR see the link provided and scroll down. HealthIT and Software as a Medical Device
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SoftwareCPR now has a validation blog at the link provided. ValidationCPR Blog
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"AAMI TIR69: Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systems" available for purchase
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Participation in the PMA CtQ pilot program is voluntary and the program aims to evaluate device design and manufacturing process quality information early on to assist FDA in its review of the PMA manufacturing section and post-approval inspections. This voluntary pilot program is part of the FDA’s ongoing Case for Quality effort to apply innovative...
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On August 29, 2017, the FDA issued “Firmware Update to Address Cybersecurity Vulnerabilities Identified in Abbott’s (formerly St. Jude Medical’s) Implantable Cardiac Pacemakers: FDA Safety Communication.” The full document is at the link provided. Firmware Update to Address Cybersecurity Vulnerabilities in Abbott Pacemakers
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The FDA published a list of standards added to their recognition list on August 21, 2017. IEC 82304-1 Edition 1.0 2016-10. Health software part 1: General requirements for product safety are included on this list in the Software/Informatics Section, along with a number of other standards related to device communication (including specifics of glucose meters...
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UL 2900-1 Ed.1 2017 Standard for Software Cybersecurity Network-Connectable Products, Part 1: General Requirements was recognized by FDA on August 21, 2017. See at: FDA Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 047.
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Here are some thoughts from a recent conversation between Sherman Eagles, Brian Pate, and Alan Kusinitz of SoftwareCPR®: Cybersecurity vulnerabilities can have unpredictable effects on safety.  Unpredictable effects … to those who have worked to reduce risks of software failures in medical device software, that phrase may be familiar.  That concept is explained in relation to...
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FDA issued a new draft guidance entitled”Draft Guidance for Industry; How To Prepare a Pre-Request for Designation”. This guidance is intended to describe informal interaction with FDA that might lead to a formal Designation request to determine wether a product will be regulator as a device or a drug and some combination thereof. The full...
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SoftwareCPR® – Human Factors and Usability Engineering Assessment Does the design of your device promote safe and effective use? Are you ready for an FDA regulatory submission requiring HFE/UE report? Do you maintain a usability engineering file for your products? Is it complete? Do you have a systematic process for identifying and analyzing use error?...
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FDA issues a new draft guidance in June 2017 titled “Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers”.  This guidance while scoped for clinical investigations has information that is probably useful and defensible for assessing or ensuring compliance with other types of systems subject...
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FDA CDRHLearn released a new tutorial entitled ‘Electronic Submission of 806 Reports of Corrections and Removals”. The full tutorial is at the link provided. FDA Tutorial E-submission of 806 reports
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Symantec Cybersecurity expert Axel Wirth provided an AAMI podcast presentation June 21, 2017 titled “Patch Management in Healthcare”.  The podcast is on the AAMI page at the link provided along with several other podcasts related to cybersecurity in the prior two episodes.
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http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm563249.htm
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http://blogs.fda.gov/fdavoice/index.php/2017/06/fostering-medical-innovation-a-plan-for-digital-health-devices/
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FDA, together with the National Science Foundation (NSF) and the Department of Homeland Security Science, and Technology, held a public workshop May 18-19, 2017. Results of this workshop, including webcasts of the sessions, are at the FDA website. Public Workshop – Cybersecurity of Medical Devices: A Regulatory Science Gap Analysis, May 18-19, 2017
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At the AAMI/FDA Software Regulatory Class being held this week, it was stated that the following are expected to be released this summer by FDA: – Revision to the premarket cybersecurity guidance – Final of the interoperability guidance
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This SoftwareCPR.com newsletter in pdf form lists items added to the web site from mid Late December 2016 through late April. 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...
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The FDA page on Medical Device Use of Symbols in Labeling is at the link provided. FDA currently allows use of symbols in place of text for medical devices and certain biologics provided the use is compliant with 21 CFR Parts 660, 801, and 809. FDA Use of Symbols in Medical Device Labeling
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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...
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FDA seeks manufacturers to provide onsite learning opportunities for FDA staff. In the areas of Digital Health/Software FDA is interested in 4 topics: Cybersecurity, Software Development, Total product life-cycle development processes and methodologies, and Software testing. The link provided is the main FDA webpage on this program and has a link to the full list...
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FDA issued a draft list of Class II Medical Devices exemptions from the 510(k) premarket notification requirements to comply with the 21st Century Cures Act. Note that 884.1630 is NOT exempt if it contains software for image analysis or smartphone use. Other software-related sections of note are 86.2570 and 882.1470.
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The presention material for the FDA Webinar – Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions Final Guidance – February 23, 2017 is at the link provided. FDA Presentation on Benefit-Risk IDE Devices
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http://www.congress.gov/bill/115th-congress/senate-bill/404/text
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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.
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http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm398226.htm
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FDA issued a Final guidance entitled: “Postmarket Management of Cybersecurity in Medical Devices”. FDA held a free webinar on this guidance on Jan. 12,2017. Information information and presentation materials are at the link provided. SoftwareCPR can provide expert cybersecurity consulting services for regulatory compliance andrisk analysis, technical threat and vulnerability assessment as well as for...
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The FDA issued a draft guidance “Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers”. The full draft is at the link provided. Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR checklist for "IEC 82304-1: Health software - Part 1: General requirements for product safety."  82304 SoftwareCPR Checklist SoftwareCPR can provide conformance assessments, training, or expert consultation for efficient use and implementation of 82304 for medical device software as well...
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SoftwareCPR has posted its new checklist for “IEC 82304-1: Health software – Part 1: General requirements for product safety” in our website library and on our checklists page. This is free for our paid subscribers. SoftwareCPR can provide conformance assessments, training, or expert consultation for efficient use and implementation of 82304 for medical device software...
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The US Law PLAW-114Publ255 referred to as the 21st Century Cures Act published in Dec 2016 is at the link provided. There are many important elements of this law for Drugs, Devices, and Biologics. 21st Century Cures Act
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The US FDA issued a FINAL guidance entitled: “Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions”. This guidance references software features in Appendix C the device description section. The full guidance is at the link provided. FDA FINAL Guidance Benefit-Risk IDE Devices
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Sandy Hedberg of SoftwareCPR prepared a summary of the impact of the December 13, 2016, U.S. law, the 21st Century Cures Act on Standalone Software. Section 3060 addresses standalone software and exempts some software from regulation as a medical device. Sandy’s summary is at the link provided: 21st Century Cures Act – Software CPR Analysis....
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FDA issued a safety notice: Cybersecurity Vulnerabilities Identified in St. Jude Medical’s Implantable Cardiac Devices and Merlin@home Transmitter.
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The FDA webpage with a summary of how medical device recalls are handled and how FDA may notify the public is at the link provided. This includes examples of types of recall actions. We post software-related recalls on this website and SoftwareCPR can provide expert assistance in compliance with 21 CFR Part 806 Corrections and...
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Hyman, Phelps & McNamara posted a great summary of the impact of the 21st Century Cures Act in regards to general provisions affecting medical device regulation. They also provide links to summaries of other provisions of the act for standalone software (also posted on softwarecpr.com), and drugs and biologics impact.
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The law firm of Hyman Phelps and McNamara posted their summary of the impact on this Dec 13, 2016 US Law the 21st Century Cures Act. at the link provided. Section 3060 addresses standalone software and exempts some software from regulation as a medical device. They also provide links to summaries of other provisions of...
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http://blogs.fda.gov/fdavoice/index.php/2016/12/managing-medical-device-cybersecurity-in-the-postmarket-at-the-crossroads-of-cyber-safety-and-advancing-technology/
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/docs/scpred/FDAFInalGuidanceBenefitRiskinDeviceAvailability1216.pdf
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http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm528236.htm
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http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm517526.htm
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http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm523316.htm
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http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/
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http://www.fda.gov/MedicalDevices/ResourcesforYou/HealthCareProviders/ucm525916.htm
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What standards are helpful when creating or updating your software development process? Can compliance with standards benefit a medical device or HealthIT company with regulatory approval and/or FDA inspections? These questions and more will be answered at the upcoming 62304 training and emerging standards impacting Medical Device software and Health IT training course sponsored by...
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AAMI TIR 57 on medical device cybersecurity risk management will be published in 2016.  Status: The TIR has been recognized by the FDA before it was even been made available for purchase by AAMI. The TIR is now available for purchase from AAMI.
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National Law Review discusses a case before the EU Court of Justice to decide if medical software that provides support to healthcare professionals in prescribing medicinal products should be considered a medical device. The manufacturer prefers it to be considered a medical device to avoid more onerous requirements if it is not treated that way.
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http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM519346.pdf
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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM524904.pdf
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The attached pdf file contains all Part 11 related warning letter excerpts included on this site as of the date above.  This file is updated periodically, but for the most recent warning letters between these updates, do text...
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