Guiding clients to effective and efficient compliance and regulatory approvals

COURSE DATES: June 4 – 6, 2019 TRAINING LOCATION: Boston, MA USA COST: 3 Full Days for $2,495.00 Get 24% off for 4 or more from same company registering with same payment! Seats are still available — don’t miss this fantastic opportunity to learn the elements of a 62304 compliant SDLC and integrate the expectations...
Read More
Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 5/15/2019 Class II PRODUCT Atellica IM 1300 Analyzer, Material Number 11066001; Recall Number: Z-1299-2019 Atellica IM 1600 Analyzer, Material Number 11066000; Recall Number: Z-1300-2019 Atellica Sample Handler Prime, Material Number 11069001; Recall Number: Z-1301-2019 REASON There were multiple issues identified in the system software which required...
Read More
Company: Medtronic Inc. Date of Enforcement Report: 5/15/2019 Class II: PRODUCT Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices. Recall Number: Z-1282-2019 REASON The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in the...
Read More
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...
Read More
A 2015 article providing a review of the factors that contribute to a potentially insecure environment, together with the identification of the vulnerabilities, and why these vulnerabilities persist and what the solution space should look like.
Read More
Company: Viewray, Inc. Date of Enforcement Report: 5/8/2019 Class II PRODUCT MRIdian Linac Radiation Therapy System, Model 20000. Recall Number: Z-1251-2019 REASON A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur. RECALLING FIRM/MANUFACTURER Viewray, Inc on 3/18/2019. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT...
Read More
Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 5/8/2019 Class II PRODUCT SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. Recall Number: Z-1245-2019 SOMATOM Edge Plus, Model Number 10267000 Recall Number: Z-1246-2019 SOMATOM Definition...
Read More
Company: Fenwal Inc. Date of Enforcement Report: 5/1/2019 Class II PRODUCT Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: 1. AT-1 sets and kits (9005104 AT-1 Autotransfusion set, 9108504 ATF 120 Fast Start Kit, and 9108494 ATF 40 Fast Start Kits); 2. AT-3 Autotransfusion sets and kits (Part 9005444 AT-3 set,...
Read More
Company: Ortho-Clinical Diagnostics Date of Enforcement Report: 5/1/2019 Class II PRODUCT VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides,...
Read More
Software Quality
Many years ago, Capers Jones, the software metrics guru, analyzed his database of thousands of software projects for the key factors affecting “real” software quality.  “Real” software quality relates to how the software actually performed and how robust in the field.   His list in priority order was: Programmer Application (domain) Experience Programmer Technical Experience Reuse...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. Recent standards and regulatory activity overview Medical device software Following the failure of the DIS of 62304 to be approved, the IEC 62304 working group requested input from the ISO and IEC member countries. There was not a consensus...
Read More
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,...
Read More
exempt Cytometry premarket notification
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...
Read More
Today FDA qualified the Osirix CDE Software Module biomarker test for use by medical device developers to identify and enroll patients into Traumatic Brain Injury (TBI) studies.  This is the third qualification of a medical device development tool (MDDT) by the FDA, and the first of a software module biomarker test tool type. A biomarker...
Read More
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...
Read More
Our March 2019 Newsletter has been published.  Learn of significant regulatory and standards related activity associated medical device software, medical mobile apps, and HealthIT software.  Also you can find dates for upcoming training opportunities.
Read More
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 –...
Read More
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...
Read More
What does one need to know about IEC 62304? In our 3-day 62304 Training course, we flow through the software development lifecycle drawing attention to requirements of the standard as well as related standards and always current FDA expectations from our experience.  The topics we plan to cover in our 2019 course are below. Topics: Regulatory...
Read More
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...
Read More
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...
Read More

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.