The recent FDA guidance, Content of Premarket Submissions for Device Software Functions (June 14, 2023), points out that software design is a prospective activity and should not be done in an ad-hoc or last-minute approach.Read More
#software #capa … Should a #medicaldevices manufacturer treat potential software design issues any different than any other product #quality issue?Read More
Company: Philips North America Llc Date of Enforcement Report: 06/29/2023 Class II PRODUCT DigitalDiagnost C90, Model No. 712034 and 712035 Recall Number: Z-2042-2023 REASON: There is a software login in issue that may prevent the user from logging in. RECALLING FIRM/MANUFACTURER: Philips North America Llc VOLUME OF PRODUCT IN COMMERCE: 58 DISTRIBUTION: Distribution in US:...Read More
Company: Appliedvr Date of Enforcement Report: 06/29/2023 Class II PRODUCT RelieVR REF: RVX-2002, Rx Only Recall Number: Z-2044-2023 REASON: There is the potential for the program software to malfunction which will not allow it to move forward to the next session. RECALLING FIRM/MANUFACTURER: Appliedvr VOLUME OF PRODUCT IN COMMERCE: 1 unit DISTRIBUTION: US: NY OUS:...Read More
FDA released a draft guidance document for patient matched guides for orthopedic implants. The guidance provides recommendations to manufacturers regarding the design-and-production process for these types of devices. Patient matched guides, as the name implies, are unique to the patient and are created to assist pre-surgical planning. The clinician is better able to visualize proper...Read More
The US regulations for design controls have requirements for design and development planning. In fact, a design and development plan is an indication that a manufacturer has “exited” research phase activities and entered the development phase, and thus, design controls should be in place. The regulation, 21 CFR 820.30(b), specifically states: Design and development planning....Read More
In March 2023, FDA released a draft guidance on Part 11 Application to Clinical Investigations. The specific introduction in the guidance stated: This document provides guidance to sponsors, clinical investigators, institutional review boards(IRBs), contract research organizations (CROs), and other interested parties on the use of electronic systems, electronic records, and electronic signatures in clinical investigations...Read More
Company: SenTec AG Date of Enforcement Report: 06/20/2023 Class II PRODUCT V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS). Recall Number: Z-1980-2023 REASON: The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode “production” and were not reset to “released” mode. RECALLING...Read More
Company: Illumina, Inc. Date of Enforcement Report: 06/16/2023 Class II PRODUCT NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software Recall Number: Z-1976-2023 REASON: Cybersecurity vulnerability concerning the software used for sequencing instruments. RECALLING FIRM/MANUFACTURER: Illumina, Inc. VOLUME OF PRODUCT IN COMMERCE: 1067 units DISTRIBUTION: Worldwide distribution – US Nationwide and the countries...Read More
Company: Datascope Corp. Date of Enforcement Report: 06/14/2023 Class III PRODUCT Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX Recall Number: Z-1907-2023 REASON: The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU. RECALLING FIRM/MANUFACTURER: Datascope...Read More
Company: Datascope Corp. Date of Enforcement Report: 6/14/2023 Class III PRODUCT: Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX Recall Number: Z-1907-2023 REASON: The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU. RECALLING FIRM/MANUFACTURER: Datascope...Read More
FDA releases Final Guidance on Content of Premarket Submissions for Device Software Functions. This final guidance provides requirements for the recommended documentation manufacturers should include in premarket submissions for the FDA’s evaluation of the safety and effectiveness of device software functions. The guidance replaces the FDA’s Guidance for the Guidance for the Content of Premarket...Read More
Tampa, FL, May 10, 2023. Crisis Prevention and Recovery, LLC, dba SoftwareCPR® announced today that Windi has joined SoftwareCPR® as a Partner. In her role, Windi will lead the expert regulatory and quality team, bringing a unique client-side perspective for both US, Canada, UK/EU, and Japan markets. Windi’s career path is one marked by a...Read More
Our partner Windi Hary and I annotated a recent FDA Warning Letter. There is much one can learn from Warning Letters and we highly encourage our clients to make review and analysis of warning letters a regular part of your quality program. Click here to download this teaching aid: Warning Letter – iRhythm Technologies, Inc...Read More
The FDA completed its review of an Automated Ejection Fraction SaMD De Novo leading to a new Class II code, ‘QVD.’ The FDA notice follows including the special controls. FDA Notice Re: DEN220063 Trade/Device Name: Caption Interpretation Automated Ejection Fraction Software Regulation Number: 21 CFR 892.2055 Regulation Name: Radiological machine learning-based quantitative imaging software with...Read More
Company: BioReference Health, LLC Date of Enforcement Report: 06/02/2023 Class II PRODUCT The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates...Read More
Company: Medtronic Navigation, Inc. Date of Enforcement Report: 06/02/2023 Class I PRODUCT StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems Recall Number: Z-1666-2023 REASON: In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor resection/shunt placement/deep brain stimulation, where distance...Read More
Company: Medtronic Navigation, Inc. Date of Enforcement Report: 06/02/2023 Class I PRODUCT StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems Recall Number: Z-1666-2023 REASON: In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor resection/shunt placement/deep brain stimulation, where distance...Read More
Company: BioReference Health, LLC Date of Enforcement Report: 06/02/2023 Class II PRODUCT The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates...Read More
Company: Medtronic Navigation, Inc. Date of Enforcement Report: 06/02/2023 Class I PRODUCT StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems Recall Number: Z-1630-2023 REASON: During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no longer synchronize with other...Read More
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...Read More
Company: Draeger Medical Systems, Inc. Date of Enforcement Report: 4/27/2023 Class II PRODUCT Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower Recall Number: Z-1471-2023 REASON: The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity...Read More
Company: Hamilton Medical AG Date of Enforcement Report: 4/25/2023 Class II PRODUCT HAMILTON-C6, REF: 160021 Recall Number: Z-1429-2023 REASON: Software error causes, safety ventilation malfunction, in which ventilation continues in the “safety ventilation” mode with audible/visible alarm – patient inputs are not monitored, if the following coincide 1) A mode change to an adaptive mode...Read More
