FACTA Farmaceutici S.p.A Product: drug manufacturing facility Date:1/13/2017 1. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)). For multiple sterile drug product lots, your original data showed failing results, but data you reported showed passing results....Read More

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 DevicesRead More

FDA issued a safety notice: Cybersecurity Vulnerabilities Identified in St. Jude Medical’s Implantable Cardiac Devices and Merlin@home Transmitter.Read More

What the 21st Century Cures Act Means for Software Manufacturers The 21st Century Cures Act (“Cures Act”), was signed into law by the President on December 13, 2016 (Public Law No. 114-255). This article focuses on section 3060 of the new law; namely “Clarifying Medical Software Regulation.” Other sections of the act address medical devices...Read More

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...Read More

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.Read More

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...Read More

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/Read More

/docs/scpred/FDAFInalGuidanceBenefitRiskinDeviceAvailability1216.pdfRead More

http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm528236.htmRead More

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm517526.htmRead More

/docs/FDA-MRIguidance1998.pdfRead More

/docs/FDA-MRIguidance1998.pdfRead More

http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm523316.htmRead More

/docs/FDAMDRGuidance110916ucm359566.pdfRead More

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/Read More

http://www.fda.gov/MedicalDevices/ResourcesforYou/HealthCareProviders/ucm525916.htmRead More

http://www.fda.gov/Training/CDRHLearn/default.htmRead More

http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM519346.pdfRead More

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM512648.pdfRead More

http://www.fda.gov/MedicalDevices/DigitalHealth/ucm512245.htmRead More

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm504091.pdfRead More

The US FDA issued a draft guidance entitled: “Use of Electronic Health Record Data in Clinical Investigations”. This draft addresses a variety of issues including EHRs certified by ONC, data modifications, audit trials, informed consent, and Privacy and Security. The full draft guidance can be found at the following link: FDA_Use_of_EHR_Data_in_Clinical_InvestigationsRead More

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM268141.pdfRead More

/docs/FDADrug-25591_Data-Integrity.pdfRead More

Recipient:  Polydrug Laboratories Pvt. Ltd. Corporate Office Product:  Pharmaceuticals Date: 4/11/2016 Failure of computerized systems to have sufficient controls to prevent unauthorized access or changes to data. Your firm’s computer system for entering test results and storing certificates of analysis (CoA), which document whether a drug meets specifications, does not have sufficient controls to prevent...Read More

http://www.gpo.gov/fdsys/pkg/FR-2016-04-04/html/2016-07467.htmRead More

/docs/scpred/FDA-2015WL-483DataPresentationV_1312016.pdfRead More

http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm484914.pdfRead More

/docs/FDAhighestprioritydevices4humanfactorsreview0216.pdfRead More

/docs/FDA-HFE-UE-FinalGuidance0216.pdfRead More

FDA held a two day public cybersecurity workshop Jan 20-21,2016.   See the output, including links to the webcasts, from the workshop sessions.Read More

FDA held a public workshop, “Collaborative Approaches for Medical Device and Healthcare Cybersecurity,” October 21-22, 2014, in partnership with the Department of Homeland Security. The program book issued by FDA after the workshop was held is at the link provided. It contains information on the sessions, objectives, and speaker biographies. Sherman Eagles of SoftwareCPR® was...Read More

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm467223.htmRead More

http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm313794.pdfRead More

A new International Medical Device Regulators Forum (IMDRF) document was finalized.  It is Software as a Medical Device (SaMD): Application of Quality Management System.  The objective of the document is to provide guidance on the application of existing standardized and generally accepted QMS practices to SaMD. View the document at this link:  imdrf-tech-151002-samd-qmsRead More

http://twitter.com/BPateCPRRead More

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/UCM396595.pdfRead More

http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm457581.htmRead More

https://www.federalregister.gov/articles/2015/10/16/2015-25597/2015-edition-health-information-technology-certification-criteria-2015-edition-base-electronicRead More

FDA maintains a webpage for its educational modules referred to as “CDRH Learn.”  Specialty Technical Topics provides a list with a section for IT and Software that includes three modules on Digital Health, Cybersecurity information in premarket submissions, and CDRH regulated software.Read More

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM459917.pdfRead More

http://www.gpo.gov/fdsys/pkg/FR-2015-08-18/html/2015-20309.htmRead More

/docs/FDApremarketclassificationcodexemptionsAug2015.pdfRead More

Interesting write up: “How Medical Tech Gave a Patient a Massive Overdose”.  The article can be found at https://www.healthleadersmedia.com/innovation/how-medical-tech-gave-patient-massive-overdoseRead More

FDA issued a safety communication to health care facilities using the Hospira Symbiq Infusion System regarding cybersecurity vulnerabilities. FDA is advising facilities to seek alternative infusion systems. In the interim, it is recommended the systems be disconnected from networks and maintain the drug libraries by updating manually along with other recommendations. An article regarding the...Read More

Company: New Star Lasers, Inc. Date of Enforcement Report: June 27, 2015 Class II PRODUCT StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, and General Surgery. Recall Number:...Read More

AAMI published an article entitled: “Best Practices in Applying Medical Device Risk Management Terminology” in its Spring 2015 Horizons publication. Alan Kusinitz, Founder of SoftwareCPR, co-authored this article and a reprint is provided with the permission of AAMI at the link provided. This is for your personal reference not for wider distribution due to the...Read More

FDA issued a revision to its “Mobile Medical Applications” Guidance Feb 9, 2015. The revision was to make this guidance consistent with the final “Medical Image Storage Devices, and Medical Image Communications Devices” guidance. Specific changes are FDA’s exercising of enforcement discretion to exempt MDDS and some Mobile Medical Apps from compliance the FDA regualtion....Read More

This draft was replaced by a final guidance in August 2016. It is provided here for historical comparison only. FDA issued a draft “General Wellness: Policy for Low Risk Devices” guidance on January 20, 2015. This draft policy continues to redefine the borderline for FDA regulation/non-regulation of Health IT along with their MDDS and MMApps...Read More