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

/docs/FDARadiationBiodosimetryDevicesDraft.pdfRead More

/docs/FDADraft510kTransferGuidance122214.pdfRead More

/docs/FDAinfusionpumplifecycleguidance-ucm209337.pdfRead More

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM346553.pdfRead More

Sherman Eagles of SoftwareCPR® provides the following summary of some key points from FDA’s webinar on their premarket cybersecurity guidance on October 29. In the webinar FDA noted that the Instructions for Use should include what cybersecurity controls are needed in the use environment, but stated that it is not sufficient for a device to...Read More

The FDA held a two day public workshop on Collaborative Approaches for Medical Device and Healthcare Cybersecurity on October 21-22. Documentation on the workshop including the video recording of the workshop can be found at: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm412979.htm.Read More

/docs/scpred/SoftwareCPRenhanced-V-Diagram1014.pngRead More

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM419468.pdfRead More

FDA CDRH maintains a webpage for De Novo Summaries: Evaluation of Automatic Class III Designation De Novo Summaries. This is for devices that are novel but low to moderate risk ((not ideal for 510(k)s and PMA would be overly burdensome). There are now two options for de novo classification. One is in response to an...Read More

http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/ucm370879.htmRead More

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM418205.pdfRead More

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM418469.pdfRead More

/docs/FDACybersecurityPremarketGuidance1014.pdfRead More

The link provided is to FDA’s relatively new webpage related to connected health, including cybersecurity, Health IT, Mobile Medical Apps (MMA), and wireless medical devices. The MMA page provides lists of examples of types of MMApps and how they are or are not regulated. https://www.fda.gov/medicaldevices/digitalhealth/Read More

http://www.fda.gov/MedicalDevices/ScienceandResearch/MedicalDeviceDevelopmentToolsMDDT/Read More

/docs/FDAHomeUseDesignConsiderationGuidance0814.pdfRead More

/docs/FDADraft510kexemptionsguidanceAug2014.pdfRead More

/docs/FDAFiscalYear2015userFeeRates.pdfRead More

/docs/FDAEvaluatingSubstantialEquivalenceGuidance0714.pdfRead More

Brian Pate of SoftwareCPR® writes: In May 2014, FDA offered further guidance to manufacturers regarding premarket submission information identifying cyber-security risks and hazards associated with their medical devices, and the responsibility for engineering appropriate risk controls to address patient safety and assure proper device performance. FDA encouraged manufacturers to report any cyber-security incidents that may...Read More

http://blogs.fda.gov/fdavoice/index.php/2014/06/fda-encourages-medical-device-data-system-innovation/Read More

FDA issued a draft guidance: Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices. This draft exercises FDA enforcement discretion to essentially deregulate MDDS and Imaging Storage and Coummincation systems despite their classifcation rules. The guidance is at the link provided and proposes the new policy and provides specific wording changes...Read More

Just a reminder that FDA maintains a blog at the link provided. This generally contains short announcements with some explanation from FDA leads on policy and specific projects across all FDA divisions although one select specific divisions using the categories options. One recent posting was from Bakul Patel of the device center regarding the recent...Read More

http://open.fda.govRead More

In SoftwareCPR’s experience, translations and localization of user interfaces and labeling of medical devices for distribution in a variety of geographic regions can be challenging and can present safety issues if not properly handled.  Alan Kusinitz of SoftwareCPR® co-authored an article on localization risk management with one of the large companies that provides such services...Read More

http://tinyurl.com/k29hoseRead More

It appears that the Center directed ORA to inspect Class I firms and provided each regional/district offices with a list of 50 firms to choose from. These inspectionsappear to be in part a validation exercise of the risk based approach to only inspecting higher risk firms. We are assuming it is for the remainder of...Read More

http://www.fda.gov/downloads/Training/CDRHLearn/UCM311629.pdfRead More

http://tinyurl.com/ok6scdbRead More

http://tinyurl.com/n8f2bpeRead More

/docs/FDAPre-SubPresentation-UCM387291.pdfRead More

/docs/FDApremarketReviewCommunicationsGuidance040414.pdfRead More

The Director, Office of Policy and Planning, of the Office of the National Coordinator for Health Information Technology provided an overview presentation on ONC’s perspective on the FDASIA draft report. The slides are at the following link: FDASIA-HITDraftReportOverview0414 As with all presentations SoftwareCPR reminds readers to refer to the actual source documentation, in this case the...Read More

The FDA released its anticpated draft report on regulation of Health IT. This report includes a risk-based regulatory framework for health information technology (health IT) that is a step towards clarifying what software will be actively regulated by FDA. The report was developed by the U.S. Food and Drug Administration in coordination with the Health...Read More

In a new draft guidance (for electrosurgical devices; but in our opinion representative of information needed for other devices) FDA stated that cybersecurity information including but not limited to the following should be provided: Confidentiality assures that no unauthorized users have access to the information. Integrity is the assurance that the information is correct –...Read More

http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm383206.htm#s5Read More

The link provided is to a white paper prepared by Northwest Cadence regarding use of Microsoft Visual Studio to aid in compliance with FDA requirements. Food and Drug Administration (FDA) Compliance with Visual Studio 2010Read More

/docs/FDApresubmissionFeedbackGudiance.pdfRead More

http://www.aami.org/news/2014/020514_FDA_Overhaul_Inspection_Compliance_Activities.htmlRead More