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...Read More

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.Read More

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 DevicesRead More

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...Read More

The FDA issued a draft guidance “Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers”.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 AnswersRead More

Company: Morton Grove Pharmaceuticals, Inc. Date:1/17/2017 Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)). Data Integrity Remediation Your quality system does not adequately ensure the accuracy and integrity of data to...Read More

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 ActRead More

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