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Jan

FDA Device Recall Summary Page

January 4, 2017Alan KusinitzNews

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...

Jan

21st Century Cures Act – Medical Device Summary

January 4, 2017Alan KusinitzNews

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.

Jan

21st Century Cures Act – Standalone SW Summary

January 4, 2017Alan KusinitzNews

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...

Dec

FDA Postmarket Cybersecurity Blog

December 29, 2016Alan KusinitzNews

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/

Dec

FDA FINAL Guidance Benefit-Risk in Medical Devices

December 27, 2016Alan KusinitzNews

/docs/scpred/FDAFInalGuidanceBenefitRiskinDeviceAvailability1216.pdf

Dec

FDA Webinar Final MDR guidance

December 6, 2016Alan KusinitzNews

http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm528236.htm

Nov

FDA Marketing of Concussion Evaluation Software

November 30, 2016Alan KusinitzNews

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm517526.htm

Nov

FDA New 510(k) MRI Device Submission Guidance

November 18, 2016Alan KusinitzNews

/docs/FDA-MRIguidance1998.pdf

Nov

FDA New 510(k) MRI Device Submission Guidance.

November 18, 2016Alan KusinitzNews

/docs/FDA-MRIguidance1998.pdf

Nov

FDA InteroperabilityPublic Workshop Results

November 9, 2016Alan KusinitzNews

http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm523316.htm

Nov

FDA MDR Final Revised Guidance

November 9, 2016Alan KusinitzNews

/docs/FDAMDRGuidance110916ucm359566.pdf

Nov

FDA Unique Device Identification Webpage

November 1, 2016Alan KusinitzNews

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

Oct

FDA Multidata Discontinue Use Letter

October 21, 2016Alan KusinitzNews

http://www.fda.gov/MedicalDevices/ResourcesforYou/HealthCareProviders/ucm525916.htm

Sep

FDA posted several new online training modules

September 9, 2016Alan KusinitzNews

http://www.fda.gov/Training/CDRHLearn/default.htm

Sep

FDA Letter with extension of deadlines UDI

September 7, 2016Alan KusinitzNews

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

Jul

FDA Draft Unique Identifier Guidance

July 29, 2016Alan KusinitzNews

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

Jul

FDA Interoperabilty Initiative Webpage

July 21, 2016Alan KusinitzNews

http://www.fda.gov/MedicalDevices/DigitalHealth/ucm512245.htm

May

FDA Guidance IDE Device Medicare Coverage

May 18, 2016Alan KusinitzNews

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

May

FDA Use of EHR data in Clinical Investigations

May 18, 2016Alan KusinitzNews

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_Investigations

May

FDA Final Postmarket Surveillance Guidance

May 17, 2016Alan KusinitzNews

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

Apr

FDA Drug & Biologics Data Integrity Draft guidance

April 30, 2016Alan KusinitzNews

/docs/FDADrug-25591_Data-Integrity.pdf

Apr

Warning Letter – Polydrug Laboratories Pvt. Ltd. Corporate Office

April 11, 2016Jordan PateNews

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...

Apr

FDA Standards Recogniton List Update April 2016

April 5, 2016Alan KusinitzNews

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

Mar

FDA Inspection Observation Summary for 2015.

March 16, 2016Alan KusinitzNews

/docs/scpred/FDA-2015WL-483DataPresentationV_1312016.pdf

Feb

FDA Draft Display Devices for Diagnostic Radiology

February 10, 2016Alan KusinitzNews

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

Feb

FDA Draft PriorityDevices for Human Factors Review

February 4, 2016Alan KusinitzNews

/docs/FDAhighestprioritydevices4humanfactorsreview0216.pdf

Feb

FDA Human Factors/ Usability Engineering Guidance.

February 3, 2016Alan KusinitzNews

/docs/FDA-HFE-UE-FinalGuidance0216.pdf

Jan

FDA Cybersecurity Workshop Materials

January 25, 2016Alan KusinitzNews

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

Jan

FDA 2015 Cybersecurity Workshop Program Book

January 18, 2016Alan KusinitzNews

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...

Jan

FDA issues 2016 planned guidance list

January 9, 2016Alan KusinitzNews

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm467223.htm

Dec

FDA New eCOPY for Medical Device Submissions

December 5, 2015Alan KusinitzNews

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

Nov

IMDRF Standalone SW QMS Guidance

November 16, 2015Alan KusinitzNews

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-qms

Nov

Brian Pate’s Twitter Feed

November 9, 2015Alan KusinitzNews

http://twitter.com/BPateCPR

Nov

FDA Accredits UDI Agencies

November 9, 2015Alan KusinitzNews

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

Oct

FDA Physiological Closed Loop Workshop

October 19, 2015Alan KusinitzNews

http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm457581.htm

Oct

ONC 2015 IT Certification Criteria.

October 11, 2015Alan KusinitzNews

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

Sep

FDA CDRH Learn HealthIT and Cybersecurity Modules

September 20, 2015Alan KusinitzNews

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.

Sep

Toxic gene guidance software information

September 8, 2015Alan KusinitzNews

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

Aug

FDA Quarterly MDR Reporting Pilot Program

August 19, 2015Alan KusinitzNews

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

Aug

FDA Premarket Exemptions August 2015

August 14, 2015Alan KusinitzNews

/docs/FDApremarketclassificationcodexemptionsAug2015.pdf

Aug

Health IT Medication Overdose Article

August 14, 2015Alan KusinitzNews

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-overdose

Jul

FDA Cybersecurity Safety Communication – Hospira

July 31, 2015Alan KusinitzNews

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...

Jun

FDA Recall: Discrepancy in Energy Delivered vs Value Displayed

June 27, 2015Allison PateNews

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:...

Apr

Best Practices in Risk Management Terminology

April 13, 2015Alan KusinitzNews

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...

Feb

FDA Revised Mobile Medical App Guidance Feb 2015

February 9, 2015Alan KusinitzNews

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....

Jan

FDA General Wellness Product Policy Draft

January 20, 2015Alan KusinitzNews

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...

Dec

FDA Radiation BioDosimetry Device Draft

December 31, 2014Alan KusinitzNews

/docs/FDARadiationBiodosimetryDevicesDraft.pdf

Dec

FDA 510(k) Transfer Draft Guidance.

December 23, 2014Alan KusinitzNews

/docs/FDADraft510kTransferGuidance122214.pdf

Dec

FDA Final Infusion Pump Guidance

December 4, 2014Alan KusinitzNews

/docs/FDAinfusionpumplifecycleguidance-ucm209337.pdf

Nov

FDA Instrument with combined functions guidance.

November 12, 2014Alan KusinitzNews

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

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IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future. Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply. Special deep discount pricing available to FDA attendees and other regulators.

3-days with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering: June 24-26, 2025 (Virtual, Live)

For private, in-house courses, please contact us.

Email training@softwarecpr.com for more info.

Being Agile & Yet Compliant (Public)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

Agile principles that align well with medical
Backlog management
Agile risk management
Incremental and iterative software development lifecycle management
Frequent release management
And more!

3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

Lead Instructor: Mike Russell

Next public offerings:

See our post titled: 1st Quarter 2025 Agile Compliant Courses Scheduled

Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering: TBD

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