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Oct

FDA CDER Part 11 Assessment Initiative

October 14, 2010Alan KusinitzNews

At the October AAMI Software Validation Course the FDA instructor indicated that the device center is not participating in this and that the Drug center’s intent is to gather information on how companies handle electronic records and signatures and not to ramp up enforcement of Part 11.

Oct

FDA OSEL Public Domain Software

October 8, 2010Alan KusinitzNews

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHTransparency/ucm228613.htm

Aug

FDA Standards Use Form for 510(k)s

August 15, 2010Alan KusinitzNews

http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/forms/ucm081667.pdf

Aug

FDA SOPP 8116 Electronic Signatures

August 13, 2010Jordan PateNews

FDA Center for Biologics Evaluation and Research released SOPP 8116 “Using Electronic Signatures for Investigational and Marketing Regulatory Document Concurrence/Signoff” Version #4 Effective Date: August 10, 2010. This describes their approach to using electronic signatures for certain regulatory approvals (including correspondence and premarket submissions) and is based on applying each person’s network profile identification via...

Jul

FDA Health Hazard Evaluation Form

July 2, 2010Alan KusinitzNews

/docs/FDA-HHE-Form0710-UCM126211.pdf

Apr

FDA Draft Infusion Pump Guidance

April 23, 2010Alan KusinitzNews

/docs/FDAInfusionPumpDraftGuidance-042310-UCM209337.pdf

Apr

FDA Infusion Pump Safety Initiative Web page

April 23, 2010Alan KusinitzNews

http://1.usa.gov/1iglotU

Apr

FDA Letter to Infusion Pump Manufacturers

April 23, 2010Alan KusinitzNews

/docs/FDAInfusionPumpLetter042310.pdf

Apr

FDA Posts Online Software Training Video

April 22, 2010Alan KusinitzNews

http://bit.ly/17yzzs2

Mar

FDA Presentation Intro to Regulated Software

March 25, 2010Alan KusinitzNews

/docs/FDA-IntroToRegulatedSoftwareJMurray0310.pdf

Mar

FDA to Recognize IEC 60601-1 Third Edition.

March 18, 2010Alan KusinitzNews

CDRH is immediately recognizing IEC 60601-1, third edition. The announcement was made yesterday morning at the 20th annual AAMI/FDA international standards conference by Carol Herman, director of the standards management staff at CDRH. The center’s acceptance of the standard also includes “all collaterals and particulars,” said Herman. She anticipates CDRH will publish a Federal Register...

Mar

FDA CBER Workshop Transcipt BECS 510(k)s

March 6, 2010Alan KusinitzNews

/Docs/FDA-BECS510kworkshopTranscript110909.pdf

Nov

FDA issues Cybersecurity Reminder Memo

November 5, 2009Alan KusinitzNews

/docs/FDACybersecurityReminder110409.pdf

Nov

FDA Presentation on 62304

November 5, 2009Alan KusinitzNews

/docs/FDATraining-Module7IEC62304-BECSconferencePresentation-JMurray110409.pdf

Nov

FDA Presentation on Draft MDDS Rule

November 5, 2009Alan KusinitzNews

/docs/FDA-MDDSpresentation4BECSConference-JMurray110409.pdf

Nov

FDA perspective on virtual machines

November 4, 2009Alan KusinitzNews

Sandy Hedberg of SoftwareCPR reported that at the BECS conference Nov. 4-5, 2009 Brian Fitzgerald of FDA gave a presentation in which use of virtual machines was mentioned. Sandy’s synopsis is: Brian Fitzgerald of FDA discussed use of the emerging technology, of virtual machines. A virtual machine is a hardware emulation layer of an operating...

Oct

FDA issues draft imaging CADe detection guidance

October 22, 2009Alan KusinitzNews

/docs/FDAdraftImagingCADesubmissionguidance102109.pdf

Oct

FDA Cardiac Allograft Gene Profiling Test Systems

October 21, 2009Alan KusinitzNews

http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm187084.htm#7

Oct

New FDA Device Center address for submissions

October 1, 2009Alan KusinitzNews

CDRH moved to a new location. The address of the document mail center for submissions and related communications is now: U.S. Food and Drug Administration Center for Devices and Radiological Health Document Mail Center – WO66-G609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

Apr

Update on status of MDDS rule

April 7, 2009Alan KusinitzNews

At public conferences representatives of FDA have indicated that the draft Medical Device Data System Classification rule was returned from FDA legal review for clarification of how public comments were addressed. This will delay release of the final rule perhaps 3-6 months, but this is hard to estimate.

Mar

FDA Presentation on Classification of Software

March 20, 2009Alan KusinitzNews

/docs/JMurray-SoftwareDeviceClassification-AAMIStandardsConference031809.pdf

Dec

FDA Software Premarket Submissions

December 26, 2008Jordan PateNews

The key guidance document from FDA regarding the software documentation required in a premarket submissions for FDA including 510(k)s, PMAs, and IDEs is the “Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005

Dec

FDA Premarket Approval (PMA) Web Page

December 24, 2008Alan KusinitzNews

http://www.fda.gov/cdrh/manual/pmamanul.pdf

Dec

Checklists

December 24, 2008Alan KusinitzNews

This topic provides educational checklists related to several standards and regulations. SoftwareCPR checklists are available to paid subscribers of www.softwarecpr.com by using their login. These are only intended for use by those experienced in the related regulations and standards and are not intended to be used blindly as there may be significant interpretational ambiguities and...

Dec

FDA 510(k) webpage

December 24, 2008Alan KusinitzNews

http://www.fda.gov/cdrh/devadvice/314.html

Dec

Selected Presentations

December 23, 2008Alan KusinitzNews

This topic contains several of the slide sets for presentations posted on the website. These include ONLY SOME of the FDA staff presentations as well as SoftwareCPR presentations. Others are available in the library section of the website.

Dec

FDA Medical Device Reporting webpage

December 21, 2008Alan KusinitzNews

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/ucm124082.htm

Nov

FDA CDER Draft Process Validation Guidance Rev.

November 18, 2008Alan KusinitzNews

/docs/FDA-DraftProcessValidationGiuidance111808.pdf

Oct

FDA issues online video QSR training

October 7, 2008Alan KusinitzNews

http://www.fda.gov/cdrh/cdrhlearn/

Sep

FDA Human Factors Information webpage

September 18, 2008Alan KusinitzNews

http://www.fda.gov/cdrh/humanfactors/

Sep

FDA Software 62304 Slides – John Murray

September 15, 2008Alan KusinitzNews

https://www.softwarecpr.com/Docs/JohnMurraySlides-IEC62304-091508.pdf

Sep

FDA Ultrasound Submission Guidance and software

September 15, 2008Alan KusinitzNews

/docs/FDAUltrasoundSubmissionGuidance0908.pdf

Aug

FDA PMA Design Control Information Guidance

August 9, 2008Alan KusinitzNews

http://www.fda.gov/cdrh/comp/guidance/1140.pdf

Aug

FDA 2009 Submission User Fees

August 8, 2008Alan KusinitzNews

http://edocket.access.gpo.gov/2008/pdf/E8-17739.pdf

Aug

FDA CDRH Rosencrans Submissions Presentation

August 3, 2008Alan KusinitzNews

/docs/FDASubmissionsPresentation2005Rosecrans.pdf

Mar

FDA Software Presentation – Compliance Science

March 20, 2008Alan KusinitzNews

/docs/JMurrayFDAsoftwarecompliancesciencepresentationversion2.0-02-20-2008.pdf

Mar

FDA CDRH CT Radiation Devices inspection checklist

March 9, 2008Alan KusinitzNews

/Docs/FDA-CTInspectionalGuidance.pdf

Jan

FDA guidance for interactive premarket reviews

January 5, 2008Alan KusinitzNews

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089402.htm

Dec

FDA John Murray Software Training & Part 11 Update

December 9, 2007Alan KusinitzNews

https://www.softwarecpr.com/Docs/Jmurray-AAMI-Webinar-December-4-2007-A.pdf

Dec

FDA CDRH OSEL Software Analysis Tools

December 8, 2007Alan KusinitzNews

Brian Fitzgerald Deputy Division Director, Division of Electrical and Software Engineering, FDA CDRH, Office of Science & Engineering Laboratories, provided a list of software analysis tools FDA’s laboratory uses in evaluating medical device code. This was in response to a question posed at a recent AAMI Webinar that John Murray of FDA and Alan Kusinitz...

Dec

Medical Device Software Recalls Summary 2007

December 4, 2007Alan KusinitzNews

In an AAMI Webinar John Murray of FDA indicated that it appears that software issues comprise 16 percent of medical device recalls and there is some thought to developing some special procedures for handling these. SoftwareCPR has found approximately 75 recalls related to software as of the end of November 2007 for the year which...

Nov

FDA Computer System Inspection for BIMO-Part 11

November 22, 2007Alan KusinitzNews

/docs/ORA-BIMOCPG7348-808-att_a.PDF

Oct

CBER issues draft BECS Validation Guidance

October 28, 2007Alan KusinitzNews

https://www.softwarecpr.com/docs/CBERbecsvalidationguidanceDraft1007.pdf

Oct

FDA Premarket Submission Fees

October 26, 2007Alan KusinitzNews

/docs/FDAUserFeesFiscal2008.pdf

Oct

SoftwareCPR 21 CFR Part 11 Reference Manual$

October 24, 2007Alan KusinitzBlog, Prem

This content is only available to Premium and higher subscribers. See our Subscribe page for information on subscriptions. 21 CFR Part 11 is a topic of current focus for FDA and industry. This manual contains the most important FDA documents related to Part 11 as well as some key SoftwareCPR educational Aides as listed below: This manual...

Oct

FDA ORA IOM Electronic Records Guidance 2008

October 22, 2007Alan KusinitzNews

/Docs/FDA-IOMerecordssection2007.pdf

Oct

FDA Remote Medication System Guidance

October 20, 2007Alan KusinitzNews

http://1.usa.gov/MLAXIU

Oct

FDA new device guidance planned for 2008.

October 8, 2007Alan KusinitzNews

http://www.fda.gov/cdrh/mdufma/guidance/agenda/fy08.html#2

Oct

FDA Standards Recognition and USe Guidance

October 1, 2007Alan KusinitzNews

http://www.fda.gov/cdrh/osel/guidance/321.pdf

Sep

CBER-CDRH Draft Guidance IVDMIA systems

September 30, 2007Alan KusinitzNews

/docs/FDAOIVD-IVDMIAdraftguidance072507.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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