MASSDEVICE reported that “At a Food & Drug Administration town hall meeting held March 10 in Irving, Texas, Center for Devices and Radiological Health director Dr. Jeffrey Shuren disclosed … that the agency plans to issue guidance on mobile medical applications later this year.”Read More

The pdf at the link provided is a reprint of an article in the November 2010 issue of the Jounal of Medical Device Regulation entitled “US Medical Device Software Regulation”. This article was authored by Sherman Eagles, and Alan Kusinitz, Partners at SoftwareCPR.  The article provides an overview of FDA regulations related software distributed in...Read More

/docs/MammographyGuidanceAddendum111610-UCM185904.pdfRead More

/docs/FFD-MammographyGuidance110510-ucm107553.pdfRead More

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.Read More

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

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

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...Read More

/docs/FDA-HHE-Form0710-UCM126211.pdfRead More

/docs/FDAInfusionPumpLetter042310.pdfRead More

/docs/FDAInfusionPumpDraftGuidance-042310-UCM209337.pdfRead More

http://1.usa.gov/1iglotURead More

http://bit.ly/17yzzs2Read More

/docs/FDA-IntroToRegulatedSoftwareJMurray0310.pdfRead More

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...Read More

/Docs/FDA-BECS510kworkshopTranscript110909.pdfRead More

/docs/FDACybersecurityReminder110409.pdfRead More

/docs/FDATraining-Module7IEC62304-BECSconferencePresentation-JMurray110409.pdfRead More

/docs/FDA-MDDSpresentation4BECSConference-JMurray110409.pdfRead More

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...Read More

/docs/FDAdraftImagingCADesubmissionguidance102109.pdfRead More

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

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 20993-0002Read More

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.Read More

/docs/JMurray-SoftwareDeviceClassification-AAMIStandardsConference031809.pdfRead More

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  Read More

http://www.fda.gov/cdrh/devadvice/314.htmlRead More

http://www.fda.gov/cdrh/manual/pmamanul.pdfRead More

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...Read More

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.Read More

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/ucm124082.htmRead More

/docs/FDA-DraftProcessValidationGiuidance111808.pdfRead More

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

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

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

/docs/FDAUltrasoundSubmissionGuidance0908.pdfRead More

http://www.fda.gov/cdrh/comp/guidance/1140.pdfRead More

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

/docs/FDASubmissionsPresentation2005Rosecrans.pdfRead More

/docs/JMurrayFDAsoftwarecompliancesciencepresentationversion2.0-02-20-2008.pdfRead More

/Docs/FDA-CTInspectionalGuidance.pdfRead More

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089402.htmRead More

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

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...Read More

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...Read More

/docs/ORA-BIMOCPG7348-808-att_a.PDFRead More

https://www.softwarecpr.com/docs/CBERbecsvalidationguidanceDraft1007.pdfRead More

/docs/FDAUserFeesFiscal2008.pdfRead More

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...Read More

/Docs/FDA-IOMerecordssection2007.pdfRead More