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fda
http://www.aami.org/news/2014/011514_FDA_Names_Issuing_Agencies_for_UDI.html
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Lisa Simone, a biomedical software engineer at FDA, published an article in the Biomedical Instrumentation & Technology Journal (Nov-Dec 2013) with information on an analysis of historical software related recalls using internal information at FDA as well as other sources. The article breaks down the recalls by year and product type. She investigated the years...
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http://mobihealthnews.com/27563/in-tense-hearing-congressman-declares-software-is-not-a-medical-device/
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FDA’s Device Center added a dedicated webpage on Cybersecurity for medical devices in its connected health section.
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Oct 22, 2013 press release from the office of Conressman Marsha Blackburn:”Congressman Marsha Blackburn (R-TN07) joined Representatives Gene Green (D-TX29), Dr. Phil Gingrey (R-GA11), Diana DeGette (D-CO01), Greg Walden (R-OR02), and G. K. Butterfield (D-NC01) today in introducing the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act to provide regulatory clarity regarding mobile...
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http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm
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http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm#ruleguidanc
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The FDA Safety and Innovation Act (FDASIA) workgroup completed its work and made its draft recommendations in September. The recommendations include: HIT should not be regulated except in cases where there is risk to the patient, a patient-safety risk framework should be used to allow application of regulatory oversight by risk, vendors should be required...
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FDA CDRH has increased its focus on networked medical devices, Health IT, wireless technologies, and telemedicine.  They have established a web page provide an overview which then has links to pages related to Mobile Medical Apps, Medical Device Data Systems, Home Health and Consumer Device, Health IT, and wireless medical devices.
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FDA has recognized a total of 25 standards on medical device interoperability and cybersecurity. These standards can be categorized into 3 groups: Risk management standards for a connected and networked environment (IEC 80001 series and ASTM F2761-09) Interoperability standards that establish nomenclature, frameworks, and medical device specific communications, including system and software lifecycle processes (ISO/IEEE...
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/docs/FDACybersecuritySafetyCommunication061413.pdf
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http://www.fda.gov/downloads/ForIndustry/FDAeSubmitter/UCM319824.pdf
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/Docs/scpred/standardsnavigator/GAO_FDA_security_report.pdf
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FDA issued a list of modifications to its standards recognitions. The link provided is the webpage where FDA posts each modification list.
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FDA released a new guidance dated July 3, 2012 entitled ” Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions. This guidance discusses types of Computer Aided Detection devices (CADe) and appropriate clinical data to include in 510(k)s and...
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Recipient:  Shamrock Medical Solutions Group LLC . Product:  Pharmeceuticals Date: 6/15/2012 Investigators from the Food and Drug Administration (FDA) identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug products to be adulterated within the meaning of...
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Recipient:  American Optisurgical Inc. Product:  TX1 Tissue Removal System Date: 6/14/2012 This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act [21 U.S.C. § 351(h)], in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity...
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http://www.fda.gov/iceci/inspections/fieldmanagementdirectives/ucm061430.htm
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Recipient: BTS S.p.A. Product: FreeEMG and PocketEMG Date: 5/10/2012 This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the...
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While FDA has oversight over Medical devices for vetinary use they are not treated like devices for human use. Generally a quality system although recommended is not required and unless the device emits radiation registration and listing is not required. Below is an excerpt from the FDA website: How FDA Regulates Veterinary Devices The Federal...
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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109203.pdf
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/docs/FDA-mobile-apps-draft-guidancePresentation.pdf
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/docs/FDA-StandaloneClinicalDecisionSupportSystemPresentation091211.pdf
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http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/ucm202511.htm
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For devices where the medical device manufacturer intends to maintain remote access capability for service and updates, controls are needed to ensure this access does not compromise the security or operation of the device. There is one FDA recognized standard that addresses this for clinical laboratory devices, but many of the provisions could be instructive...
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/docs/JMurray-FDApresentation-SoftwareRAPSIndianapolisOctober2011.pdf
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/docs/scpred/SafetyAssuranceCaseUpdate0911.pdf
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FDA issued an analysis of Premarket Review Times under the 510(k) Program. In two samples of submissions it analyzed software deficiencies in the submissions were noted in 14-20% of the submissions analyzed. The deficiencies included no software documenation provided, missing software description, missing trace matrix, missing list of anomalies, and/or missing validation. In addition form...
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/docs/QSR21CFR820BasicIntroductionKTrautman0511.pdf
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FDA has created a webpage dedicated to regulation of Medical Device Data Systems. Note that the deadline for registration and listing (including for healthcare institutions that would be considered MDDS manufacturers) is May 18, 2011, and the deadline for reporting adverse events through MedWatch is April 18, 2012.
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FDA issued a new list of recognized standards. This includes withdrawal of recognition of the previous version and recognition of: “12-218 NEMA PS 3.1–3.18 Withdrawn and replaced with newer version (2009) Digital Imaging and Communications in Medicine (DICOM) Set.”
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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.”
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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...
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/docs/MammographyGuidanceAddendum111610-UCM185904.pdf
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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.
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http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHTransparency/ucm228613.htm
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http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/forms/ucm081667.pdf
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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...
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/docs/FDAInfusionPumpDraftGuidance-042310-UCM209337.pdf
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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...
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/docs/FDATraining-Module7IEC62304-BECSconferencePresentation-JMurray110409.pdf
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/docs/FDA-MDDSpresentation4BECSConference-JMurray110409.pdf
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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...
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http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm187084.htm#7
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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
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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.
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/docs/JMurray-SoftwareDeviceClassification-AAMIStandardsConference031809.pdf
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This topic contains a number of FDA guidances and SoftwareCPR training aides related to preparation of software information in premarket submissions for FDA including 510(k)s, PMAs, and IDEs.
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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...
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http://www.fda.gov/cdrh/devadvice/314.html
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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.
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http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/ucm124082.htm
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http://www.softwarecpr.com/Docs/JohnMurraySlides-IEC62304-091508.pdf
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http://edocket.access.gpo.gov/2008/pdf/E8-17739.pdf
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/docs/JMurrayFDAsoftwarecompliancesciencepresentationversion2.0-02-20-2008.pdf
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