http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm#ruleguidancRead More

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...Read More

/docs/FDAMMAppFinalGuidance0913.pdfRead More

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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.Read More

/docs/FDA-WirelessMedicalDeviceGuidance091413.pdfRead More

/docs/FDARadioFrequencyWirelessTechnologyGuidance.pdfRead More

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...Read More

/docs/CybersecurityFDADraftGuidance061413.pdfRead More

/docs/FDACybersecuritySafetyCommunication061413.pdfRead More

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http://capatholo.gy/1d2dXH6Read More

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http://www.fda.gov/downloads/ForIndustry/FDAeSubmitter/UCM319824.pdfRead More

/Docs/FDARefuse2AcceptPolicy4510ks123112.pdfRead More

/Docs/FDA-PMAFilingAcceptanceGuidance123112.pdfRead More

/Docs/FDAeCopyFinalGuidance123112.pdfRead More

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http://www.fda.gov/training/cdrhlearn/ucm162015.htmRead More

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/Docs/scpred/standardsnavigator/GAO_FDA_security_report.pdfRead More

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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.Read More

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...Read More

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...Read More

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...Read More

http://www.fda.gov/iceci/inspections/fieldmanagementdirectives/ucm061430.htmRead More

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...Read More

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...Read More

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109203.pdfRead More

/Docs/FDA-513gFinalGuidance040612.pdfRead More

/docs/FDA-mobile-apps-draft-guidancePresentation.pdfRead More

/docs/FDA-StandaloneClinicalDecisionSupportSystemPresentation091211.pdfRead More

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/ucm202511.htmRead More

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...Read More

/docs/JMurray-FDApresentation-SoftwareRAPSIndianapolisOctober2011.pdfRead More

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/docs/scpred/SafetyAssuranceCaseUpdate0911.pdfRead More

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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...Read More

/docs/FDA-LGS-IDE-PMA-guidance062211.pdfRead More

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/docs/FDA2010MedicalDeviceQSData.pdfRead More

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/docs/QSR21CFR820BasicIntroductionKTrautman0511.pdfRead More

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.Read More

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.”Read More