The Director, Office of Policy and Planning, of the Office of the National Coordinator for Health Information Technology provided an overview presentation on ONC’s perspective on the FDASIA draft report. The slides are at the following link: FDASIA-HITDraftReportOverview0414 As with all presentations SoftwareCPR reminds readers to refer to the actual source documentation, in this case the...Read More

The FDA released its anticpated draft report on regulation of Health IT. This report includes a risk-based regulatory framework for health information technology (health IT) that is a step towards clarifying what software will be actively regulated by FDA. The report was developed by the U.S. Food and Drug Administration in coordination with the Health...Read More

In a new draft guidance (for electrosurgical devices; but in our opinion representative of information needed for other devices) FDA stated that cybersecurity information including but not limited to the following should be provided: Confidentiality assures that no unauthorized users have access to the information. Integrity is the assurance that the information is correct –...Read More

http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm383206.htm#s5Read More

The link provided is to a white paper prepared by Northwest Cadence regarding use of Microsoft Visual Studio to aid in compliance with FDA requirements. Food and Drug Administration (FDA) Compliance with Visual Studio 2010Read More

/docs/FDApresubmissionFeedbackGudiance.pdfRead More

http://www.aami.org/news/2014/020514_FDA_Overhaul_Inspection_Compliance_Activities.htmlRead More

The link provided is to an article on Fuzz testing. This type of testing involves injecting bad data to challenge your applications and safeguards. This type of testing can be important to verify risk control measures and data integrity checks are verified. The name Fuzz testing is a fairly recent moniker for techniques that have...Read More

http://wallstcheatsheet.com/stocks/more-apple-iwatch-clues-fda-meeting-and-healthbook-app.htmlRead More

http://www.aami.org/news/2014/011514_FDA_Names_Issuing_Agencies_for_UDI.htmlRead More

/docs/FDAComputationalModelsDraftGuidance0114.pdfRead More

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...Read More

http://tinyurl.com/nl9v9gvRead More

http://mobihealthnews.com/27563/in-tense-hearing-congressman-declares-software-is-not-a-medical-device/Read More

http://1.usa.gov/18AANxZRead More

FDA’s Device Center added a dedicated webpage on Cybersecurity for medical devices in its connected health section.Read More

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...Read More

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htmRead More

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

/docs/FDA-eSourceDataGuidance.pdfRead More

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

http://1.usa.gov/I40tfjRead More

http://capatholo.gy/1d2dXH6Read More

http://1.usa.gov/1igjXM2Read More

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

/Docs/FDARefuse2AcceptPolicy4510ks123112.pdfRead More

/Docs/FDA-PMAFilingAcceptanceGuidance123112.pdfRead More

/Docs/FDAeCopyFinalGuidance123112.pdfRead More

http://1.usa.gov/18xZlGrRead More

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

http://1.usa.gov/18aG1UwRead More

http://1.usa.gov/I40H6aRead More

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

/Docs/scpred/standardsnavigator/GAO_FDA_security_report.pdfRead More

http://bit.ly/2vTj0YBRead More

http://1.usa.gov/I3PR05Read More

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