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Aug

FDA Connected Health Initiative

August 15, 2013Alan KusinitzNews

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.

Aug

FDA CDRH Final Guidance for Wireless Technology.

August 14, 2013Alan KusinitzNews

/docs/FDA-WirelessMedicalDeviceGuidance091413.pdf

Aug

FDA Radio Frequency Wireless Technology Gudance

August 14, 2013Alan KusinitzNews

/docs/FDARadioFrequencyWirelessTechnologyGuidance.pdf

Aug

FDA Recognizes 25 Networking & Cybersecurity Standards

August 6, 2013Alan KusinitzNews

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...

Jun

FDA Draft Cybersecurity Premarket Guidance.

June 14, 2013Alan KusinitzNews

/docs/CybersecurityFDADraftGuidance061413.pdf

Jun

FDA Cybersecurity Safety Communication.

June 13, 2013Alan KusinitzNews

/docs/FDACybersecuritySafetyCommunication061413.pdf

Apr

FDA releases Mobile App

April 24, 2013Alan KusinitzNews

http://1.usa.gov/I40tfj

Apr

Whole Slide Imaging – Class III?

April 24, 2013Alan KusinitzNews

http://capatholo.gy/1d2dXH6

Feb

FDA Distinguishing Recalls from Enhancements Draft

February 22, 2013Alan KusinitzNews

http://1.usa.gov/1igjXM2

Jan

FDA Final eCopy Guidance

January 3, 2013Alan KusinitzNews

/Docs/FDAeCopyFinalGuidance123112.pdf

Jan

FDA eCopies eSubmitter Quick Reference Guide

January 3, 2013Alan KusinitzNews

http://www.fda.gov/downloads/ForIndustry/FDAeSubmitter/UCM319824.pdf

Jan

FDA Revised 510(k) Refuse to Accept Policy

January 3, 2013Alan KusinitzNews

/Docs/FDARefuse2AcceptPolicy4510ks123112.pdf

Jan

FDA Revised PMA Filing Acceptance Guidance

January 3, 2013Alan KusinitzNews

/Docs/FDA-PMAFilingAcceptanceGuidance123112.pdf

Dec

FDA draft Electronic Source Data Guidance

December 2, 2012Alan KusinitzNews

http://1.usa.gov/18xZlGr

Oct

FDA Medical Device Free Online Training Modules

October 25, 2012Alan KusinitzNews

http://www.fda.gov/training/cdrhlearn/ucm162015.htm

Oct

FDA issues draft revised PMA Clock Guidance

October 18, 2012Alan KusinitzNews

http://1.usa.gov/18aG1Uw

Oct

FDA Revises 510(k) Clock Guidance

October 18, 2012Alan KusinitzNews

http://1.usa.gov/I40H6a

Oct

FDA Device Center draft Submission e-copy guidance

October 17, 2012Alan KusinitzNews

http://1.usa.gov/1hLDNAY

Oct

GAO report on FDA review ofmedical device security

October 12, 2012Alan KusinitzNews

/Docs/scpred/standardsnavigator/GAO_FDA_security_report.pdf

Oct

FDA Mobile Medical Apps Web page

October 1, 2012Alan KusinitzNews

http://bit.ly/2vTj0YB

Sep

Changes in FDA Registration and Listing FAQ

September 11, 2012Alan KusinitzNews

http://1.usa.gov/I3PR05

Aug

FDA Standards Recognition Modification Aug 2012

August 20, 2012Alan KusinitzNews

FDA issued a list of modifications to its standards recognitions. The link provided is the webpage where FDA posts each modification list.

Jul

FDA Clinical Data for Imaging Diagnosis submission

July 11, 2012Alan KusinitzNews

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...

Jun

Warning Letter – Shamrock Medical Solutions Group LLC

June 15, 2012Jordan PateNews

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...

Jun

Warning Letter – American Optisurgical Inc.

June 14, 2012Jordan PateNews

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...

May

FDA Inspection Issue Terminology

May 31, 2012Alan KusinitzNews

http://www.fda.gov/iceci/inspections/fieldmanagementdirectives/ucm061430.htm

May

Warning Letter – BTS S.p.A. FreeEMG and PocketEMG

May 10, 2012Jordan PateNews

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...

May

Paper copies of Electronic labeling

May 8, 2012Alan KusinitzNews

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

May

Veterinary products

May 8, 2012Alan KusinitzNews

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...

Apr

FDA Final 513(g) Guidance Requests for Information

April 12, 2012Alan KusinitzNews

/Docs/FDA-513gFinalGuidance040612.pdf

Mar

FDA Clinical Decision Support SW Presentation

March 16, 2012Alan KusinitzNews

/docs/FDA-StandaloneClinicalDecisionSupportSystemPresentation091211.pdf

Mar

FDA Mobile Medical Apps Presentation

March 16, 2012Alan KusinitzNews

/docs/FDA-mobile-apps-draft-guidancePresentation.pdf

Feb

FDA Infusion Pump Software Safety Research

February 13, 2012Alan KusinitzNews

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

Feb

Manufacturer remote access to medical device

February 2, 2012Alan KusinitzNews

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...

Oct

FDA RAPS Software Presentaton Oct 2011.

October 28, 2011Alan KusinitzNews

/docs/JMurray-FDApresentation-SoftwareRAPSIndianapolisOctober2011.pdf

Oct

FDA Pacemaker Pulse Generator Draft Guidance

October 19, 2011Alan KusinitzNews

http://1.usa.gov/I40OP0

Sep

Safety Assurance Case Update

September 23, 2011Alan KusinitzNews

/docs/scpred/SafetyAssuranceCaseUpdate0911.pdf

Jul

FDA Mobile Medical Apps Draft Guidance

July 20, 2011Alan KusinitzNews

http://1.usa.gov/o2ToMo

Jul

FDA 510(k) Software Deficiencies

July 20, 2011Alan KusinitzNews

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...

Jun

FDA Draft Guidance Low Glucose Suspend Systems

June 21, 2011Alan KusinitzNews

/docs/FDA-LGS-IDE-PMA-guidance062211.pdf

Jun

FDA Electronic Copies of Submissions Instructions

June 8, 2011Alan KusinitzNews

http://1.usa.gov/1fH22Mn

Jun

FDA 2010 Medical Device Warning Letter Summary

June 3, 2011Alan KusinitzNews

/docs/FDA2010MedicalDeviceQSData.pdf

Jun

IVD Software for Investigational Use Only-Draft

June 1, 2011Alan KusinitzNews

http://1.usa.gov/j87y0Q

May

FDA Basic Intro Quality System Regulation

May 17, 2011Alan KusinitzNews

/docs/QSR21CFR820BasicIntroductionKTrautman0511.pdf

Apr

FDA MDDS Webpage and Dates

April 20, 2011Alan KusinitzNews

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.

Mar

FDA recognizes revised DICOM standard

March 15, 2011Alan KusinitzNews

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.”

Mar

FDA intending to release a Mobile Apps Guidance

March 14, 2011Alan KusinitzNews

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.”

Nov

Reprint of JMDR FDA Software Regulation article

November 26, 2010Alan KusinitzNews

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...

Nov

FDA Digital Mammography Inspection Addendum

November 17, 2010Alan KusinitzNews

/docs/MammographyGuidanceAddendum111610-UCM185904.pdf

Nov

FDA Full Field Digital Mammography Guidance

November 10, 2010Alan KusinitzNews

/docs/FFD-MammographyGuidance110510-ucm107553.pdf

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IEC 62304 and other emerging standards for Medical Device and HealthIT Software

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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
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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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