Tag

cdrh
FDA issued a draft guidance “Content of Premarket Submissions forManagement of Cybersecurity in Medical Devices” dated 10/17/18. This document contains a some terms(e.g. Cybersecurity Bill of Materal) and concepts (e.g.,Tier 1 and Tier 2 risks) that it is important for Manufacturers to understand and address in premarket submissions. It also includes labeling recommenations for cybersecurity...
Read More
FDA announces a new pilot program to simplify certain 510(k)s. For more information on eligibility click the link and scroll to near the bottom of the page.  
Read More
FDA has posted their FY 2019 Proposed Guidance Development list with priorities. A link is provided below but here is the “A” list items: Final Guidance Topics Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions Unique Device Identification: Policy Regarding Compliance Dates for Class...
Read More
For more information on eligibility click the link. You can also download the current working model.
Read More
Information on the FDA CDRH Patient Engagement Advisory Committee, including how to nominate candidates.
Read More
For a quick and easy way to find US regulations, including those related to FDA, click the link provided.  
Read More
To search FDA MDRs, click the link provided.  
Read More
FDA issued its list of planned Medical Device Guidance development for 2018. This list has 2 parts: priority development referred to as the A-List and other development referred to as B-list.. Note that FDA does not commit to accomplishing all items on either list; it is just stating its current intention. The A-List includes a...
Read More
The US Law PLAW-114Publ255 referred to as the 21st Century Cures Act published in Dec 2016 is at the link provided. There are many important elements of this law for Drugs, Devices, and Biologics. 21st Century Cures Act
Read More
The FDA webpage with a summary of how medical device recalls are handled and how FDA may notify the public is at the link provided. This includes examples of types of recall actions. We post software-related recalls on this website and SoftwareCPR can provide expert assistance in compliance with 21 CFR Part 806 Corrections and...
Read More
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm467223.htm
Read More
https://www.federalregister.gov/articles/2015/10/16/2015-25597/2015-edition-health-information-technology-certification-criteria-2015-edition-base-electronic
Read More
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM346553.pdf
Read More
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM419468.pdf
Read More
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm#ruleguidanc
Read More
http://www.fda.gov/iceci/inspections/fieldmanagementdirectives/ucm061430.htm
Read More
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109203.pdf
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
/docs/FDA-mobile-apps-draft-guidancePresentation.pdf
Read More
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/ucm202511.htm
Read More
/docs/JMurray-FDApresentation-SoftwareRAPSIndianapolisOctober2011.pdf
Read More
/docs/scpred/SafetyAssuranceCaseUpdate0911.pdf
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
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
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHTransparency/ucm228613.htm
Read 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/FDATraining-Module7IEC62304-BECSconferencePresentation-JMurray110409.pdf
Read More
/docs/FDA-MDDSpresentation4BECSConference-JMurray110409.pdf
Read 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
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
Read More
/docs/JMurray-SoftwareDeviceClassification-AAMIStandardsConference031809.pdf
Read More
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/ucm124082.htm
Read More
http://edocket.access.gpo.gov/2008/pdf/E8-17739.pdf
Read More
/docs/JMurrayFDAsoftwarecompliancesciencepresentationversion2.0-02-20-2008.pdf
Read More
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089402.htm
Read More
http://www.softwarecpr.com/Docs/Jmurray-AAMI-Webinar-December-4-2007-A.pdf
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
http://www.fda.gov/cdrh/mdufma/guidance/agenda/fy08.html#2
Read More
/docs/JMurrayPresentation-softwarecompliancescienceMarch2007.pdf
Read More
/docs/FDAPortableInvasiveGlucoseMonitoring-DraftGuidance102406.pdf
Read More
http://www.fda.gov/ForIndustry/FDAeSubmitter/default.htm
Read More
http://www.fda.gov/cdrh/osel/programareas/software.html
Read More
The final Device Center Inspection Compliance Policy Guide (provided at the link above and in the Library on this site) Part VI, Page 11, lists the following as points of contact related to software: “i. Questions regarding compliance of product software, stand alone software, process equipment software or the Year: 2000 Problem: Stewart Crumpler Office...
Read More
http://www.fda.gov/cdrh/comp/guidance/fod456.pdf
Read More
Expand your access! Subscribe today!

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.