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cdrh
US FDA has proposed a new rule to exempt Cytometry instruments used for counting or characterizing cells (a well-understood and mature technology), from premarket notification requirements.  Cytometry instruments used for sorting or collecting cells, and instruments that are used as an automated hematology analyzer, or that perform automated differential cell counts, will still require premarket...
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Medical Device Development Tool (MDDT) Qualification The US FDA has provided guidance on the methods and approaches to qualify a medical device development tool so that medical device manufacturers or sponsors can use them to support the development and evaluation of medical devices.  The manufacturer is expected to ensure the tool produces “scientifically-plausible measurements” and...
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For those currently or intending to distribute electronic labeling for their medical devices, be aware that in 2010 FDA issued a guidance entitled “Addition of URL to Electronic Product Labeling”.  This guidance contains a recommendation: “ …that manufacturers include their Uniform Resource Locator (URL) on their electronic product labels in addition to the requirements under...
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FDA issued a version of its “Refuse to Accept Policy for 510(k)s” dated 21-Feb-2019. This supersedes the prior 30-Jan-2018 version.  As FDA guidance goes, this a short period of time between updates.  It focuses on explaining the initial 15 day administrative completeness check, review initial questions, provision of a checklist for this administrative review which...
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FDA issued a draft guidance “Content of Premarket Submissions forManagement of Cybersecurity in Medical Devices”, dated 10/17/18. This document contains some terms (e.g. Cybersecurity Bill of Material) and concepts (e.g., Tier 1 and Tier 2 risks) that is important for manufacturers to understand and address in premarket submissions. It also includes labeling recommendations for cybersecurity...
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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.  
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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...
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For more information on eligibility click the link. You can also download the current working model.
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Information on the FDA CDRH Patient Engagement Advisory Committee, including how to nominate candidates.
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For a quick and easy way to find US regulations, including those related to FDA, click the link provided.  
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To search FDA MDRs, click the link provided.  
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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...
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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
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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...
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http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm467223.htm
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https://www.federalregister.gov/articles/2015/10/16/2015-25597/2015-edition-health-information-technology-certification-criteria-2015-edition-base-electronic
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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM346553.pdf
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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM419468.pdf
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http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm#ruleguidanc
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http://www.fda.gov/iceci/inspections/fieldmanagementdirectives/ucm061430.htm
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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109203.pdf
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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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/docs/FDA-mobile-apps-draft-guidancePresentation.pdf
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http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/ucm202511.htm
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/docs/JMurray-FDApresentation-SoftwareRAPSIndianapolisOctober2011.pdf
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/docs/scpred/SafetyAssuranceCaseUpdate0911.pdf
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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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http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHTransparency/ucm228613.htm
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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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