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cdrh

Nov

Understanding Risk with Medical Devices

November 17, 2022John MurrayBlog

On November 15, 2022, I had the pleasure to log in to a “live” FDA CDRH Industry Basics Seminar on Understanding Risk with Medical Devices. You can view the workshop at this link: https://fda.yorkcast.com/webcast/Play/4aecf454d2d54039a1d5a6a3001d78c31d I did enjoy the materials presented and I do think the presenters Joseph and Tonya did a great job. I would recommend...

Nov

CDRH Proposed Guidance Updates

November 9, 2020John MurrayBlog

FDA released their CDRH Proposed Guidance Updates that includes a significant amount of “software related” guidance in FY 2021. There are four separate guidance documents listed for publication in FY 2021. IMO that is a fairly large commitment from the agency and I will look forward to reading about the agency’s “current thinking” on these...

Aug

Reviewing What We Know About LOC in Medical Devices

August 13, 2020Amy SellersBlog

Remember the 2005 guidance document, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices? In 2020 that guidance is as relevant as ever, and it can be useful to review what we know about the FDA’s expectations regarding Level of Concern (LOC) in medical devices. LOC is important if for no...

Jul

510(k) Approval for AI Imaging Analytics Device

July 28, 2020Amy SellersNews

On July 16, 2020, FDA issued 510(k) Approval for AI Imaging Analytics Device HealthMammo, a device manufactured by Zebra Medical Vision Ltd. As reported in the New York Times, HealthMammo is an artificial intelligence (AI) product that analyzes mammograms for suspicious lesions. Radiologists can use the HealthMammo results to prioritize which mammogram images need attention...

Jul

Checklist to Qualify for a Real-Time PMA Supplement

July 17, 2020Amy SellersBlog, Prem

This content is only available to our Premium subscribers. See our Subscribe page for information on subscriptions. What is a Real-Time PMA Supplement? Section 737(4)(D) of the Federal Food, Drug, and Cosmetic Act defines a Real-Time PMA Supplement as: “a supplement to an approved premarket application or premarket report under section 515 that requests a...

Jul

Current Status of FDA’s MDDT Program

July 8, 2020Amy SellersNews

On June 24, 2020, there was an update to the current status of FDA’s MDDT program. CDRH announced a new tool had qualified as MDDT. This is only the sixth tool to qualify since the MDDT Guidance document was finalized in 2017. See the list of qualified tools here: https://www.fda.gov/medical-devices/science-and-research-medical-devices/medical-device-development-tools-mddt. What is the Medical...

Apr

Non-Binding Feedback FDA Inspections

April 21, 2020Brian PateNews

FDA released a new guidance document titled, “Nonbinding Feedback After Certain FDA Inspections of Device Establishments, Guidance for Industry and Food and Drug Administration Staff. This guidance was issued on April 22, 2020. The background on the guidance states, “Timely nonbinding feedback can help device firms determine whether proposed actions to address inspectional observations are...

Mar

FDA Exempts Flow Cytometry from 510(k) requirements

March 14, 2019Brian PateNews

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...

Mar

FDA Medical Device Development Tool (MDDT) Qualification

March 14, 2019Brian PateNews

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...

Feb

Inclusion of URL in Electronic Labeling

February 27, 2019Brian PateNews

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...

Feb

Refuse to Accept 510(k)

February 21, 2019Alan KusinitzNews

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...

Oct

FDA Draft Cybersecurity Premarket Guidance

October 17, 2018Alan KusinitzNews

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...

Oct

FDA CDRH Special 510(k) Pilot Program

October 15, 2018Jordan PateNews

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.

Oct

FDA CDRH 2019 New Guidance Plan

October 6, 2018Brian PateNews

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...

Oct

FDA CDRH Updates SW Precert Pilot

October 1, 2018Alan KusinitzNews

For more information on eligibility click the link. You can also download the current working model.

Oct

FDA Device Center Patient Advisory Committee

October 1, 2018Alan KusinitzNews

Information on the FDA CDRH Patient Engagement Advisory Committee, including how to nominate candidates.

Sep

US Code of Federal Regulations

September 12, 2018Jordan PateNews

For a quick and easy way to find US regulations, including those related to FDA, click the link provided.

Sep

FDA Medical Device Report Database

September 12, 2018Jordan PateNews

To search FDA MDRs, click the link provided.

Dec

FDA CDRH 2018 Proposed Guidance Development

December 14, 2017Jordan PateNews

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...

Jan

21st Century Cures Act

January 15, 2017Alan KusinitzNews

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

Jan

FDA Device Recall Summary Page

January 4, 2017Alan KusinitzNews

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...

Nov

FDA New 510(k) MRI Device Submission Guidance

November 18, 2016Alan KusinitzNews

/docs/FDA-MRIguidance1998.pdf

Nov

FDA New 510(k) MRI Device Submission Guidance.

November 18, 2016Alan KusinitzNews

/docs/FDA-MRIguidance1998.pdf

Sep

FDA posted several new online training modules

September 9, 2016Alan KusinitzNews

http://www.fda.gov/Training/CDRHLearn/default.htm

Feb

FDA Human Factors/ Usability Engineering Guidance.

February 3, 2016Alan KusinitzNews

/docs/FDA-HFE-UE-FinalGuidance0216.pdf

Jan

FDA issues 2016 planned guidance list

January 9, 2016Alan KusinitzNews

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm467223.htm

Oct

ONC 2015 IT Certification Criteria.

October 11, 2015Alan KusinitzNews

https://www.federalregister.gov/articles/2015/10/16/2015-25597/2015-edition-health-information-technology-certification-criteria-2015-edition-base-electronic

Dec

FDA 510(k) Transfer Draft Guidance.

December 23, 2014Alan KusinitzNews

/docs/FDADraft510kTransferGuidance122214.pdf

Nov

FDA Instrument with combined functions guidance.

November 12, 2014Alan KusinitzNews

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM346553.pdf

Oct

FDA IVD device level of concern.

October 27, 2014Alan KusinitzNews

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM419468.pdf

Oct

Final FDA Premarket Cybersecurity Guidance

October 2, 2014Alan KusinitzNews

/docs/FDACybersecurityPremarketGuidance1014.pdf

May

FDA Pre-Submission Program Presentation

May 1, 2014Alan KusinitzNews

/docs/FDAPre-SubPresentation-UCM387291.pdf

Mar

FDA: Requests for Feedback on Submissions Guidance

March 1, 2014Alan KusinitzNews

/docs/FDApresubmissionFeedbackGudiance.pdf

Oct

FDA Unique Device Identifier SW Requirements.

October 22, 2013Alan KusinitzNews

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

Oct

FDA Medical Device Free Online Training Modules

October 25, 2012Alan KusinitzNews

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

Oct

FDA Mobile Medical Apps Web page

October 1, 2012Alan KusinitzNews

http://bit.ly/2vTj0YB

May

FDA Inspection Issue Terminology

May 31, 2012Alan KusinitzNews

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

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...

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

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

Jun

IVD Software for Investigational Use Only-Draft

June 1, 2011Alan KusinitzNews

http://1.usa.gov/j87y0Q

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.”

Oct

FDA OSEL Public Domain Software

October 8, 2010Alan KusinitzNews

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHTransparency/ucm228613.htm

Jul

FDA Health Hazard Evaluation Form

July 2, 2010Alan KusinitzNews

/docs/FDA-HHE-Form0710-UCM126211.pdf

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Being Agile & Yet Compliant (Public)

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Backlog management
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3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

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

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future. Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply. Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

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Next public offering: TBD

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TBD

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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