# data[].attributes.attachment_link.authors[].name
Center for Devices and Radiological Health

# data[].attributes.attachment_link.title
Training Curriculum for Third-Party Reviewers

# data[].attributes.attachment_link.description
Training Curriculum for Third-Party Reviewers

# data[].attributes.headline
Keynote Speaker | David A. Kessler, M.D.

# data[].attributes.subject
Keynote Speaker | David A. Kessler, M.D.

# data[].attributes.attachment_link.title
"I've lost my life;" Women question Essure birth control, claim device harmed them (Part 2)

# data[].attributes.attachment_link.title
The Bleeding Edge | Trailer [HD] | Netflix

# data[].attributes.attachment_link.title
The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It

# data[].attributes.attachment_link.description
Buy The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It on Amazon.com ✓ FREE SHIPPING on qualified orders

# data[].attributes.attachment_link.description
750 million+ members | Manage your professional identity. Build and engage with your professional network. Access knowledge, insights and opportunities.

# data[].attributes.headline
The Special 510(k) Program: Final Guidance

# data[].attributes.subject
The Special 510(k) Program: Final Guidance

# data[].attributes.attachment_link.readable_text
Download Software

To download the FDA eSubmitter software, click on the following link. Save the installation zip file to your computer and extract the jinstall.exe file. Double-click the jinstall.exe file to run the installation. Follow the instructions provided in the installation wizard.

Persons with disabilities having problems accessing the PDF files may call 1-877-CTP-1373 for assistance.

System Requirements

Windows Operating System

Adobe Acrobat Reader v5.0 or greater (for attaching files)

Software capable of viewing HTML, such as a Web browser, Microsoft Word or Adobe Acrobat (full install version, not the Reader)

30 MB of disk space

Installation Instructions

Before installation, uninstall any other versions of the eSubmitter software. If you do not have a prior version of eSubmitter, proceed to installing the current version of FDA eSubmitter.

To uninstall the previous versions of eSubmitter, use Windows Explorer to navigate to the eSub folder of the installed drive (e.g., C:). Then, double-click on the uninstall.exe and follow the instructions provided. (If you do not see uninstall.exe, locate and double-click to open the JExpress file folder. Then, double-click on the uninstall.bat and follow the instructions provided.)

To install the latest version of the FDA eSubmitter software, navigate to the software's download directory and double-click on the jinstall.exe. Following the instructions of the installer, the FDA eSubmitter software will be installed locally.

If you're using a proxy server to connect to the Internet, then you will need to change the application's properties file (eSubmission.properties) to reference the server. See your System Administrator for help in changing the properties file. The properties file is located in the application's JExpress subdirectory (Program Files\eSubJExpress).

Add the following switches before the -cp switch:

-DproxySet=true -DproxyHost= [proxy_host] DproxyPort = [proxy_port]
(replace [proxy_host] and [proxy_port] with the appropriate information for your configuration).

If the proxy server requires a user id and password, add the following two properties to the update.control file that's also located in the JExpress subdirectory:

proxyUserName=
proxyPassword=

To launch FDA eSubmitter, go to the Start menu and select Programs>FDA Submissions Software>eSubmitter.

NOTE: If your computer is locked because of administrator privileges, you will have issues receiving automatic updates to the FDA eSubmitter software. See your System Administrator.

# data[].attributes.attachment_link.description
To download the FDA eSubmitter software, click on the following link. Save the installation zip file to your computer and extract the jinstall.exe file. Double-click the jinstall.exe file to run the installation. Follow the instructions provided in the installation wizard.

# data[].attributes.attachment_link.title
Class 2 Device Recall The Greenfield Vena Cava Filter

# data[].attributes.headline
Case Study: How Is My Medical Device Classified?

# data[].attributes.subject
Case Study: How Is My Medical Device Classified?

# data[].attributes.headline
Webinar – 510(k) Third Party Review Program: Final Guidance

# data[].attributes.subject
Webinar – 510(k) Third Party Review Program: Final Guidance

# data[].attributes.headline
Tips and Tricks: Starting Your Own Continuing Medical Education Course

# data[].attributes.subject
Tips and Tricks: Starting Your Own Continuing Medical Education Course

# data[].attributes.headline
Continuing Medical Education Activity Application 

# data[].attributes.subject
Continuing Medical Education Activity Application 

# data[].attributes.attachment_link.provider_name
CASP - Critical Appraisal Skills Programme

# data[].attributes.attachment_link.title
CASP Checklists - Critical Appraisal Skills Programme

# data[].attributes.attachment_link.description
View or download our range of critical appraisal tools & checklists for free including our RCT, qualitative and quantitative checklists.

# data[].attributes.attachment_link.title
Identification of predicate creep under the 510(k) process: A case study of a robotic surgical device

# data[].attributes.attachment_link.description
The FDA’s 510(k) process for medical devices is based on “substantial equivalence” to devices clearedpre-1976 or legally marketed thereafter, known as predicate devices. In the last decade, several high-profile device recalls have drawn attention to this regulatory clearance process and researchers have raised questions about the validity of the 510(k) process as a broad clearance mechanism. One of the issues raised is the risk of predicate creep, a cycle of technology change through repeated clearance of devices based on predicates with slightly different technological characteristics, such as materials and power sources, or have indications for different anatomical sites. This paper proposes a new way to identify potential “predicate creep” through the use of product codes and regulatory classifications. We test this method by applying it to a case study of a Robotic Assisted Surgery (RAS) device, the Intuitive Surgical Da Vinci Si Surgical System. We find that there is evidence of predicate creep using our method, and discuss implications of this method for research and policy.

# data[].attributes.headline
510(k) Third-Party Review Program Overview

# data[].attributes.subject
510(k) Third-Party Review Program Overview

# data[].attributes.attachment_link.title
510(k) Third Party Review Program Overview

# data[].attributes.attachment_link.description
In this overview, Greg Pishko will give some background about the Third Party Review Program and then talk about device specific training modules posted on CDRH Learn.

# data[].attributes.body
Evidence & Curriculum Design Months 1–6
Literature synthesis, learning objectives, CME framework

# data[].attributes.body
•CME Accreditation & Funding Months 7–8
Accreditation application, budget alignment

# data[].attributes.body
•Course Development Months 9–10
Module creation, instructional design, checklist integration

# data[].attributes.body
Platform Integration & Pilot Launch  Months 11–14
LMS integration + 510k Academy website (LIVE)

# data[].attributes.attachment_link.description
510k Academy is a comprehensive resource for medical device professionals navigating FDA’s 510(k) clearance pathway. Access FDA documents, expert analysis, and policy explainers.

# data[].attributes.body
Evaluation & Outcomes Measurement Months 15–18
Pre/post testing, knowledge gain, clinical impact

# data[].attributes.wish_content.attachment_props.alternative_text
testing, knowledge gain, clinical impact

# data[].attributes.body
Expansion & Partnerships Ongoing
Academic, clinical, and industry collaboration

# data[].attributes.body
Dissemination & Keynote Engagement Ongoing
Conference presentation, keynote speakers, national reach

# data[].attributes.attachment_link.provider_name
The Curbsiders - An Internal Medicine Podcast

# data[].attributes.attachment_link.authors[].name
The Curbsiders - An Internal Medicine Podcast

# data[].attributes.attachment_link.description
Starting January 1, 2024, VCU Health Continuing Education* will charge a CME credit claim fee of $10.00 for new episodes. This credit claim fee will help to cover the costs of operational services, electronic reporting (if applicable) and real time customer service support. Episodes prior to January 1, 2024 will remain free. *Due to

# data[].attributes.attachment_link.title
Patients Filing Lawsuits Over IVC Filter Complications

# data[].attributes.attachment_link.description
IVC Filters (for blood clots) have been linked to serious complications and risks. Discover why patients are pursuing financial compensation and lawsuits.

# data[].attributes.headline
The impact of patient, intervention, comparison, outcome (PICO) as a search strategy tool on literature search quality: a systematic review

# data[].attributes.subject
The impact of patient, intervention, comparison, outcome (PICO) as a search strategy tool on literature search quality: a systematic review