USFDA CDRH MEDICAL DEVICES WEBINARS : Download CDRH Industry Basics Workshop (All Day Webinars) – November 4, 2014

Date: 5th Nov 2014

Webinar: CDRH Industry Basics Workshop

Summary: This workshop (presented by webinar) will provide information on the fundamental concepts of medical device regulations.

The workshop will feature five sessions, each of which will consist of a presentation followed by a question and answer session with a panel of experts. Participants will be able to email or call us with your questions during each session.

Participants can choose to participate in any and/or all of the sessions. Each session will begin precisely at the scheduled time. Click link to view.download printable slides of respective webinar

• 10:00-11:00 am: Investigational Device Exemption (IDE) Program
• 11:00-12:00 noon: 510(k) Program
• 12:00-1:00 pm: De Novo Program
• 2:00-3:00 pm: Corrective and Preventive Actions (CAPA) Basics
• 3:00-4:00 pm: Electronic Medical Device Reporting (eMDR) 21 CFR Part 803

Target Audience included experts and professionals from Medical Device Industry, Medical Device Developers, Medical Device Industry Associations.

USFDA CDRH Webinar on Distinguishing Medical Device Recalls from Medical Device Enhancements conducted on 5th Nov 2014..

Webinar: Distinguishing Medical Device Recalls from Medical Device Enhancements – Final Guidance

Summary: The guidance clarifies for manufacturers how to determine when changes to a device constitute a recall and when they are considered a product enhancement.

The guidance contains clear definitions and practical examples to help manufacturers distinguish a recall from an enhancement. Correctly identifying a change to a device as a recall reduces the time between identification of a device defect/failure and public notification.

Clarifying when a change to a device represents a recall or an enhancement will help manufacturers better understand when reporting device changes to the FDA is required.

View/Download Printable Slides of the Webinar CLICK HERE

USFDA CDRH Industry Basics Workshops All Day Webinar on Nov 4, 2014

Webinar: CDRH Industry Basics Workshop

Summary: This workshop (presented by webinar) will provide information on the fundamental concepts of medical device regulations.

The workshop will feature five sessions, each of which will consist of a presentation followed by a question and answer session with a panel of experts. Participants will be able to email or call us with your questions during each session.

Participants can choose to participate in any and/or all of the sessions. Each session will begin precisely at the scheduled time.

• 10:00-11:00 am: Investigational Device Exemption (IDE) Program
• 11:00-12:00 noon: 510(k) Program
• 12:00-1:00 pm: De Novo
• 2:00-3:00 pm: Corrective and Preventive Actions (CAPA)
• 3:00-4:00 pm: Electronic Medical Device Reporting (eMDR)

Target Audience: Medical Device Industry, Medical Device Developers, Medical Device Industry Associations

Webinar Details

Date: November 4, 2014 

Time: 10:00 AM – 4:00 PM, Eastern Time – To ensure you are connected, log-in by 9:45 AM.
Webinar Link: http://fda.yorkcast.com/webcast/play/c369da3174e945db99747267beeb2a551d
Audio Dial-In: 800-527-1401 (to ask questions during the Q&A sessions)

USFDA Final Guidance and Webinar on “Distinguishing Medical Device Recalls from Medical Device Enhancements”

USFDA had issued a issued a final guidance document titled “Distinguishing Medical Device Recalls from Medical Device Enhancements.” The guidance clarifies for manufacturers how to determine when changes to a device constitute a recall and when they are considered a product enhancement. 

What's inside Guidance?

The guidance contains clear definitions and practical examples to help manufacturers distinguish a recall from an enhancement. Correctly identifying a change to a device as a recall reduces the time between identification of a device defect/failure and public notification. Clarifying when a change to a device represents a recall or an enhancement will help manufacturers better understand when reporting device changes to the FDA is required.

Webinar on the above Guidance Details:

Date: November 5, 2014

Time: 1:30 PM – 3:00 PM, Eastern Time
To ensure you are connected, log-in by 1:15 PM.

To hear the presentation and ask questions: Dial: 1-888-469-0882; passcode: CDRH

To view the slide presentation during the webinar:
https://www.mymeetings.com/nc/join/
Conference number: PW9036971, Passcode: CDRH
Following the webinar, a transcript, recording and slides will be available at: http://www.fda.gov/Training/CDRHLearn/default.htm

USFDA CDRH Webinar on "Medical Devices in the Home: Design Considerations and Guidance for Industry"

USFDA CDRH has uploaded recorded webinar, printable slides and transcript for the Webinar

"Medical Devices in the Home: Design Considerations and Guidance for Industry"

Please view/download

Recorded Webinar

Printable Slides (PDF)

Transcripts (PDF)

For other webinars posted by CDRH on Medical Devices - CLICK HERE

USFDA CDRH Transcript for Webinar "FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations"

USFDA CDRH has uploaded printable slides and transcript for the webinar "FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations" conducted on 4th SEP 2014.

For Recorded Webinar Video CLICK HERE
For Printable Slides Download CLICK HERE
For Transcript Download CLICK HERE

USFDA will host a webinar and Q&A Session on “How to use CDER Direct to submit Registration and Listing Structured Product Labeling (SPL) files”.

On Tuesday September 16, 2014 at 1:00 pm EDT, CDER SBIA will host a webinar and Q&A session entitled “How to use CDER Direct to submit Registration and Listing Structured Product Labeling (SPL) files”. This webinar will provide a brief demo of CDER Direct, a new software application to assist companies in submitting drug registration and listing submissions.

  

To register for this Event, please go the following link: https://collaboration.fda.gov/sbia0916/event/registration.html

(Registration password needs to be 8 characters and alphanumeric)

Note: Your registration acknowledgement will include the webinar access link. 

Audio will broadcast from your computer speakers. Please mute your microphones (to reduce audio feedback) during the webinar.

Closed captioning will be provided.

Please note: There is a user capacity limit for this webinar. For those who cannot enter the webinar, please know that it will be recorded and a link will be posted to this page:  

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm070334.htm

Questions/Comments can be submitted live via a Q/A chat window.

For questions concerning the webinar, please contact CDER SBIA at:  (866)-405-5367 | (301)-796-6707 

CDER SBIA webinar series: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm070334.htm

CDER SBIA Webinar on “How to use CDER Direct to submit Registration and Listing Structured Product Labeling (SPL) files”...

USFDA CDER SBIA has scheduled a webinar for industry on CDER SBIA Webinar on “How to use CDER Direct to submit Registration and Listing Structured Product Labeling (SPL) files”.

For detailed information click on below links:

On Tuesday September 16, 2014 at 1:00 pm EDT, CDER SBIA will host a webinar and Q&A session entitled “How to use CDER Direct to submit Registration and Listing Structured Product Labeling (SPL) files”. This webinar will provide a brief demo of CDER Direct, a new software application to assist companies in submitting drug registration and listing submissions.

  

To register for this Event, please go the following link: https://collaboration.fda.gov/sbia0916/event/registration.html

(Registration password needs to be 8 characters and alphanumeric)

Note: Your registration acknowledgement will include the webinar access link. 

Audio will broadcast from your computer speakers. Please mute your microphones (to reduce audio feedback) during the webinar.

Closed captioning will be provided.

Please note: There is a user capacity limit for this webinar. For those who cannot enter the webinar, please know that it will be recorded and a link will be posted to this page:  

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm070334.htm

Questions/Comments can be submitted live via a Q/A chat window.

  

For questions concerning the webinar, please contact CDER SBIA at:  

(866)-405-5367 | (301)-796-6707

  

CDER SBIA webinar series: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm070334.htm  

FDA issued a final Guidance Document on “FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations.”

The Food and Drug Administration (FDA) has recently issued a final guidance document, “FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations.” The FDA is committed to improving US patient access to new devices by strengthening and streamlining the clinical trial enterprise so that clinical trials are conducted in the US in an efficient, cost-effective manner while maintaining appropriate patient protections.
The final guidance describes the FDA’s decision-making and communications regarding applications from companies that want to conduct medical device clinical trials in the US. It also describes more flexible options for clinical study approvals that allow clinical studies to begin sooner while ensuring patient protections.
 The final guidance outlines:
Processes to allow more efficient study enrollment
 Provides information regarding the FDA’s decision-making processes to improve predictability of the regulatory process
Introduces communication intended to improve the transparency of FDA’s decision-making process
On September 4, 2014 the FDA will hold a webinar to explain the guidance and to provide a forum for asking questions you may have. Registration is not necessary.
Webinar Details:
Date: Thursday, September 4, 2014
Time: 1:00 PM – 2:30 PM, Eastern Time
To ensure you are connected, log-in by 12:45 PM.
To hear the presentation and ask questions: 
Dial: 888-972-7807; passcode: 1405152

To view the slide presentation during the webinar:
https://www.mymeetings.com/nc/join/
Conference number: PW8306690
Passcode: CDRH
Following the webinar, a transcript, recording and slides will be available at: http://www.fda.gov/Training/CDRHLearn/default.htm