#cdrh

[freyrsolutions]

What is an eCopy? An eCopy is an electronic version of your medical device submission created and submitted on a compact disc (CD), digital

[pacificbiosafety]

FDA Initiative to Reduce Unnecessary Radiation Exposure

FDA Initiative to Reduce Unnecessary Radiation Exposure

From the desk of USFDA- Mar 2010.

In 2010, Food and Drug Association’s (FDA) Center for Devices and Radiological Health (CDRH) launched an Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging and held a public meeting in response to data highlighted by the National Council on Radiation Protection and Measurements.

The principles highlighted in this initiative are:

Jus…

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[quality-thoughts]

The Center for Devices and Radiological Health or CDRH will focus on encouraging medical device innovation and speeding clinical trials in the coming years, according to its 2014-2015 Strategic Priorities report released Feb. 5. To help encourage that innovation, CDRH says it’s going to work to improve the consistency of the Investigational Device Exemption (IDE) […]

[davidrussellschilling]

What is Experiential Learning?

What is Experiential Learning?

C O N T E N T S: KEY TOPICS Often, Experiential Learning takes place outside of the classroom and in the field where students apply their knowledge to hands-on experiences.(More…) POSSIBLY USEFUL Through UB’s Be More Leadership and Community Engagement program and the Rural Appalachian Improvement League, students take on a powerful community-building and learning experience in a cold,…

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[nationallawreview]

Center for Devices and Radiological Health (CDRH) Schedules January 2016 Cybersecurity Workshop

Center for Devices and Radiological Health (CDRH) Schedules January 2016 Cybersecurity Workshop

Center for Devices and Radiological Health, CDRH has scheduled a cybersecurity workshop entitled, “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity,” on January 20-21, 2016 (see here for the Federal Register announcement). Background and Workshop Context As we discussed in a previous post, cybersecurity vulnerability is an increasing concern as medical devices are becoming…

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[regulatorydoctor-blog]

FDA CDRH MDUFA III Performance Report

FDA CDRH MDUFA III Performance Report

The United States Food and Drug Administration (FDA) The Center for Devices and Radiological Health (CDRH)

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MDUFA III (FY 2013-2017) Performance Report for 4th Quarter of FY 2015

November 9, 2015

Table of Contents

Section 1: PMA Originals and Panel Track Supplements

DAGRID Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices

DCD…

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[regulatorydoctor-blog]

FDA Workshop Materials for Medical Device Patient Labeling

FDA Workshop Materials for Medical Device Patient Labeling

Public Workshop – Medical Device Patient Labeling, September 29-30, 2015

The FDA has posted  workshop materials for the Medical Device Patient Labeling, the workshop of which was held on September 29-30, 2015.

FDA access link is at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm455361.htm

If you wish to submit your comments regarding the public workshop, you may do so until 

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[regulatorydoctor-blog]

FDA Notifies the Industry Concerning Tyvek Products Made by Dupont

FDA Notifies the Industry Concerning Tyvek Products Made by Dupont

FDA Notifies the Industry Concerning DuPont’s New (Transition) Tyvek Products FDA/CDRH Email

We are writing to notify you that on the basis of data submitted by DuPont, including testing of the functional performance of the product during medical device sterilization and maintenance of package integrity over time, the FDA has determined that DuPont’s new (Transition) Tyvek® products are…

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