US FDA plans to launch new website

bio_subbu

Super Moderator
#1
Dear forum Users

The Food and Drug Administration has announced that it plans to launch a redesigned website, presumably in 2009. This should be good news for quality and regulatory professionals of the site. Hopefully, the guidance documents and other relevant information will be easier to find and databases will be easier to use. Here’s the brief announcement, stay tuned.

http://www.fda.gov/redesign/launch.html

Thanks and Regards
S. Subramaniam
 
Elsmar Forum Sponsor

Ajit Basrur

Staff member
Admin
#2
Yeah, I agree - the current design and web format is not user friendly like some other sites viz. TGA, Health Canada and so on.
 
S

sokku

#3
:thanx:
Dear forum Users

The Food and Drug Administration has announced that it plans to launch a redesigned website, presumably in 2009. This should be good news for quality and regulatory professionals of the site. Hopefully, the guidance documents and other relevant information will be easier to find and databases will be easier to use. Here’s the brief announcement, stay tuned.

Thanks and Regards
S. Subramaniam
Hi Subramaniam

Thank you so much for updating the information
 

bio_subbu

Super Moderator
#4
The homepage of aforesaid link/ location on CDRH Learn moved to http://www.fda.gov/Training/CDRHLearn/default.htm and check out CDRH Learn course list, it consists of a series of training modules describing many aspects of medical device and radiological health regulation, covering both premarket and post-market issues. This tool is intended to provide the medical device and radiological health industry with an information resource that is comprehensive, interactive, and easily accessible. Also, there is some training modules are available on the topics including;

1. Overview of Regulatory Requirements: Medical Devices
2. Quality System Regulation 21 CFR 820 Basic Introduction
3. Overview of the Premarket Notification Process – 510(k) 510(k) Overview
4. Premarket Notification 510(k) and 513(g): Request for Information Basic Introduction
5. 510(k) Format Guidance, Including Standards Form, and Extensions/Clinical Trial Form and 510(k)
6. 510(k) User Fees
7. 510(k) Third Party Review
8. "513(g)s".. Including 513(g) User Fees

Good things about these training modules are available in video with the slides. Hope you all find useful and informative.

Thanks and Regards
S. Subramaniam
 

bio_subbu

Super Moderator
#5
US FDA has updated the following prerecorded online training modules in CDRH Learn page

How to Get Your Electronic Product on the U.S. Market

Bioresearch Monitoring (BIMO)
BIMO Part 1a - Good Clinical Practice 101: An Introduction
BIMO Part 1b - Introduction to the Bioresearch Monitoring Program
BIMO Part 2a - The Sponsor: Responsibilities in Medical Device Clinical Trials
BIMO Part 2b - The Clinical Investigator: Responsibilities in Medical Device Trials
BIMO Part 2c - Computerized Systems Used in Medical Device Clinical Investigations
BIMO Part 3a - Institutional Review Board: Responsibilities in Making the Significant Risk and Non-significant Risk Device Determination
BIMO Part 3b - Institutional Review Board: Humanitarian Use Devices (HUDs)
BIMO Part 3c - Institutional Review Board: Compassionate and Emergency Use
BIMO Part 4a - Preparing for an FDA Medical Device Sponsor Inspection
BIMO Part 4b - Preparing for an FDA Clinical Investigator Inspection
BIMO Part 4c - Preparing for an FDA Institutional Review Board Inspection
BIMO Part 5a - Strategies for Sponsors to Build Quality into Device Research
BIMO Part 5b - Strategies For Clinical Investigators to Build Quality into Device Research

Also, planning to update training modules on CDRH Regulated Software, Recalls, Medical Device Reporting (MDR), Advanced Quality Systems, Imports and Supplier Controls.

CDRH Learn now provides an online course on Quality System Regulation in Mandarin Chinese.

Regards
S. Subramaniam
 
Thread starter Similar threads Forum Replies Date
Sidney Vianna FDA plans to use ISO 13485 for Medical Devices Regulation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
D FDA Information - Revising the Instructions for Use US Food and Drug Administration (FDA) 0
S Transitional Adolescent A and B - "CDRH PREMARKET REVIEW SUBMISSION COVER SHEET FORM FDA 3514" Medical Device and FDA Regulations and Standards News 1
B FDA requirement for CAPA Signoff ISO 13485:2016 - Medical Device Quality Management Systems 6
P MSDS for MVQ FDA White, Vinyl Methyl Silicone Rubber EU Medical Device Regulations 4
S Manufacturing Process FDA FOIA Medical Device and FDA Regulations and Standards News 3
S Manufacturing Process FDA FOIA US Food and Drug Administration (FDA) 4
S Mechanical Test Under FDA Freedom of Information Act Medical Device and FDA Regulations and Standards News 5
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12
C RA (Regulatory Assurance) Training (FDA) looking for resources Training - Internal, External, Online and Distance Learning 5
E FDA 513(g) Cover Letter US Food and Drug Administration (FDA) 5
S Records - Do's and don't' of record entries (FDA - 21 CFR 820) Records and Data - Quality, Legal and Other Evidence 13
B New Facility register with FDA Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
J FDA regulation on decorative contact lenses Medical Device and FDA Regulations and Standards News 5
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
F FDA classification for a mobile app Medical Information Technology, Medical Software and Health Informatics 3
Ed Panek IFU Contact Requirements - FDA and MDD/MDR US Food and Drug Administration (FDA) 1
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
P Writing a presubmission to the FDA prior to the De novo submission US Food and Drug Administration (FDA) 4
K FDA - Can we have more than 1 Initial Importer Medical Device and FDA Regulations and Standards News 4
K Two FDA questions regarding UDI (and potentially 803.52 MDR) Other US Medical Device Regulations 0
R Importers - For the FDA Registration/ Listing, is the CMO the importer? Medical Device and FDA Regulations and Standards News 6
Z Iterative development and FDA change requests IEC 62304 - Medical Device Software Life Cycle Processes 12
P FDA Approved Product Contact Parts ISO 13485:2016 - Medical Device Quality Management Systems 6
O Clarifying FDA definition of "finished device" and “capable of functioning” 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 7
JoCam FDA Registration for Sub-contract manufacturers Medical Device and FDA Regulations and Standards News 2
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
M Is IEC 60601-1-2 required by FDA for all electronic medical devices? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
E Contract manufacturer FDA requirements foreign company US Food and Drug Administration (FDA) 6
P Choice of FDA reviewer US Food and Drug Administration (FDA) 6
J Is Device Tracking Card an actual requirement under FDA regulation? Other US Medical Device Regulations 0
T Definition Human Use (FDA) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 7
K FDA 510k electrosurgery 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
J Leveraging FDA 510k Clearance for International Registrations Other Medical Device Regulations World-Wide 2
shimonv FDA News FDA guidance on Multiple Function Device Products (8/2020) Other US Medical Device Regulations 1
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
J FDA notification of address change US Food and Drug Administration (FDA) 2
N Usability testing required for FDA IDE (investigational device exemption)? Human Factors and Ergonomics in Engineering 8
A FDA Class Classification for a cabinet 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
L FDA Biocompatibility Requirements - Transitory Contact Other US Medical Device Regulations 1
Edward Reesor FDA DM and /or Class I Life Saving US Food and Drug Administration (FDA) 0
Watchcat FDA will not tolerate fraud…meaning what, exactly? Other US Medical Device Regulations 8
K FDA Premarket Cybersecurity Guidance - 4 questions Other US Medical Device Regulations 5
gunnyshore Form FDA 3500A MedWatch eSubmitter 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
Watchcat FDA Webinar Series - N95 Respirators Other US Medical Device Regulations 0
M Off-Label Use - Clarification of FDA Policy US Food and Drug Administration (FDA) 1

Similar threads

Top Bottom