FDA Launches Medical Device and Radiation-Emitting Product Transparency Web site

J

Juan Dude

#1
The U.S. Food and Drug Administration launched the Center for Devices and Radiological Health (CDRH) Transparency Web site today as part of the agency’s transparency initiative. The site will provide information about medical device and radiation-emitting product regulatory processes and decisions, and summaries of data that provide the rationale for agency actions.

The new Web site is part of an ongoing effort within CDRH, across the FDA and across the Department of Health and Human Services to enhance public communication and transparency. CDRH’s previous site provided information about approved products, industry guidance, medical device safety, and adverse event reports. On the new Web site, this and additional information are displayed in a more user-friendly format.

“The Center for Devices and Radiological Health Transparency Web site gives the public a window into our work,” said CDRH Director Jeffrey Shuren, M.D.. “It provides a closer and clearer look at what we do and why we do it.”
The site includes information related to the following topics:

· Premarket submissions for approved and cleared products – summaries of FDA’s review of the documents and data that companies submit to FDA when requesting clearance or approval to market a new or improved device, and the systems FDA uses to evaluate these submissions.

· Postmarket performance and safety – documents and data describing how well devices perform after they are on the market, and information about how FDA monitors medical device safety.

· Compliance and enforcement – official actions that FDA has taken in response to problems with devices or device companies.

· Science and research - research programs at CDRH or sponsored by CDRH.

· Educational resources – information to help industry and others understand CDRH requirements and processes.

· CDRH performance data – metrics about CDRH programs.

The site also features a searchable Total Product Life Cycle database, which integrates premarket and postmarket medical device information from multiple data sources into a single snapshot.

In the coming months, FDA will expand the CDRH Transparency Web site to include premarket approval and clearance reviews.

The Web site includes a feedback feature that will allow FDA to collect input and suggestions from the public about the information provided.

“The Web site launch is only a beginning for transparency efforts withint the Center for Devices and Radiological Health,” said Shuren. “We encourage the public to explore the site and share feedback so that we can continue expand our efforts and make improvements.”

Source: http :// www .fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm208969.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS
 
Last edited by a moderator:
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
My question is: Is more information going to become available, or is this just a matter of a different presentation / arrangement of the currently available info (as user-friendly as it may be)?

Cheers,
Ronen.
 
Y

yana prus

#3
Hi Ronen,

Looks like more information is going to become available, and already on April 20,2010 CDRH announced that under the CDRH Transparency Initiative, FDA is making available for the first time a sample copy of Pivotal IDE Study Summary (PIDS) form so that investigators and others can know the key elements necessary in an IDE application.

An investigative device exemption (IDE) allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data to support a Premarket Approval (PMA) application or a Premarket Notification (510[k]) submission to FDA. Data may include a substantive, or pivotal, phase III clinical trial study to support the safety and effectiveness of a medical device.

The Pivotal IDE Study Summary (PIDS) form is used by FDA reviewers to extract data more readily from IDE applications and to organize it in a way that forms the basis for approval.

The form can be found here:

http :// www. fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHTransparency/UCM206659.pdf - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS

Regards,

Yana
 
Last edited by a moderator:
Thread starter Similar threads Forum Replies Date
AnaMariaVR2 FDA launches consumer-friendly Web search for recalls US Food and Drug Administration (FDA) 0
Ajit Basrur FDA Launches Email Alert Subscription Service US Food and Drug Administration (FDA) 0
T FDA UDI Question - Class II Medical Device Other US Medical Device Regulations 1
P Does FDA require certification for quality system internal audit for auditor? Qualification and Validation (including 21 CFR Part 11) 1
I If i do not want to be an initial importer should i register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B When FDA Decision Summary opens? US Food and Drug Administration (FDA) 4
Ed Panek FDA Remote Regulatory Assessment (RRA) Overview 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
B What is the difference btw RUO vs IUO for IVD in FDA guidance ? US Food and Drug Administration (FDA) 12
B How to submit Pre-submission to FDA? US Food and Drug Administration (FDA) 4
L FDA & 21 CFR Part 11 Medical Device and FDA Regulations and Standards News 19
B A.I diagnostic software is considered as medical device in FDA? US Food and Drug Administration (FDA) 5
Ed Panek 2020 FDA Top Ten Observations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M FDA Requirements for Investigational Devices - Clinical Investigation & Shipping Medical Device and FDA Regulations and Standards News 0
Ed Panek Does this FDA Requirement Apply to international (not USA) distributors for USA based manufacturing companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B FDA Breakthrough Device can be overlapped with a designated device? US Food and Drug Administration (FDA) 6
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
S Examples of FDA acceptable Software Design Specification (SDS) Medical Device and FDA Regulations and Standards News 6
F Labelling to comply with both FDA and MDR US Food and Drug Administration (FDA) 6
Watchcat FDA vs NB Fees? Other US Medical Device Regulations 7
K FDA Registration and listing weird situation Medical Device and FDA Regulations and Standards News 4
D FDA Guidance on Computer Software Assurance versus 21 CFR Part 11 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
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 13
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

Similar threads

Top Bottom