FDA Pre-Submission Meeting Advice

Dobby1979

Involved In Discussions
#1
Hi All.

Happy New Year! When should we stop saying that? Maybe that is a question I could ask in my pre-sub!

The regulatory arena has always played second fiddle to Quality over my years in the industry but now I have the responsibility of getting approval for our new product!

I want to have a pre-sub meeting with the FDA so am looking at the FDA's CDRH 3514 form and also the guidance on what is required. Does anyone have any redacted templates that I could take a look at? It would be great to see what is required and the level of detail that is required for the application for a meeting.

Are there any housekeeping activities that I should have completed thus far, any fees that have to be paid? We have not yet registered with the FDA so I guess this should be one of the first things that we do?

Thanks for any help / advice
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
B How to submit Pre-submission to FDA? US Food and Drug Administration (FDA) 4
V Writing a Pre-Submission to the FDA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 47
Ronen E FDA publishes Draft Guidance on Med Dev Pre-Submission Program and Meetings with FDA Other US Medical Device Regulations 0
D New FDA guidance: Pre-Submission Program to replace the pre-IDE Program 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
somashekar Pre-Announced FDA 4 Day Inspection, Class 2 Devices, Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
Q FDA Consensus Standard for PMA (Pre-Market Approval) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S US FDA PMA (Pre-Market Approval) Process Flow Chart Example Other US Medical Device Regulations 1
J FDA Routine Inspection Pre-Anouncement - What will be checked? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
bio_subbu FDA issues draft PMA (Pre-Market Approval) Clinical Study Guidance 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B FDA PAI (Pre-Approval Inspection) Readiness Check List Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
W Pre-Announcement of FDA Field Inspection - Asian manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Scott Catron Contract Manufacturing Pre-Qualification? How much 'due diligence' to satisfy the FDA ISO 13485:2016 - Medical Device Quality Management Systems 7
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
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

Similar threads

Top Bottom