Writing a Pre-Submission to the FDA

love02eat

Involved In Discussions
#31
Hi

Below is the table of contents we use for Pre-Subs.

1. Form 3514 CDRH Cover Sheet
2. Submitter Details
3. Device Description
4. Proposed Intended Use/Indications for Use
5. Previous Discussions or Submissions
6. Overview of Product Development
7. Proposed Predicate Device
8. Proposed Equivalence
9. Proposed Testing & Studies
10. Specific Questions - This is the key section, the better the questions, the better the answers!
11. Desired method for feedback

If you PM me, I'll send you a redacted copy of one of our pre-subs. This should give you an idea of the format and what to include.

FDA should give you assistance on whether the selected tests are appropriate, however they may not talk about specific endpoints. They will want to see all the results as part of the 510(k). However if you are creative in asking the questions, they can be very helpful.

Yes, use the eCopy to create the CD, and send it with a printed hardcopy to FDA. You should get an acknowledment from the post room in a couple of days saying its been accepted. The reviewer typically responds in 60-90 days. We always asked for written response, but you can ask for a conference call as well. Dont forget the 3514 CDHR Cover sheet :)

Chris

Hi Chris I was wondering if you could send your redacted copy of one of your pre-subs. as you stated I am having issues trying to private message you on the site- [email protected]
 
Last edited by a moderator:
Elsmar Forum Sponsor
#34
Hi @StevenJaeger
I am also going through the same process, being in a startup of medical device, not having experience in FDA.....not even pre-sub. Would you be willing to share the pre-sub template and cover letter with me? Sadly I am not able to PM you as well........

Hope everything is going well.
Cheers.
Betty
 

Ronen E

Problem Solver
Staff member
Moderator
#35
Hi @StevenJaeger
I am also going through the same process, being in a startup of medical device, not having experience in FDA.....not even pre-sub. Would you be willing to share the pre-sub template and cover letter with me? Sadly I am not able to PM you as well........

Hope everything is going well.
Cheers.
Betty
StevenJaeger is not an active user at Elsmar anymore.

I highly recommend you read the entire thread from the start. It holds some very important insights for you.
 

Watchcat

Trusted Information Resource
#36
being in a startup of medical device, not having experience in FDA
I'm curious as to where your company is in terms of starting up. There is a general consensus that investors will not invest in a medical device startup that has no regulatory expertise on board, because the failure rate is too high. Is your company still self-funded?
 
#37
I'm curious as to where your company is in terms of starting up. There is a general consensus that investors will not invest in a medical device startup that has no regulatory expertise on board, because the failure rate is too high. Is your company still self-funded?
Well.......this will be an another story that I cannot post in public. You get the point. Wish me good luck!!!!!!
 

Watchcat

Trusted Information Resource
#40
probably already doomed.
Well, you know, you can't say anything about this particular startup without knowing the secret story. Maybe it actually is a unicorn. But my general thought is that, if the rumor that CDRH is hoping to impose user fees for pre-subs is true, I wish it the best of luck with that effort.

CDRH is forced to spend way to much of its limited resources on startups that are going nowhere. It's gotten much worse lately, since the MDR seems to be driving most of them out of the EU. Lots of "MDR refugees" appear to have come knocking hopefully at CDRH's door...especially by way of the pre-sub, which they see as yet another opportunity for free advice.
 
Last edited:
Thread starter Similar threads Forum Replies Date
P Writing a presubmission to the FDA prior to the De novo submission US Food and Drug Administration (FDA) 4
Z Who is responsible for writing the validation of a new process? Manufacturing and Related Processes 7
S IAQG guidelines for AS9100 report writing AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
L Is writing out the ISO9001:2015 standard full name a requirement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 37
I Writing a Cosmetic Criteria for Switches Document Control Systems, Procedures, Forms and Templates 1
N GDP - Having to provide a reason when writing N/A? ISO 13485:2016 - Medical Device Quality Management Systems 1
R MDR 745/2017 keynote - I'm a student and I'm writing a thesis EU Medical Device Regulations 4
Q Writing Reports - Releasing Data into our Documentation System Document Control Systems, Procedures, Forms and Templates 1
P Secretly Auditing - Writing an audit report with observations based on my experiences Internal Auditing 12
A Self-study plan to improve fluency in English speaking, writing After Work and Weekend Discussion Topics 3
A Audit report writing course - Suggestions wanted Internal Auditing 9
J Required on-site training on writing deviations & root-cause analysis Training - Internal, External, Online and Distance Learning 3
dubrizo Audit Findings: Writing against Internal an ISO Clause Internal Auditing 10
A Writing an Internal Audit Report Finding for Employee Awareness of QMS Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Q Writing appropriate ISO 13485 Audit Report Findings Internal Auditing 15
J Technical Writing - Help Training Supervisors in the Basics Training - Internal, External, Online and Distance Learning 6
Pancho Writing, it is. How's this related to quality? The Reading Room 6
K Process Writing Software Suggestions for Internal Procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B Struggling With Writing PA (Preventive Action) Procedure Preventive Action and Continuous Improvement 11
x-files Procedure writing - Section - Related documents Document Control Systems, Procedures, Forms and Templates 8
S Brazilian Standard Compliance for Writing Instruments - Inmetro RoHS, REACH, ELV, IMDS and Restricted Substances 2
insect warfare Guidance on Writing in Plain English Quality Tools, Improvement and Analysis 24
C Writing a Sterilization Procedure when the Process is Subcontracted - ISO13485 Quality Management System (QMS) Manuals 1
C Writing Quality Management Plans for a Tender Submission Quality Manager and Management Related Issues 4
M Writing a Manufacturing Recall Procedure Document Control Systems, Procedures, Forms and Templates 3
M Writing a Minitab macro that can manipulate data in all columns Using Minitab Software 3
H Writing a Product Label Inspection Work Instruction Manufacturing and Related Processes 2
D Writing Minutes (Records) from Management Review Meetings Quality Manager and Management Related Issues 11
V Where to add SOP of writing a Technical File in ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 1
B Seeking help in writing marketing message Career and Occupation Discussions 12
G Writing up BRC audit non-conformance Internal Auditing 9
A Writing a Procedure for Validation of an Analytical Method General Measurement Device and Calibration Topics 5
AnaMariaVR2 Free Online 'Writing in the Sciences' Course Training - Internal, External, Online and Distance Learning 2
B Seeking help in writing an audit report that can stand on the court Internal Auditing 6
T Generic Guides for Procedure Writing Document Control Systems, Procedures, Forms and Templates 20
B Developing a Queue Management Procedure - Need some help writing a Proposal Quality Manager and Management Related Issues 2
Miner Writing Minitab Macros Using Minitab Software 6
N Writing our Standard Operating Procedures for Dietary Supplement Co - Examples wanted Document Control Systems, Procedures, Forms and Templates 7
B Writing a Customer Survey......Any tips? Customer Complaints 13
S Writing a Test Method Validation Procedure as well as Validation of Test Methods General Measurement Device and Calibration Topics 1
Moncia Writing a new Quality Manual for my new company - Need help ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B Having trouble writing a directive (procedure) that points to the right place ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
C NON-ISO Laboratory Scope Writing (for the Fire Marshal) Design and Development of Products and Processes 3
F Starting a Quality Control Program and writing a Quality Control Manual Quality Manager and Management Related Issues 10
sagai What is CD writing considered as - for Device-Only SW? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
AnaMariaVR2 [White Paper] Writing & Enforcing Your SOPs for GxP Compliance Success Document Control Systems, Procedures, Forms and Templates 0
S HACCP for Animal Feed - Writing a form and report about Animal Feed Food Safety - ISO 22000, HACCP (21 CFR 120) 10
J Acceptable Tolerance Range for Freezer - Writing an IQ/OQ for a Freezer US Food and Drug Administration (FDA) 2
K We subcontract the distribution of our products - Writing Scope Food Safety - ISO 22000, HACCP (21 CFR 120) 12
T Writing and Authorising Documents - Responsibilities and Authorities Document Control Systems, Procedures, Forms and Templates 3

Similar threads

Top Bottom