Can you guys help me figure out formatting a 510K

B

Bruce Banner

#1
Currently I have a submission written in word in a single file. I have a working table of contents that allows me to skip from section to section. It is currently paginated continuously (1-99).

I know I need to break it into sections and PDF it. What are the steps I need to take to get there? How do I deal with attachments along the way? Do I need to change my pagination?
TIA
 
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A

Al Dyer

#2
I have in the past had to get rid of the pagination and insert footer with applicable date then reset margins as appropriate. Set to Word Wrap to finish paragraphs then reset Page Setup and Orientation to where you need. I am currently working with Word 97.

Al...
 
#3
If you have a look at FDA guidance on Electronic Submissions (one of the 2 copies may be electronic) they have an example of a single file pdf submission with links.

See:
http: //www .fda .gov /MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/ucm134508.htm - DEAD 404 LINK UNLINKED
 
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B

Bruce Banner

#4
I have looked over that link, at the stage that I am at, how do I bridge it to the sectional PDF without ruining the pagination?
 

AnaMariaVR2

Trusted Information Resource
#5
Can you break it down based on the sections of your 510K?

My suggestion is to organize them by:

  1. sections
  2. content
  3. statistical data
  4. media files
  5. or whatever commonality/theme is relevant to your product's submission

QC the whole document before you submit it, agency reviewers are easily unnerved by broken hyperlinks or non-functional/missing/meaningless bookmarks.

Feel free to contact FDA if you continue to have problems or questions, they are very helpful:
Contacts
Any questions regarding FDA regulations or guidance should be directed to the appropriate division point of contact listed below.
ODE Divisions and Contacts
ODE Program Operations Staff
(301) 796-5640
Division of General, Restorative, and Neurological Devices
Assistant Director of Program Operations (ADPO): (240) 276-3737
Division of Cardiovascular Devices
Project Manager : (240) 276-4080
Division of Ophthalmic and ENT Devices
ADPO: (240) 276-4200
Division of Reproductive, Abdominal, and Radiological Devices
Project Manager: (240) 276-3636
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices
Project Manager: (240) 276-3700
OIVD Contacts
Eugene Reilly: (301) 796-6156
Patricia Beverly: (301) 796-6212
 
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Kevin Mader

One of THE Original Covers!
Staff member
Admin
#7
My advice is to establish your submission against the FDA guidance for submissions. While they will accept submissions not formatted in their suggested format, it usually leads to a round of questions where you end up pointing the reviewer to the information you already submitted. Given that the reviewers have large backlogs (like the rest of us), presenting the submission in the desired format expedites the process. Faster to market this way!! Good luck.

Kevin
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#10
You know the funny thing Marc: it's the same advice I'd give today. Even more so. Over the years, an organization I worked for migrated away from their nonstandard submission format to the standard format and reaped the benefits (fewer questions...faster to market, etc.). The Acceptance Checklists referenced by Ronen are essential these days; Refused to Accept is used otherwise. Given that folks want to be to the market yesterday, using the checklists (use the right one by the way) on the heals of a pre-submission meeting is almost mandatory in my opinion.
 
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