Medical Device Questionnaire for FDA Regulations

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https://staging.registrarcorp.com/fda-medical-devices/questionnaire/
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Questionnaire
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Flow Type
- medical_device_general
- food_safety_wizard
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- debug
Provide your contact information
Country*
Legal Company Name*
Contact Name*
Email*
Phone*
Mobile Phone
My devices are intended to be shipped to the following countries for sale:*
- United States
- Canada
Which FDA requirements would you like assistance with?*
- Food Safety / HACCP Plan
- Foreign Supplier Verification Program
- Food Defense Plan
- Recall Plan
- Seafood / Juice Importer Verification Program
- Supply Chain Program
- Dietary Supplement MMR
- I was referred to this Wizard by someone
Who referred you?*

Provide your company address information
Facility Street Address*
City*
State/Province/Region
Postal Code

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Scroll to the right to view additional information.
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Devices
Common Name Device Manufacturer Proprietary Name Intended Use Company Function Label (see file below) Website 510k Predicate Device
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Device Information
Provide information about your device
List the common (usual) name of the device*
(Example: Adhesive Tape or Bandages, Manual Toothbrush, etc.)
List the proprietary name(s) of the device*
(Example: Ubber Brand Adhesive Tape, Acme Brand Toothbrush, etc.)
What is the intended use of the device?*
Device Manufacturer*
Identify your company's function related to this device*
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Label Information
Do you have a label for this product?*
- Yes
- No
Upload your product label
Drop files here or

Max. file size: 50 MB.
Upload your product label
Drop files here or

Max. file size: 50 MB.
Upload your product label
Drop files here or

Max. file size: 50 MB.
Upload your product label
Drop files here or

Max. file size: 50 MB.
Upload your product label
Drop files here or

Max. file size: 50 MB.
File Uploads
Upload any relevant documentation on your device.
Device Files
Upload a device brochure, specification / fact sheet, or user manual
Drop files here or

Max. file size: 50 MB.
Device Files
Upload a device brochure, specification / fact sheet, or user manual
Drop files here or

Max. file size: 50 MB.
Device Files
Upload a device brochure, specification / fact sheet, or user manual
Drop files here or

Max. file size: 50 MB.
Device Files
Upload a device brochure, specification / fact sheet, or user manual
Drop files here or

Max. file size: 50 MB.
Device Files
Upload a device brochure, specification / fact sheet, or user manual
Drop files here or

Max. file size: 50 MB.
Provide any website advertising this device
For example, an ecommerce listing or product webpage
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510(k) Information
Have you previously submitted a 510(k) submission to FDA?*
- Yes
- No
510(k) Number*
If you believe your device may require a 510(k) Premarket Notification, provide a "
predicate device
A predicate device is a medical device that is substantially equivalent to your device with respect to: intended use, design, energy used or delivered, materials, performance, safety, effectiveness, labeling, biocompatibility, standards, and other applicable characteristics.
" and its 510(k) number. Otherwise, leave the fields below empty.
Predicate Device
Predicate Device 510(k) Number
Provide information for the chief technical officer for this device.
(This must be an employee or consultant with sufficient expertise to provide complete and accurate technical information concerning the device)
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Phone

Which of the following best describes your operation?*
- I manufacture / process food products
- I import food products into the United States
- I manufacture and import food products for consumption in the United States

Which of the following best describes your global annual sales and U.S. market value of the food you manufacture, process, pack, hold or import?*
(averaged over the previous three years, including affiliates and subsidiaries)
- Less than $1 million
- $1 million - $2.5 million
- $2.5 - $10 million
- More than $10 million
Do you have a Preventive Controls Qualified Individual or a HACCP qualified individual?*
- Yes
- No
Do you have a qualified individual to perform FSVP responsibilities?*
- Yes
- No
Select all activities conducted at this location*
Specify Other*

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Products
Product Name Intended Consumer Type of Food Varieties All Intended Uses Storage Packaging Owner of Product at Entry Product Manufacturer Likely Requirements
Basic Product Information
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Estimated Requirements
Provide information about your food or beverage product. (You may add additional products later in the form.)
Provide the name of the product
Indicate the type of food
Specify Other
List all flavors / varieties of this product that you are handling for consumption in the U.S.
(separate varieties by comma or line)
Specify the Manufacturer of this Product
Who owns the product at time of entry?
- My company
- Another Company
- Fulfilled by Amazon
Identify the owner of the product at entry
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Product Details
Indicate the intended consumer of the product
- Humans
- Animals
Select all intended uses of the food
Specify Other*
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Storage/Packaging
Select how the foods will be stored and distributed
- Frozen
- Refrigerated
- Shelf-stable
Type of packaging for finished product
Specify Other*
File Uploads
Upload the food safety documentation specific to this product. (Please upload files in English if possible)
Upload the food safety documentation specific to this product from your suppliers. (Please upload files in English if possible)
Upload Food Safety Files
Upload product labels, descriptions/specifications, flow diagrams, hazard analysis, and Food Safety/HACCP plans.
Drop files here or

Max. file size: 50 MB.
Upload Food Safety Files
Upload product labels, descriptions/specifications, flow diagrams, hazard analysis, and Food Safety/HACCP plans.
Drop files here or

Max. file size: 50 MB.
Upload Food Safety Files
Upload product labels, descriptions/specifications, flow diagrams, hazard analysis, and Food Safety/HACCP plans.
Drop files here or

Max. file size: 50 MB.
Upload Food Safety Files
Upload product labels, descriptions/specifications, flow diagrams, hazard analysis, and Food Safety/HACCP plans.
Drop files here or

Max. file size: 50 MB.
Upload Food Safety Files
Upload product labels, descriptions/specifications, flow diagrams, hazard analysis, and Food Safety/HACCP plans.
Drop files here or

Max. file size: 50 MB.

Review your devices and submit
Review your products and submit. To make changes to a product or upload new documents, simply click the product's "edit" button.
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Medical Device Questionnaire for FDA Regulations

Device Information

Label Information

File Uploads

510(k) Information

Basic Product Information

Product Details

Storage/Packaging

File Uploads

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100% Juice
Bakery
Beverage
Chocolate and Candy
Dairy
Dietary Supplements
Dressing and Condiments
Egg
Food Additives
Fruits and Vegetables
Grains
Herbs and Spices
Infant Formula
Nuts and Seeds
Oils
Produce
Seafood
Snack Foods
Soups
Sweeteners
Other

Common Name	Device Manufacturer	Proprietary Name	Intended Use	Company Function	Label (see file below)	Website	510k	Predicate Device

Product Name	Intended Consumer	Type of Food	Varieties	All Intended Uses	Storage	Packaging	Owner of Product at Entry	Product Manufacturer	Likely Requirements