What is USA FDA Device Registration?

USA Food Regulatory Agency of the Department of Health and Human Services has taken steps to protect the public from the food supply and related emergencies by enforcing the Bioterrorism Act from December 12, 2003.

• Must submit establishment registration information, with consent to inspect the facility at any time as per the FDA protocol
• Must renew food facility registrations every other year, with consent to suspend registration if found reasonable cause as per the protocol
• Each food facility should have its own 11-digit registration number. If the same management has multiple facilities for manufacture and export to the USA, each of the facilities is required to register and obtain different food facility 11-digit registration numbers
• FDA Food Facility registration is simple, but it is tiring and confusing for those doing it for the first time.

Benefits of USA FDA Device Registration

Reduced risk


Access to new business

Improved efficiency

Customer satisfaction

Helps you stand out from your competitors

Certified USA FDA Device Video

Who can be certified USA FDA Device Registration?


Testing Kits

Medical Furniture

Medical Equipment

IVD Instruments

Surgical Instruments

Dental Implants

Ortho Implants

Disposable Syringes Needles

Document required for USA FDA Device Registration

  • Technical File, Product Master File (TCF)
  • Product Testing
  • System Manual
  • System Procedure
  • Policy
  • Objectives
  • Mission & Vision
  • Plant Master File
  • Standard Operating Procedure (SOP)
  • Checklist
  • Forms
  • Formats
  • Records

The extent of Documented Information differs as per:

  • Product and it's uses
  • Testing requirement of products
  • Directive in which product classified
  • Self Certification or Compliance Certification
  • Notify body Certificate

Role of Shamkris and Process of USA FDA Device Registration

Shamkris adopts a results-oriented approach to compliance product certification, A simple & practical method of product certification organization in timely compliance and fulfills the product certification requirement. Shamkris support 100% on documentation required to comply with product certification either by self-certification or notify body certification to depend on directives.

The implementation process is described below:

Step 1

Phase I

• Selecting the Medical Device and Models for USFDA approval

Step 2

Phase II

• Identify device code and Regulation Number along with verification of predicate device, indication and technology

Step 3

Phase III

• 510K compilation incorporating the pre-submission

Step 4

Phase IV

• US Agent appointment

Step 5

Allocation of FDA 11 Digit Food Facility Registration Number.

• Modify the 510K and provide additional supporting documentary evidences as per FDA review comments.

Domestic and foreign facilities that manufacture, process, pack, or hold food, as defined in 21 CFR 1.227, for human or animal consumption in the United States must register with FDA. food– borne illness; and • Quickly notify facilities that may be affected.