FDA Establishment Registration and Device Listing

Your FDA fast lane. We handle the paperwork, you focus on breakthroughs.

In the United States, owners and operators of businesses involved in the production and distribution of medical devices, drugs, combination products, dietary supplements, or cosmetics are required to register annually with the FDA. The tasks for FDA Establishment Registration and Listing for Medical Devices are administratively time consuming, tedious and often forgotten about, resulting in missed deadlines and lapses in registration certificates that could impact the ability to sell products.

Typically, facilities that are required to register with the FDA also need to list the medical devices that they manufacture on the US FDA Registration and Listing Database. This US FDA Establishment Registration and Listing for Medical Devices database helps the United States identify manufacturing establishments and the products they produce, which helps maintain better preparation for public health emergencies.

AlvaMed lets you focus on what matters: developing life-changing devices. We'll handle the rest, from registration to listing, ensuring a smooth FDA journey.

Our clients are happy to be references – we are happy to share their contact information when you meet with us.

Ready To Schedule A Call?

We look forward to discussing AlvaMed’s services with you.

FDA Establishment Registration and Device Listing FAQ's

This question arises frequently due to the diverse landscape of medical device entities. The following entities are required to register their establishments and list their devices with the FDA:

  • Domestic and foreign manufacturers of any medical device intended for commercial distribution in the U.S.
  • Initial importers of devices into the U.S.
  • Contract manufacturers and sterilizers that handle finished devices destined for the U.S. market.

Certain establishments, like distributors that don’t directly import devices, may have exemptions depending on their activities.

The amount of information varies based on the type of establishment and device. However, common requirements include:

  • Establishment details: Location, ownership, activities performed, contact information.
  • Device details: Device name, description, classification, labeling information, intended use.
  • Manufacturing and distribution information: Processes, procedures, facilities, suppliers.
  • Quality system documentation: Evidence of compliance with FDA quality system regulations (21 CFR Part 820).

Companies need to ensure all information submitted is accurate, complete, and up to date to avoid delays or potential compliance issues.

As of October 1, 2023, all establishments subject to registration must pay an annual fee of $7,653. Registration and listing updates must be submitted electronically between October 1st and December 31st of each year. Any changes to establishment or device information throughout the year should also be promptly reported to the FDA.

Missing deadlines or neglecting to pay fees can result in penalties and hinder timely market entry for device companies.

Eric Bannon

Senior Vice President of Regulatory and Clinical Affairs

Eric’s proven track record guiding companies through FDA registration and listing success stories speaks volumes. He’s the expert you need to navigate the regulatory landscape with confidence.

Eric isn’t just an FDA expert, he’s a strategic partner. His diverse industry experience gives you invaluable insights beyond just regulations, fostering informed business decisions.

Schedule time to meet with Eric to discuss how AlvaMed can help guide your FDA device registration process.