Can’t say thanks enough for digging through your old files – but for your suggestion to revisit this topic, we’d still be looking at 1,360 devices for E&L and biocomp testing. So, thank you.
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.
Can’t say thanks enough for digging through your old files – but for your suggestion to revisit this topic, we’d still be looking at 1,360 devices for E&L and biocomp testing. So, thank you.
CereVasc, LLC
Mark and his group have consistently provided exceptional deliverables in a timely and cost effective manner.
MedTech Client
AlvaMed completed the registration for the company and coached the company president in the FDA registration process.
CASE STUDY
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:
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:
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.
As a former FDA reviewer and experienced regulatory leader, Alexia has helped companies successfully navigate a wide range of FDA submissions and regulatory challenges.
Her combination of agency, industry, and consulting experience allows her to provide practical guidance that helps companies align with FDA expectations, reduce regulatory risk, and advance products efficiently toward commercialization.
Schedule a meeting with Alexia to discuss your regulatory strategy, upcoming submission, or FDA interactions and learn how AlvaMed can support your development program.
