IAS has more than 15 years of experience in Medical Device FDA Registration & Listing. Establishments such as manufacturers, exporters, and importers of medical devices intended to be sold in the USA must register with the FDA. Those located outside of the USA need to designate an FDA US agent for better communication between parties.

Steps in US-FDA Device Registration

FDA Registration & Listing is possible only for 510k exempt or 510k / PMA cleared devices

STEP 1: DEVICE CLASSIFICATION: FDA will prioritize the medical device classification based on the risk they possess to the patient (Low, medium, high). Identify the product code for your device based on the risk and intended usage of the product. There are more than 6000+ product codes available for the medical device in the FDA database, IAS will help the applicant with the appropriate product code.

STEP 2: SPECIFIC & GENERAL CONTROLS: Medical device manufacturers and their supply chain have to follow the specific & general controls for their medical devices during manufacturing, packaging, holding, and processing. After the Product code is found, see if the device is 510k exempted or not. You can find the appropriate product code and classification in the FDA public database

STEP 3: FDA USER FEE CLEARANCE: Each entity required to register with FDA, should clear the medical device establishment registration Fee. The fees will be revised every year by the FDA. The current user fee for the fiscal year 2021 (1^st October 2020 to 30^th September 2021) is US$ 5546, recently on August 13^th FDA released the user fee for the medical device establishment registration fee for the fiscal year 2022 (October 1^st 2021 to September 30^th 2022) is US$ 5,672. The 9-digit DUNS Number is mandatory for every FDA applicant.

Through a secured payment gateway, IAS will pay the application fee for successful FDA registration.

STEP 4: US Agent for the foreign establishment (outside of the US). All medical device manufacturers and their supply chain for the FDA registration need IAS will assign US AGENT for the applicant as their emergency contact in case of any adverse event because of the medical device supplied in the US Market

Step 5: USER DETAILS – After clearing the FDA User fee, A portal for Applicant details will be uploaded for the references including, name, address, point of contact, US Agent, and Importer. A unique owner/operator number will be assigned to the applicant.

Step 6: PRODUCT LISTING – The number of products based on the application will be uploaded in the FDA portal, and other information such as trade secrets, formulas, and designs will be maintained in the IAS archive.

Step 7– A unique registration number will be assigned to the applicant within 60 days after successful registration, the applicant does not have to worry, in the meantime can use the Owner/operator number for their US Based Business. Please refer to the image below in the FDA portal.

STEP 8: REGISTRATION RENEWAL – Usually an establishment has to submit a registration renewal application at least 3 months before the expiry of its list. IAS can guide you through this complex activity and help in US-FDA device re-registration.

Fees and Timeline

IAS charges the following fees

Step 1 to Step 4 — US$ 750 (up to 3 products)
US Agent Fee — US$ 600
US FDA Government Fee –US$ 5672.

Time frame: Less than a week.

Specific & General Controls for the Medical Device

US-FDA has classified devices into three categories

class I – low-risk categories of devices
class II – moderate-risk categories of devices
class III – high-risk categories of medical devices.

General Controls are

Adulteration;
Misbranding;
Device registration and listing;
Premarket notification;
Banned devices;
Notification and repair, replacement, and refund;
Records and reports;
Restricted devices; and
Good Manufacturing Practices.

Special controls are

Performance standards
Post-market surveillance
Patient registries
Special labeling requirements
Premarket data requirements
Guidelines

With a vast experience in the medical industry, IAS professional will assess their Management based on the General & specific controls for their compliance through various certification schemes like ISO 13485, GMP, 21 CFR 820

Class I: Devices that are not intended to support or sustain life and which operate in such a way that body contact with the device itself is not expected during its effective lifetime, e.g., powered wheelchairs. All class 1 medical devices are subjected to General controls under US federal law

Class II: This category of devices is intended to support or sustain life, or is of substantial importance in preventing impairment of human health, and which may present a potential risk of illness or injury. This category includes intra-uterine contraceptive devices (IUD). All Class II medical devices are subjected to General & special controls Under US Federal Law

Class III: A Class III device is one that does not achieve its principal intended action by pharmacological, immunological, or metabolic means and which may pose a potential risk to health. This category is broken into three sub-categories:

Class III devices that are life-sustaining or life-supporting (life support only allowed in an emergency situation where no alternative device is available). Examples include ventilators, pacemakers, and heart valves.
Class III devices that present more than a minor health risk and which require general controls to assure safety and effectiveness of use. These include items for sterilization, cutting, or cauterization; other devices used in surgery; implantable articles including sutures (except individually packaged sterile surgical sutures); and needles used to give injections.
All class III devices are subjected to PMA (Premarket Approval) an important process for scientific evaluation to ensure the safety and effectiveness of Class III devices.

For more information, please contact IAS directly by submitting the contact form