FDA Registration for medical devices

IBC has expertise in FDA Registration & Listing of Medical Devices. Medical device producers, importers, and exporters that want to sell their products in the USA must register with the FDA. Those who are not US citizens must appoint an FDA US agent in order to improve communication.

Steps in US-FDA Registration

Only 510k exempt or 510k/PMA certified devices are eligible for FDA Registration & Listing.

STEP 1: DEVICE CLASSIFICATION: The FDA will classify medical devices as Low, Medium, or High Risk depending on the risk they pose to the patient. Based on the risk and planned use of the product, find the product code for your device. The FDA database has more than 6000+ product codes for medical devices, and IBC will assist the applicant in choosing the right one.

STEP 2: Particular & GENERAL CONTROLS: During the production, packing, holding, and processing of their medical devices, medical device makers and their supply chain must adhere to the particular & general controls. Check to check if the gadget is 510k exempt after locating the product code. The FDA’s public database has the proper product code and categorization.

(STEP 3) FDA USER FEE CLEARANCE :
The medical device establishment registration fee must be paid by any entity that is required to register with the FDA. The FDA will update the fees each year. The FDA has announced the user charge for the medical device establishment registration cost for the fiscal year 2022 (October 1 to September 30) would be US$5,672. The present user fee for the fiscal year 2021 (1st October 2020 to 30th September 2021) is US$5546. Every FDA applicant must have a 9-digit DUNS number.

IBC will pay the application cost upon successful FDA registration using a secure payment method.

STEP 4: US Agent (outside of the US) for the overseas establishment. FDA registration is required for all medical device makers and their supply chains. If there is a problem with the medical equipment sold to the US market, IBC will designate US AGENT for the applicant as their emergency contact.

Step 5: USER data – Following payment of the FDA User Fee, a portal for applicant data, including name, address, point of contact, US Agent, and importer, will be made available for references. To each application, a special owner/operator number will be given.

Step 6: PRODUCT LISTING – A list of goods based on the application will be published to the FDA site, along with additional data such trade secrets, formulations, and designs.

Step 7: The application won’t need to worry; they may utilise the Owner/operator number for their US-based business in the meantime. The applicant will receive a special registration number within 60 days after a successful registration. Please refer to the FDA gateway image below.

STEP 8: REGISTRATION RENEWAL – Typically, a business must submit a registration renewal application at least three months before the list it is registering expires. IBC can help with US-FDA device re-registration and can guide you through this challenging process.

Costs and Schedule

IBC levies the subsequent fees.

Steps 1 through 4: US$750 (for a maximum of 3 goods)
US Agent Fee: 600 USD
Government Fee for the US FDA: $5672.
Time frame: A week or less.

General and Specific Medical Device Controls

Devices have been divided into three categories by the US-FDA.

Devices in class I are low-risk categories.
devices in class II, the moderate-risk categories
class III – high-risk medical device categories.

Basic controls include

Adulteration; Misbranding;

Device registration and listing, Premarket notice, Banned devices, notice and repair, replacement, and refund, Records and reports, Restricted devices, and Good Manufacturing Practises are some of the other terms used in the device industry.

Standards of performance

Are special controls.
After-market monitoring
Registries of patients
Unique labelling specifications
Guidelines for premarket
Data obligations

IBC professionals will evaluate their Management based on the General & Specific controls for their compliance through several certification schemes like ISO 13485, GMP, and 21 CFR 820. These professionals have extensive expertise in the medical field.

Class I: Are not designed to support or maintain life and are operated in such a way that over their useful lifetimes, bodily contact with the device itself is not anticipated, such as motorised wheelchairs. Under US federal law, all class 1 medical devices are subject to general restrictions.

Class II:Are those that are meant to support or sustain life or are crucial in preventing harm to human health but may also provide a risk of disease or damage. The intrauterine contraceptive device (IUD) falls within this category. Under US federal law, all Class II medical devices are subject to general and particular restrictions.

Class III: A Class III device is one that may represent a danger to health and does not accomplish its primary intended function by pharmacological, immunological, or metabolic mechanisms. There are three subcategories within this category:

Life-sustaining or life-supporting Class III equipment (life support is only permitted in an emergency circumstance when no other device is available). Heart valves, pacemakers, and ventilators are a few examples.
Class III devices are those that pose a greater danger to health than a minimal risk and therefore need broad restrictions to ensure user safety and efficacy. These include instruments for sterilisation, cutting, or cauterization, additional surgical tools, implantable goods like sutures (apart from separately packed sterile surgical sutures), and injection needles.
Premarket Approval (PMA), a crucial procedure for scientific examination to guarantee the safety and efficacy of Class III devices, is a requirement for all products in this category.
Please fill out the contact form to get in touch with IBC directly if you want additional details.