FDA Medical device registration

WHO NEEDS TO REGISTER, LIST AND PAY FOR MEDICAL DEVICE REGISTRATION

Companies including foreign and domestic establishments that are engaged in manufacturing and marketing medical devices including export only devices are required to register yearly with US FDA. Registered establishments are required to list the devices along the activities made on the devices too.

The following are the businesses that are required to register and list the devices.

Manufacture: Establishments that makes by chemical, physical, biological, or other procedures, any article that meets the definition of “device”.

Contract Manufacture: Establishments that manufacture the device as per other establishment specifications.

Specification Developer: Companies that develop specifications for a device that is distributed under the establishment’s own name but performs no manufacturing.

Contract Sterilizer: Provides a sterilization service for another establishment’s devices.

Repackage- Establishments that package the finished devices into different containers excluding shipping containers.

Relabel- Establishments that change the content of the labeling that they have received from the original manufacturer for distribution under the establishment’s own name.

Foreign Export: Establishments that export the devices from a foreign country including the devices manufactured in the United States.

Re-manufacture: A person or establishment who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use.

Export only device: Companies who manufactures the devices that are sold only in foreign countries and manufactured in the United States.

Complaint file establishment: Establishments that manage only complaints.

Initial Importer: Any company who furthers the marketing of a device from a foreign manufacturer to the person who makes final sale of the device to the consumer but does not perform any other action on the device.

Establishments that are registered with US FDA must renew their registration every year between October 1^st and December 31^st every year by paying FDA’s MDUFA fees.

Liberty Management Group, as a leading FDA consultant, helps with MDUFA payment, FURLS account creation, medical device establishment registration, device listings and renewals.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.us

FDA SMALL BUSINESS DETERMINATION (SBD) – AN OVERVIEW

FDA defines “small business” which includes all its affiliates with gross sales or earnings not exceeding $100 million, $30 million, or $1 million, for the most recent tax year, are eligible for small business fee waivers.

Qualified small businesses, with all affiliates with gross earnings of not more than $100 million are eligible for reduced fees for certain type of CDRH submissions that are required to pay user fee by the businesses.

Below are the application types that are eligible for reduced small business fees.

Premarket Notification (510K)
De Novo request
Premarket Approval Application
Biologics License Application (BLA)
Product development Protocol (PDP)
Premarket Reporting (PMR)
PMA/BLA supplements and PMA annual reports
30-day-Notices
513(g) Requests for Information

Small business is eligible for “First premarket application/report” fee waives if the business and affiliate gross income are no more than $30 million for first their PMA, PDP, PMR, or BLA application.

FDA has introduced a new small business fee waiver program for MDUFA fees.

This fee waiver is not applicable for initial registration.

Companies are eligible for small business fee waivers if they satisfy all the requirements below.

business, including its affiliates, has gross receipts or sales of $1 million or less in the most recent tax year,
Must prove that paying the registration fee would represent a financial hardship (for example, proof your business is in active bankruptcy), and
Proof that they had paid the registration fee in a prior fiscal year.

To apply for SBD, companies must get organization ID and submit form 3602N to FDA.

Liberty Management Group Ltd, as leading FDA consultants will provide assistance in creating user fee account, completing and checking form 3602N and providing assistance with Medical device establishment registration and renewals.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

FDA ACNE REGULATIONS

USFDA regulates acne products and treatments under drugs, cosmetics, and medical devices.

Acne Drug Products

OTC Monograph Compliance: OTC acne treatments products must comply with the FDA’s ” Topical Acne Drug Products for Over-the-Counter Human Use ” (Monograph ID: M006). This monograph specifies the active ingredients, dosage forms, labeling, and conditions under which these products can be marketed without a prescription.
Active Ingredients: Commonly used active ingredients in OTC acne products include benzoyl peroxide, salicylic acid, and sulfur. Each active ingredient has specified concentration ranges and usage guidelines.
Labeling Requirements: The FDA mandates specific labeling for OTC acne products, including indications for use (e.g., “for the “management/treatment of acne”), directions, warnings, and any potential adverse effects.
New Ingredients: If an acne product contains an active ingredient which is not FDA’s OTC monograph, then it must go through the New Drug Application (NDA) process to be approved.
cGMP compliance: All acne products must be manufactured in compliance with cGMP regulations.

Acne Treatment Medical devices

Device Classification: Acne treatment devices (e.g., light therapy devices) are classified into Class I, Class II or PMA devices based on their risk to patients. Most acne devices fall under Class II, which requires 510K clearance by proving that the device is substantially equivalent to a legally marketed device.

Cosmetic Acne Products

Definition: If a product is marketed as a cosmetic (e.g., cleansers, toners, or non-active ingredient-based products claiming to “reduce the appearance of acne”), it is not subject to the same requirements as drugs or devices. However, it must still be safe to use and properly labeled.
Label Claims: Cosmetic products must not make drug claims on the labels.

Liberty Management Group, as a leading FDA regulatory consulting firm, can guide the companies to determine how the products are regulated and help them with the registration process.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

510K EXEMPTION REGULATIONS

The FDA 510(k) exemption regulations refer to certain medical devices that are not required to undergo the 510(k) (premarket notification process). These exemptions are designed to streamline the regulatory process for devices that are considered to pose minimal risk to patients and users.

Generally, medical device manufacturers must submit a 510(k) premarket notification to the FDA to demonstrate that their device is substantially equivalent to a legally marketed device (predicate device). But certain low-risk devices are exempt from the 510(k) process. These exemptions can apply to both Class I (general controls) and some Class II (special controls) devices.

Class I Devices: Most Class I devices are exempt from 510(k) requirements, subject to certain limitations. These devices are typically considered less critical devices and poses minimal risk.

Class II Devices: Some Class II devices are also exempt, but this is less common. These devices are considered to pose a moderate risk.

Even if a device is 510(k) exempt, it must still comply with other regulatory requirements such as:

Registration and listing
Labeling requirements
Good Manufacturing Practices (GMPs)

Special Controls: For some Class II devices, specific special controls must be met even if the device is exempt from 510(k).

Devices are classified into various panels, each covering a specific medical specialty, to determine if they are exempt. FDA maintains a database where anyone can check if the device is 510K exempt or not.

Liberty Management Group Ltd, provides assistance with medical device establishment registration, device listings, label review and US agent service to foreign facilities.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.ushttp://www.fdahelp.us

DUNS NUMBER

A DUN’S number is a unique nine-digit identifier assigned by Dun & Bradstreet (D&B), a business credit bureau. The DUNS Number is location specific. So, each physical location of an entity such as branches, divisions, and headquarters may be assigned a DUN’S number separately.

To market food, drugs and medical devices products in the United States, companies must have DUNS number.

Food: All domestic and foreign food facilities what wants to sell their food products in the US will be required to provide a Unique Facility Identifier (UFI) when registering with FDA or renewing food facility registration with FDA. DUNS number is the only acceptable UFI recognized by FDA.

For new registrations – Once the registration is submitted, FDA will verify the accuracy of UFI. FDA will not confirm the registration or provide a registration number until verification is complete.

For biennial renewals – Once the renewal is submitted, FDA will verify the accuracy of UFI. FDA will not confirm the renewal until verification is complete.

Drugs: US FDA will directly pull the company information only from FDA’s DUNS portal. So, companies who want to register with FDA must obtain DUNS first and then proceed with registration.

Medical Devices: Even though for now, DUNS number is not mandatory to register, to submit Unique Device Identification (UDI), DUNS is a mandatory requirement.

DUNS number for FDA purposes is free of cost. Facilities registering with FDA must obtain a DUN’S number first. DUNS requests may take up to 30 days.

Liberty Management Group, as leading FDA consultant provide assistance with DUNS number lookup and FDA registration and renewals.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

STEPS INVOLVED IN MEDICAL DEVICE REGISTRATION

The FDA medical device registration process involves multiple steps to ensure the device meets safety and regulatory standards.

Registration Requirements: The FDA classifies devices into various risk categories Class I, II, III based on their complexity and potential risks. Based on their classification, the registration requirements vary. For critical devices, first they must get 510K clearance or PMA and then register.

Pay the Registration Fee: The FDA requires an annual registration fee for device establishments. Companies can make the payment by creating a user fee account with FDA and obtain a Payment Identification Number (PIN) and Payment Confirmation Number (PCN).

Obtain a FURLS Account: The FDA uses the Facility and Registration Listing System (FURLS) for device establishment registration and product listing. Companies must create a FURLS account to complete the registration process.

Register the Facility: Register the establishment that manufactures or distributes the medical device with the FDA through FURLS. This involves providing details like owner information, facility location, and the type of activities your establishment performs related to the device.

Device listing: Once the facility is registered, list the specific medical device in FURLS. Devices can be identified with the product codes which indicate if the device needs premarket notification or 510k number. If product code needs 510K clearance or PMA, then the device must be listed with appropriate 510K or PMA numbers.

All medical device establishments must renew their registration between October 1^st and December 31^st every year if they want to market the device in the next FY.

Liberty Management Group, as a leading FDA consultant, helps with MDUFA payment, FURLS account creation, medical device establishment registration, device listings and renewals.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

U.S AGENT

Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a food, drug, medical device, and cosmetics imported into the United States must identify a U.S. agent for that establishment.

Information about a foreign establishment’s U.S. Agent must be electronically using the FDA FURLS system or CDER/ESG and is part of the establishment registration process. Each foreign establishment may designate only one U.S. agent. The foreign establishment should provide the name, address, telephone, and e-mail address of the U.S. agent.

Responsibilities of a U.S. agent

The U.S. agent must either reside in the U.S. or maintain a place of business in the U.S and they cannot use P.O. BOX as the address. U.S agents must be available to answer the phone or have an employee available to answer the phone during normal business hours.

The responsibilities of the U.S. agent are limited and include:

Assisting FDA in communications with the foreign establishment, meaning that function as a mediator between the client and the FDA.
Responding to questions concerning the foreign establishment’s products that are imported or offered for import into the United States,
Assisting FDA in scheduling inspections of the foreign establishment and
If FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be equivalent to providing the same information or documents to the foreign establishment.

Liberty Management Group, a leading FDA consulting firm provides assistance with US agent services all foreign food, drug, medical devices and cosmetics establishments.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

WHO NEEDS TO REGISTER WITH FDA?

The US Food and Drug Administration (FDA) is responsible for protecting public health by ensuring the safety, efficacy, and security of human and animal drugs, biological products, medical devices, food (including animal food), cosmetics, and tobacco products. It also regulates electronic products that emit radiation.

Foods:

The FDA regulates the safety, labeling, and quality of all other food products except for meat, poultry, and egg products, which are regulated by the US Department of Agriculture (USDA).

In general, it includes Fresh and processed foods, Dietary supplements, Bottled water, Food additives, Infant formulas, fruits, and vegetables.

Drugs:

The FDA regulates the safety, effectiveness, and quality of all human and animal drugs, which includes prescription and over-the-counter drugs, homeopathic drugs, active pharmaceutical ingredients and vaccines and other biological products.

Medical Devices:

The FDA regulates the safety, effectiveness, and quality of all medical devices used in humans which includes a wide range of devices, from simple bandages to complex surgical implants.

Cosmetics:

The FDA regulates the safety of all cosmetics, including makeup, skincare products, and hair care products, Hair care products, lotions, and moisturizers.

Products are categorized based on the label claims and regulated according to intended use.

Liberty Management Group Ltd, as a leading FDA consulting firm providing assistance with FDA registration of food, drug, medical devices and cosmetic products.

Liberty Management Group Ltd, as a leading FDA consulting firm will provide assistance with above all regulatory requirements.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.ushttp://www.fdahelp.us

CERTIFICATE TO FOREIGN GOVERNMENT (CFG) – NE (Certificates to Foreign Government for Device Not Exported from the United States.)

Certificates to Foreign Government for Device Not Exported from the United States (CFG-NE) is document issued by FDA issued for legally marketed devices in the U.S that are manufactured by the companies located outside of the United States and are in compliance with the regulations of FD&C act.

Certificates to Foreign Government for Device Not Exported from the United States (CFG – NE) is a self-certification process. By completing the required form, a firm confirms that it is registered with FDA and listed their device with FDA, that each product is legally marketed in the U.S. and is not the subject of an open recall, that all facilities involved in the manufacturing process are complying with the FDA’s regulations, and that each product is not being exported from the U.S.

Requirements to get the Certificates to Foreign Government for Device Not Exported from the United States (CFG – NE)

The manufacturing facility must have a valid medical device establishment registration and must be located outside of the United States.
All devices must be listed with the FDA.
The devices must have cleared Premarket notification (510K) or Premarket Approval (PMA) unless it is exempted by the regulation.
The device should meet all the medical device labelling requirements as of 21 CFR 801 and 809.
The device should be manufactured in accordance with 21CFR 820 also known as Good Manufacturing practice unless it is exempted by the regulation.
Each device(s) identified is not the subject of an import alert, recall, seizure, injunction, or the subject of any other FDA enforcement action.
Manufacturers, contract manufacturers, and contract sterilizers involved in the manufacturing process, if applicable, have been identified

Certificate to Foreign government can be requested through CECATS system. It is a voluntary electronic system that allows the manufacturers to request export documents online. CECATS can be accessed by logging into the FDA Furls account.

The fees for export certificate from CDRH are $175 for the first certificate and $85 each for additional certificate upon the request from the customer.

Liberty Management Group, a leading FDA consulting firm provides assistance with FDA Medical device registration, device listing and certificate to foreign government application.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.us

REGISTRATION DE-ACTIVATION

The consequences of not renewing US FDA registration can be significant, depending on the type of facility that operates and the products they manufacture.

Food facilities:

Expired registration: If your registration expires, the FDA will consider it a violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This can lead to:

Warning letters: The FDA may issue a warning letter outlining the violation and requesting corrective action.

Seizure of products: The FDA may seize the products if they believe that the products are manufactured in an unregistered facility or pose a public health risk.

Injunctions: The FDA may seek a court order to prevent from continuing to operate your facility until you come into compliance.

Loss of business: Potential customers and suppliers may be hesitant to do business with a facility that is not in good standing with the FDA.

Medical device establishments:

Expired registration: Like food facilities, an expired registration for a medical device establishment is a violation of the FD&C Act and can lead to:

Warning letters: The FDA may issue a warning letter outlining the violation and requesting corrective action.

Refusal to approve marketing applications: The FDA may refuse to approve marketing applications for medical devices manufactured in unregistered establishments.

Import restrictions: The FDA may restrict the import of medical devices manufactured in unregistered establishments.

Drugs

Expired registration: Like other registration, an expired registration for drug establishments is also violation of FDA&C Act and can lead to:

Warning letters: The FDA may issue a warning letter outlining the violation and requesting corrective action.

Refusal to approve marketing applications: The FDA may refuse to approve marketing applications for drugs manufactured in unregistered establishments. They will consider the drug as misbranded and de-activate all the drugs listed FDA.

Import restrictions: The FDA may restrict the import of drugs manufactured in unregistered establishments. Also, they may seize the products if they believe they are manufactured in an unregistered facility or pose a public health risk.

Liberty Management Group, as a renowned FDA consulting firm can help the companies in renewing the food establishment, drug establishment and medical device establishments in a timely manner.

Sudha

Regulatory Consultant

Email: office@libertymanagement.us