fda registration medical device

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

LABEL COMPLIANCE

FDA labeling compliance requirements vary for each product. In general, information on the label must be truthful and not misleading, labels should include all the required information for the product category, wording and formatting should be easy for consumers to understand.

Below are basic requirements for each product category.

Food

Ingredient list
Nutrition information panel
Allergen warnings
Name and address of the manufacturer.
Net quantity of contents

Medical Devices

Intended use of the device
Directions for use
Warnings and precautions
Sterilization information (if applicable)
Manufacturer information

Drugs

Drug facts table.
Intended use of the drug with active ingredients concentration.
Warnings and precautions.
Directions of use
Inactive ingredients
Manufacturer information
Expiration date

Cosmetics

Principal Display Panel (PDP)
Product Name
Identity Statement
Net quantity and Ingredient list
Warning and Precautions

The FDA provides comprehensive guidance documents to help navigate the complexities of labeling compliance.

The FDA does not pre-approve labels, so manufacturers are responsible for ensuring compliance.

Liberty management Group, LTD as a leading FDA consulting firm provides assistance with Food, Drug, Medical devices and Cosmetics labeling compliance.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

FDA REGISTRATION RENEWAL TIMELINE

FDA registration renewal process is applicable to various FDA regulated products, including food facilities, medical devices, drugs, and more. However, specific renewal requirements and processes are needed based on the type of product or establishment.

Below are the timeline for FDA registration renewals.

Food Facilities: Food facilities must renew their FDA registrations every two years. The renewal period usually opens in October of even-numbered years. Registered food facilities need to submit a renewal registration between October 1^st and December 31^st of each even-numbered year.

Medical Devices: Owners or operators of establishments that manufacture, repackage, relabel, or remanufacture medical devices for commercial distribution must renew their registration annually with the FDA. This registration must be renewed between October 1^st and December 31^st each year and pay FDA fee.

Drug Establishments: Establishments involved in the manufacture, repackaging, relabeling, or salvaging of drugs must register with the FDA. Drug establishment registrations must be renewed annually between October 1^st and December 31^st every year.

Drug listings: All drug establishments must renew or certify their drugs listed in the previous fiscal years, between October 1st and December 31^st every year. During this renewal period companies must inform FDA about any update or changes in their drug listings. If they no longer market the drugs, it must be de-listed with marketing end date.

Liberty Management Group , as a leading FDA consultant will provide assistance with food registration biennial registration renewal, drug establishment registration renewal, medical device registration renewal and drug listing renewal.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

MEDICAL DEVICE LABELING REQUIREMENTS

US FDA regulates the labeling of medical devices to ensure the safety and effectiveness of these devices. Medical devices need to have proper labeling to provide healthcare professionals and patients with appropriate information about the devices intended use, risk, and direction of use.

Below are some of the main points in medical device labeling as per 21 CFR part 801.

Labeling Requirements: The device labeling must include all written, printed, or graphic materials accompanying a device like the packaging, adequate direction for use, user manuals, and any promotional materials.
Intended Use: Labeling must clearly indicate the intended use of the device which helps the healthcare professionals and patients understand its purpose and when it should be used.
Unique Device Identification (UDI): Medical devices must have a unique device identifier (UDI) that allows for easy tracking and identification. The UDI system helps in product recalls, post-market surveillance, and overall device traceability.
Risk Information: Labeling should include information about the device’s risks, contraindications, warnings, and precautions which is crucial for healthcare professionals and patients to understand potential adverse effects and how to mitigate them.
Instructions for Use: Detailed instructions for using the device safely and effectively should be provided. These instructions may include information on device preparation, administration, maintenance, and cleaning.
Storage and Handling: If specific storage conditions or handling instructions are necessary to maintain the device’s safety and effectiveness, these should be clearly outlined on the label.
Language and Formatting: Labels and instructions should be in a language that is easily understood by the intended users. The formatting should be clear, legible, and user-friendly.
Labeling Changes: Manufacturers must inform the FDA of any significant labeling changes to an approved medical device. These changes may require FDA review and approval.

It’s important for medical device manufacturers to follow FDA regulations to ensure the safety and effectiveness of their products. Failure to comply with labeling requirements can result in regulatory action, including product recalls and misbranding.

Manufacturers should also stay informed about any updates or changes in FDA regulations related to medical device labeling, as regulatory requirements may evolve over time.

Liberty Management Group, as leading FDA consulting firm provides assistance with FDA medical establishment registration, device listing and medical device labeling.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.us

MEDICAL DEVICES PRODUCT CLASSIFICATION

Medical devices are categorized into different classes based on their risk level and intended use. These classifications of U.S. Food and Drug Administration (FDA) to ensure the safety and effectiveness of these devices. Below are the classification of medical devices by FDA.

Class I: Low Risk

These are considered low-risk devices, typically involving minimal potential harm to the user.
Examples include elastic bandages, examination gloves, and most manual surgical instruments.
General controls are sufficientto provide reasonable assurance of safety and effectiveness.

Class II: Moderate Risk

These devices have a higher level of risk than Class I devices and require greater regulatory controls.
Examples include syringes, infusion pumps, and some diagnostic tests.
Special controls, such as performance standards, post-market surveillance, and patient registries, may be necessary to ensure safety and effectiveness.

Class III: High Risk

Class III devices pose the highest level of risk to patients and usually support or sustain human life, are implanted, or present potential unreasonable risk of illness or injury.
Examples include implantable pacemakers, heart valves, and automated external defibrillators.
These devices require pre-market approval (PMA) applications to demonstrate their safety and efficacy.

Before marketing a medical device, manufacturers must ensure they comply with the relevant regulatory requirements for the intended market. This might involve submitting various documentation, conducting testing, and obtaining the appropriate approvals or clearances from regulatory agencies.

Liberty Management Group, a leading FDA consulting group in the United States provides assistance with classification of devices and establishment registration, device listing, medical device label review, UDI listings and US agent service for foreign drug establishment firms.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us