Category: fda registration-drug-medical device

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

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

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

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

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 1st and December 31st 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 1st and December 31st 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 1st and December 31st every year.

Drug listings: All drug establishments must renew or certify their drugs listed in the previous fiscal years, between October 1st and December 31st 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 AND DRUG RENEWAL REQUIREMENTS

Medical Devices

According to FD&C act Title 21 CFR part 807, all domestic and foreign medical device establishments that are involved in the production and distribution of medical devices intended to be used in the United States are required to renew their registration annually between October 1st and December 31st every year.  Federal government has authorized FDA to collect an annual establishment fee for medical device establishments.  List of establishment that need to renew and pay the fees can be found at https://www.fdahelp.us/Pdf/Drug.pdf .  The establishment registration fee is not eligible for a reduced small business fee.

 All foreign manufacturers must identify at least one importer in their registration before they send the shipment to the United States.  In turn, US importers also need to identify the foreign manufacturer at the time of renewal of registration. FDA will verify the manufacturer registration status at the port of entry by comparing the submitted information with CDRH’s establishment registration and listing database. If the information does not match, FDA will ask for more information and also may detain the product at the port if the firm lacks required registration and listing.

Drugs

As per FD&C act Title 21 CFR part 207, all domestic and foreign drug establishments registered with US FDA must renew their registration every year between October 1st and December 31st. The renewal of registration must be submitted to FDA in SPL format via FDA’s Electronic Submission Gateway (ESG) with the same original set id used in original registration.  Drug establishments need to update the registration at the time of renewal if there is any change is company information.

All foreign drug manufacturers must update their registration with US importer information at the time of renewal of registration.  FDA will verify the registration status of manufacturer at the port of entry by comparing the submitted documents with CDER Drug Establishments Current Registration Site. FDA may consider the drug products misbranded and detain it at the port, if the firm did not renew the registration.

Drug Listing Renewal

As a new regulation started in FY 2016, FDA will deactivate drug listing records in its database that are not properly listed in accordance with FDA requirements as these drug listings are not certified as being active and up to date or the manufacturing establishment is not registered with FDA. FDA wants the registrants to notify if the drugs are not in commercial distribution and ask them to put an end marketing date in the listings. Also, FDA requires firms to submit drug listings updates if there are any material changes to information previously submitted which includes change in manufacturing establishment(s). Drugs with inactivated listing records cannot be legally marketed or imported in the US. The Blanket listing no change certification must be submitted to FDA between October 1st and December 31st every year.

Liberty Management Group Ltd, a leading FDA consulting group provides assistance with medical device establishment registration renewal, drug establishment registration renewal, drug listing renewal and US agent service to foreign countries.

Sudha S

Regulatory Consultant

Mail: Office@libertymanagment.us

www.fdahelp.us

COMBINATION PRODUCTS

A combination product is a product consist of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.

As per FDA 21 CFR 3.2, a combination product is defined as

  • A product consist of two or more elements for example, drug/device, biologic/device, drug/biologic or drug/device/biologic that are physically, chemically combined to form a single unit which is often referred as “single-entity” combination product. Some examples of single entity combination products are Syringes, insulin injector pen metered dose inhalers.
  • Two or more products packaged together in a single packet or as a package that has drug/device products, device/biologic products or biologic/drug products are often referred as “co-packaged” combination product. Examples of co-packages combination products are first aid kits containing devices(band aids and gauze) and drugs (antibiotic ointments and pain killers)
  • A drug/device/biological product packaged separately that as per the label it is intended for use only with an approved individually specified drug/device/biological product, where both are required to attain the intended use and upon the approval of proposed product, the labeling of the approved product needs to be changed are referred as “cross-labeled” combination product. Examples of cross-labeled combination product is Photosensitizing drug and activating laser/light source
  • Any investigational drug/device/biological products packaged separately and as per its proposed labeling it can be used only another individually specified investigational drug/device/biological product where both are required to have the same intended use which are referred as another type of “cross-labeled” combination product.

Section 503(g) (1) of FD&C act requires FDA to assign a component of the agency to primary jurisdiction for the regulation of combination product.  The assignment of jurisdiction is based on the “primary mode of action” of the combination product.  For example, if the primary mode of action of a combination product is a biological product, then it is assigned to FDA component which is responsible for the premarket review of that biological product.

Combination products are marketed under an authorization type connected with the constituent part that gives the primary mode of action (PMOA) for the combination product.  For example, it should have NDA or ANDA if it has drug PMOA, a biologic license application (BLA) if it has a biologic PMOA or PMA (Pre-market approval) or 510K clearance if it has a device PMOA.

GMP requirements are applicable to all combination products that has drug/device/biologic constituent part.

Liberty Management Group, a leading FDA consulting firm in the United States will provide assistance with FDA registration of combination products.

Sudha S

Regulatory Consultant

Mail : office@libertymanagement.us

http://www.fdahelp.us

WHAT DOES FDA REGULATES

The Food and Drug Administration (FDA) is in charge for protecting public health by assuring the safety and efficacy of human and animal drugs and biologics, medical devices, tobacco products, human food and animal food for consumption, cosmetics, and electronic products that emit radiation. It also provides precise science based health information to the public.

FDA regulates the following which is a list of traditionally-recognized products that comes under FDA’s regulatory authority.

Foods, which includes

  • Dietary Supplements
  • Bottled water
  • Vegetable and fruit products
  • Food additives
  • Infant formulas
  • Other food products (some of the food products are regulated by USDA such as meat, poultry and egg products).

Drugs, which includes

  • Over the counter (OTC) drugs
  • Prescription drugs( Brand name and generic)

Medical devices, which includes

  • Simple items from bed board and cane
  • Dental devices
  • Surgical devices, implants and prosthetics
  • Complex medical devices such as intraocular lens and pacemakers.

Vaccines, Blood & Biologics, which includes

  • Allergenics
  • Blood and Blood products
  • Tissue and it products
  • cellular and gene therapy products

Radiation emitting products, which includes

  • Laser products
  • X-ray equipment
  • Ultrasonic therapy equipment
  • Mercury Vapor lamps
  • Sunlamps

Cosmetics, which includes

  • skin moisturizers and cleansers
  • Color additives found in makeup and personal care products
  • Nail polish and perfumes

Animal & Veterinary, which includes

  • Pet foods
  • Livestock feeds
  • Animal drugs and devices

Tobacco Products, which includes

  • Cigarattes
  • cigarette tobacco
  • roll-your-own tobacco
  • smokeless tobacco

Alcohol products are regulated by The Department of the Treasury’s Alcohol and Tobacco Tax and Trade Bureau (TTB) which monitors the production, importation, wholesale distribution, labeling and advertising.

Consumer Product Safety Commission(CPSC) ensure the safety of consumer goods such as children toys, power tools, cigarette lighters, household chemical products and products that cause a  fire, electrical, chemical or mechanical hazard.

Meats, Poultry and certain egg products are regulated by US Department of Agriculture (USDA).

The Environmental Protection Agency (EPA) regulates many traits of pesticides which determines the amount of pesticide used during cultivation, processing and how much can remain on the food we buy. EPA also regulates drinking water, which develops the national standards of drinking water from municipal tap water to limit the level of impurities.

Liberty Management Group, a leading FDA consulting firm provides assistance with registration of food, drug, medical devices and cosmetic companies and also provides assistance with US agent service to foreign companies.

Sudha S

Regulatory Consultant

Mail: office@libertymanagement.us

www.fdahelp.us

CERTIFICATE TO FOREIGN GOVERNMENT (CFG)

Certificate to Foreign Government (CFG) is document prepared by FDA issued for legally marketed devices in the U.S that are in compliance with the regulations of FD&C act.

Medical devices that are legally marketed in the United States can be exported to anywhere in the world without getting approval from FDA.  Although FDA does not restrict the export of legally marketed, certain importing countries require a certification from FDA stating that the firm, or its devices are in compliance with U.S. FDA regulations. Foreign government will ask for official assurance that the products exported to their countries are in compliance with US FDA regulations such Good manufacturing Practice (GMP) requirements. In that cases, U.S companies can request a certificate to foreign government (CFG) also known as Certificate of Free sale to FDA.

The certificate to foreign government (CFG) 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 being exported from the U.S.

Requirements to get the Certificate to Foreign Government (CFG)

  1. The manufacturing facility must have a valid medical device establishment registration
  2. All devices must be listed with FDA
  3. The devices must have cleared Premarket notification (510K) or Premarket Approval (PMA) unless it is exempted by the regulation.
  4. The device should meet all the medical device labelling requirements as of 21 CFR 801 and 809.
  5. The device should be manufactured in accordance with 21CFR 820 also known as Good Manufacturing practice unless it is exempted by the regulation.

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

The fees for export certificate from CDRH is $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

Mail : office@libertymanagement.us

http://www.fdahelp.us