Author: Sudha S

SUNSCREEN REGISTRATION

Sunscreen products are regulated by the FDA as over the counter (OTC) drugs. So, manufacturers must comply with drug regulations and guidelines to ensure their products are safe and effective for consumers.

Steps involved in Sunscreen registration are

  1. Monograph Compliance:
    • Sunscreens products must comply with the FDA’s OTC sunscreen monograph, which outlines the active ingredients, labeling, and testing requirements.
    • The current FDA-approved active ingredients for sunscreens include substances like zinc oxide, titanium dioxide, avobenzone, and others.
    • Products that adhere to OTC monograph do not require FDA pre-approval but must follow all regulations.
  2. Establishment Registration:
    • Manufacturers, packers, or distributors of sunscreen products must register their establishment with the FDA.
  3. Product Listing:
    • Once establishment is registered, the manufacturer must list the sunscreen products with the FDA with NDC number.
    • Drug listing includes all the active and inactive ingredients, drug facts label along with labels.
  4. Labeling Requirements:
    • Sunscreens must be labeled according to FDA regulations. This includes information on SPF water resistance, and appropriate usage directions.
    • Warnings and directions must be included to ensure proper use of the product and to minimize risks.
  5. Good Manufacturing Practices (GMPs):
    • Sunscreen products must be manufactured in compliance with Good Manufacturing Practices (GMPs) to ensure product quality and safety.
  6. Testing Requirements:
    • Sunscreens must undergo specific testing to substantiate their SPF claims and water resistance. The results of these tests must be documented and available for FDA review in case of inspection.
  7. Adverse Event Reporting:
    • Manufacturers must report any adverse events related to their sunscreen products to the FDA. This helps the FDA monitor the safety of sunscreens on the market.

Liberty Management Group , as a leading FDA consultant with provide assistance with drug establishment registration, drug listing and label review.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

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

HAND SANITIZER REGULATION

The FDA (Food and Drug Administration) regulates hand sanitizers to ensure they are safe and effective for consumer use even though it is considered as cosmetics in some foreign countries.

The FDA recognizes ethanol or ethyl alcohol (60% to 95 %) and isopropyl alcohol (70% to 91.3 %) as safe and effective to be used as an active ingredient in hand sanitizers. Benzalkonium chloride is another active ingredient considered safe and effective, though less effective than alcohol-based sanitizers against certain germs.

FDA consider hand sanitizers as OTC drugs and must comply with below requirements.

  • Submit drug listing with unique 10-digit NDC number for each hand sanitizer after FDA assign labeler code to the company.
  • Label Compliance – Antiseptic hand sanitizer must have “Drug Facts” labeling and all other required information like usage, directions, and warnings.
  • Comply with GMP Requirements as per 21 CFR 211 – Hand Sanitizer GMP which requires testing to ensure that the products are free from contamination and impurities.

Manufacturers that continue to make hand sanitizer products as of December 31, 2024, will be identified as OTC monograph drug facilities and be subject to an OMUFA facility fee for FY 2025 whereas if a company stopped the manufacturing process of hand sanitizers and deregister and de-lists their products before December 31st ,2024 will not be subject to FY 2025 OMUFA fee.

Liberty Management Group provides assistance with drug establishment registration, drug listing and label review and US agent service to foreign drug companies.

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:

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

DRUG DE-LISTINGS

The FDA (Food and Drug Administration) in the United States is responsible for regulating pharmaceuticals, including the approval and potential delisting (withdrawal) of drugs from the market. Drugs can be delisted for several reasons, including safety concerns, lack of efficacy, or when manufacturers fail to comply with regulatory requirements.

If a company no longer markets the drugs for several reasons, then they must de-list it with marketing end date which is the expiration date of last lot manufactured.

All drug listings must be renewed between October 1st and December 31st every year.

Starting January 1st every year FDA will inactivate human drug listings that are not certified between the renewal period of October 1 to December 31.

In addition to that starting from July 1st every year, FDA will begin to inactivate human drug listings that remain active and certified after the June listing update, if it contains at least one establishment that is not currently registered.

A private label distributor (PLD) or finished drug manufacturer can certify the drug listing at any time during that window, including prior to the renewal of the registration of an underlying manufacturer.

Prior to the listing renewal, manufacturers must renew their registration between October 1st and December 31st each year.

If the manufacturer fails to renew their registration, the listings will be considered misbranded for being manufactured at an unregistered establishment.

In July, the FDA will inactivate those active listings which are still linked to an unregistered establishment.

FDA will send Prior notification to the labeler code contacts for any listing in jeopardy of being inactivated, to allow for an update.

FDA inactivation is not the same as de-listing of the drug.  As per FDA regulations, companies must de-list the products when they discontinue manufacturing it for commercial distribution.

Liberty Management Group provides assistance with drug establishment registration, drug listing and drug listing renewals, and de-listings.

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

SELF-IDENTIFICATION

The FDA Self-Identification applies to facilities and organizations involved in the development and manufacturing of generic drugs.

Facilities that manufacture or intend to manufacture must submit Self-Identification.

  • Active Pharmaceutical Ingredients (API) of human generic drugs.
  • Finished Dosage Forms (FDF) of human generic drugs.
  • Sites and organizations involved in:
  • Bioequivalence (BE)/bioavailability (BA) sites that are registered as a generic drug submission and conduct clinical BE/BA testing, bioanalytical testing of samples collected from clinical BE/BA testing, and/or in vitro BE testing)
  • Testing, repackaging, or relabeling of generic drugs (exempt from user fees)

Self-Identification must be submitted via CDER Direct or ESG portal by generating SPL files.

Under GDUFA, if a facility fails to self-identify, all FDF or API products manufactured at the facility and all FDFs containing APIs manufactured at the facility will be deemed misbranded.  It is a violation of federal law to ship misbranded products in interstate commerce or to import them into the United States. Such violations can result in prosecution of those responsible, injunctions, or seizures of misbranded products. Products are considered as misbranded because of failure of the facility to self-identify are subject to being denied entry into the United States.

Self-identification must be submitted between May 1 and June 1 of each year.

Liberty Management Group LTD, as a leading FDA consulting firm provides assistance with SPL preparation and submission of Self-Identification to FDA.

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 1st and December 31st 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

DRUG LISTING

All domestic or foreign establishments that manufactures or commercially distributes human drug and animal products within the U.S., you are subject to drug establishment registration and drug listing requirements. Establishment Registration and drug listings lets FDA to develop and maintain a catalog of all drug products marketed in the U.S. Registration information provides the locations and contact information for drug establishments and determines sites for inspection. Drug product listing information provides an inventory of all drug products in the market with manufacturing information, which includes inactive ingredients incorporated into marketed drug products. The FDA depends on this registration and listing information for controlling key programs, including post-marketing surveillance; user fee assessments; counterterrorism; monitoring of drug shortages and availability; and determining products that are being marketed without an approved application. The electronic drug establishment registration and drug listing system (eDRLS) also populates electronic listing databases such as DailyMed and the National Drug Code (NDC) Directory, improving the accuracy and inclusiveness of these databases.

Drug establishments (manufacturers/contract manufacturers, re-packagers, re-labelers) – domestic and foreign – must register with the US FDA and list their products.

There is no registration requirement for Private Label distributors, but they must list their products under their own NDC number.

Listing can be done electronically via ESG portal or FDA’s CDER direct.

Listings must be updated every June and December, or sooner if there are any changes. There is also an annual renewal period (October 1 to December 31) for certification which is called No-change certification (Blanket listing submission)

Liberty Management Group provides assistance with drug establishment registration, drug listing and label review and US agent service to foreign drug companies.

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