BLANKET LISTING SUBMISSION

The FDA (U.S. Food and Drug Administration) requires drug manufacturers to submit a “blanket listing submission” for all drug products they manufacture. This listing includes information about the drug products and the facilities where they are manufactured.

A blanket listing submission is a process by which pharmaceutical companies provide the FDA with a comprehensive list of all drug products they manufacture. This includes prescription and over-the-counter drugs.

FDA uses this information to monitor and regulate drug products in the United States. It helps the FDA track the availability and safety of drug products, as well as identify manufacturing facilities and labeler codes associated with these products.

Drug manufacturers must submit/update listing every year between October 1st and December 31st even if no changes have occurred.

The submission typically includes detailed information about each drug product, such as its proprietary name, active ingredients, dosage form, route of administration, and National Drug Code (NDC) number. It also includes details about the manufacturing facilities and labeling information.

The FDA now requires electronic submission of these listings through the FDA’s Electronic Submissions Gateway (ESG) in Structured Product Labeling (SPL) format.

Failure to submit or update these listings as required can lead to regulatory action, which includes misbranding and warning letters.

Liberty Management Group Ltd, provides assistance with drugs establishment registration, NDC labeler code request, Drug listings and US agent service to foreign facilities.

Sudha S

Regulatory Consultant

office@libertymanagement.us

www.fdahelp.us

HOMEOPATHIC DRUG REGISTRATION

Homeopathic drugs are regulated differently from conventional drugs, and the regulatory framework has been shaped by the Food, Drug, and Cosmetic Act (FD&C Act) and the Homeopathic Pharmacopoeia of the United States (HPUS).

Homeopathic drugs are subject to the provisions of the FD&C Act, which outlines the legal requirements for safety, efficacy, and labeling of drugs. The FDA recognizes the HPUS as the official compendium for homeopathic drugs in the United States. The HPUS provides standards for the preparation, quality, and labeling of homeopathic products.

Homeopathic drugs must comply with certain labeling requirements, including disclosure of ingredients, indications, and proper dilution information. However, the labeling standards for homeopathic drugs may differ from those for conventional drugs.

Liberty Management Group Ltd, provides assistance with homeopathic drugs establishment registration, drug listings and US agent service to foreign facilities.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

DRUG LISTING RENEWALS

Drug listing is an important regulatory requirement that helps the FDA track and monitor all drugs, including over the counter (OTC) drugs, prescription drugs, and other pharmaceutical products marketed in the United States. Drug listing renewals ensure that the FDA has accurate and up-to-date information about each drug product.

Here are the key points regarding FDA drug listing renewal:

  1. Annual Renewal: Drug listing information must be updated with the FDA annually. The renewal must be completed between October 1st and December 31st of each year for the following year .
  2. Electronic Submission: Drug listing renewal must be completed electronically through the FDA’s Electronic Submissions Gateway (ESG) or CDER direct.
  3. Information Updates: During the renewal process, drug manufacturers or sponsors are required to review and update the information related to their drug products, which includes information such as product formulation, labeling, manufacturer information, and establishment registration.
  4. Consequences of Non-Renewal: Failure to renew drug listings can have serious regulatory consequences. Any drug listing that is required to be certified but is not certified may be considered inactive and removed from the NDC Directory and other publications of listing data.
  5. NDC Assignment: The National Drug Code (NDC) is an essential part of drug listing. Manufacturers should ensure that the NDCs for their drug products are accurate and up to date while renewing their listings.

Liberty Management Group Ltd, provides assistance with drugs establishment registration, NDC labeler code request, Drug listing renewals and US agent service to foreign facilities.

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.

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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

OTC MONOGRAPH

An Over-the-Counter (OTC) monograph is a set of regulations established by the U.S. Food and Drug Administration (FDA) for non-prescription drugs. These monographs provide a comprehensive framework for the ingredients, labeling, and therapeutic uses of a specific category of OTC drugs. The monograph system streamlines the process for manufacturers to develop and market safe and effective OTC products without requiring approvals.

The FDA categorizes OTC drugs into various therapeutic classes (e.g., antacids, cough and cold products, pain relief, sunscreens) based on their intended use and active ingredients.

For each therapeutic class, the FDA develops a monograph that outlines the active ingredients, their permitted concentrations, labeling requirements, dosing instructions, and any other relevant specifications. The monograph serves as a standard for products within that category.

The monograph also specifies which active ingredients are generally recognized as safe and effective (GRASE) for treating specific conditions.

The monograph sets labeling requirements, with drug facts which includes use, warnings, and other information that must be included on the product’s packaging. It may also outline testing requirements to ensure product quality and consistency.

Manufacturers looking to create an OTC product within a specific therapeutic class must formulate their product according to the monograph’s specifications. If the product adheres to the monograph’s requirements, it can be marketed without requiring individual FDA approval.

The FDA periodically reviews and updates OTC monographs to reflect new scientific information, safety concerns, and changes in industry standards. Manufacturers are required to adjust their products to comply with updated monograph requirements.

In some cases where a manufacturer wishes to market an OTC product with an ingredient or use that is not covered by an existing monograph, they can pursue an OTC New Drug Application (NDA) or a New Dietary Ingredient (NDI) Notification, depending on the nature of the product.

It’s important for manufacturers to carefully follow the monograph guidelines when developing and marketing OTC drugs to ensure compliance with FDA regulations.

OTC drug manufacturers are required to comply with FDA drug regulations which includes establishment registration, drug listing, label compliance and cGMP regulations.

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.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

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

Class II: Moderate Risk

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

Class III: High Risk

  1. 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.
  2. Examples include implantable pacemakers, heart valves, and automated external defibrillators.
  3. 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

www.fdahelp.us

GUDID (GLOBAL UNIQUE DEVICE IDENTIFICATION DATABASE)

GUDID stands for the Global Unique Device Identification Database. It is a publicly accessible database maintained by the U.S. FDA. The GUDID contains information about medical devices that are labeled with a Unique Device Identifier (UDI).

The UDI system was established by the FDA to improve the identification and tracking of medical devices throughout their lifecycle, from manufacturing to distribution to patient use. The UDI consists of a unique numeric or alphanumeric code that is encoded in both human-readable form and machine-readable form (usually in a barcode or RFID tag).

Manufacturers of medical devices are required to submit information about their devices, including the UDI, to the GUDID. This information typically includes details about the device’s manufacturer, brand name, model number, expiration date, and other relevant attributes. The GUDID serves as a central repository of this information, allowing healthcare providers, regulators, and the public to access accurate and up-to-date information about medical devices.

The GUDID plays a crucial role in enhancing patient safety, facilitating device recalls, improving supply chain management, and supporting post-market surveillance of medical devices. It provides a standardized and comprehensive database that enables better traceability and identification of medical devices, contributing to the overall quality and safety of healthcare.

Liberty Management Group, a leading FDA consulting group in the United States, provides assistance with UDI account creation, selection of Accrediting agency, GUDID submission.

Sudha S

Regulatory Consultant

Office@libertymanagement.us

www.fdahelp.us

CERTIFICATE TO PHARMACEUTICAL PRODUCT (CPP)

A Certificate of Pharmaceutical Product (CPP) is an internationally recognized document that confirms the marketing status and regulatory compliance of a pharmaceutical product. FDA is issuing it to facilitate export of FDA-regulated products from the United States.

The CPP provides information about the product, such as the product name, dosage form, strength, manufacturer, and the regulatory status in the country of origin. It serves as evidence that the product is authorized for sale in the country of origin and meets the regulatory requirements for quality, safety, and efficacy.

Foreign governments are seeking official assurance that products exported from the United States to their countries can be marketed in the United States or meet specific U.S. regulations, such as current good manufacturing practice (CGMP) regulations. A foreign government may also require export certification as part of the process register or import a product into that country.

To obtain a CPP, the pharmaceutical manufacturer must apply to FDA where the product is authorized for sale. The application must include information about the product, its regulatory status, and the intended recipient country. FDA will review the application and issue the CPP if the product is deemed to follow their regulations.

It is important to note that the requirements for obtaining a CPP may vary between countries and regions. Some countries may require additional documentation or information, while others may not recognize the CPP at all.

Requirements to get the Certificate to Pharmaceutical Product (CPP)

  1. The manufacturing facility must have a valid drug establishment registration.
  2. All drugs must be listed with FDA.
  3. The drugs should meet all the drug labelling requirements as per 21 CFR 201.
  4. The drugs should be manufactured in accordance with 21CFR 210 also known as Good Manufacturing practice.

Liberty Management Group, a leading FDA consulting firm provides assistance with FDA drug establishment registration, drug listing and certificate to Pharmaceutical Product.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.us

PRIVATE LABEL DISTRIBUTOR

A firm that does not participate in the manufacture or processing of a drug but markets and distributes under its own trade/brand name, and labels a drug product made by someone else, is referred to as a Private Label Distributor or PLD.

The private label distributor takes on the responsibility of marketing, branding, and selling the products, while the manufacturer is responsible for producing and supplying the products.

PLDs do not have a registration or listing obligation for drugs since they do not manufacture or process in their facility.

They may elect to submit listing information for a drug they do not manufacture or process directly to the FDA by themselves or if they do not want to list, the manufacturer must submit the drug listings on behalf of the private label distributor.

If the PLD submit the listings under their NDC number, they assume full responsibility for compliance with all listing requirements.

To be a successful private label distributor, it is important to have strong relationships with manufacturers, a clear understanding of market trends and consumer preferences, and effective branding and marketing strategies.

The steps involved in drug listings can be checked at https://www.fdahelp.us/otc-drug-registration-process-fda.html

Liberty Management Group Ltd, provides assistance with drugs establishment registration, NDC labeler code request, Drug listings and US agent service to foreign facilities.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

UDI REQUIREMENT FOR CLASS I MEDICAL DEVICES

The Unique Device Identification (UDI) system is a globally recognized system for identifying and tracking medical devices throughout their distribution and use. It was established by the US Food and Drug Administration (FDA) to enhance patient safety and improve the efficiency of medical device recalls.

For class 1 medical devices, which are considered low risk devices, the UDI requirements are more flexible than for higher risk devices. Class 1 devices are exempt from the requirement to include a UDI on the device label if they are exempt from GMP regulations.

FDA has categorized Class 1 devices in two categories.

  1. Class 1 devices that are considered as consumer health products.
  2. Class 1 devices that are not considered as consumer health products.

Class 1 devices that are considered as consumer health products are the devices that pose the lowest risk of which many are 510(k)-exempt devices are sold directly to consumers over-the-counter in retail and online stores. Since these devices pose the lowest risk, FDA does not intend to enforce GUDID submission requirements under consumer health products.

Class 1 devices that are not considered as consumer health products are the devices that are typically used in healthcare settings and are often subject to additional regulatory controls, such as 510k submission. Submission of UDI for these devices will be helpful in reducing medical errors and simplify the integration of device use information into data systems.

Below are the compliance dates for class I medical devices.

Device Type Compliance Date
Class I and unclassified devices, other than I/LS/LS devices, that are required to bear a UDI September 24, 2022
Class I and unclassified devices, other than I/LS/LS devices September 24, 2022
Class I and unclassified devices, other than I/LS/LS devices, that are required to bear a UDI December 8, 2022

The UDI for class 1 medical devices must be in a human-readable format and a machine-readable format, such as a barcode or RFID tag. The UDI must also be submitted to the FDA’s Global Unique Device Identification Database (GUDID), which is a publicly accessible database that contains information on medical devices.

The UDI system helps to ensure the safety and effectiveness of medical devices by enabling more accurate tracking and monitoring of these products throughout their lifecycle.

Liberty Management Group, a leading FDA consulting group in the United States, provides assistance with UDI account creation, selection of Accrediting agency, GUDID submission.

Sudha S

Regulatory Consultant

WWW.fdahelp.us

Email: Office@libertymanagement.us