FDA News – Page 4 – by Liberty Management Group Ltd.

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

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

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

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)

The manufacturing facility must have a valid drug establishment registration.
All drugs must be listed with FDA.
The drugs should meet all the drug labelling requirements as per 21 CFR 201.
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.

Class 1 devices that are considered as consumer health products.
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

DRUG REPORTING

To address drug shortages, the FDA has issued a new guidance on drug reporting under which drug establishments are required to submit reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by section 510(j)(3) of FD&C act.

As per the guidance, drug manufacturers are required to submit a list of all drugs they manufacture, prepare, propagate, compound, or process for commercial distribution annually. This list must include the name and National Drug Code (NDC) of each drug, as well as other information such as the dosage form, strength, route of administration, and package size.

The FDA uses this information to maintain a comprehensive database of all marketed drugs in the United States. This database is known as the National Drug Code Directory and is used by healthcare providers, pharmacists, and others to identify and track drugs in the supply chain.

FDA requires all drug manufacturers which includes prescription drugs, over the counter (OTC) drugs, and biologic products , re-packers and re-labelers, active pharmaceutical ingredient (API), and other types of listed drugs, medical gases, homeopathic products, animal drug products, and distributors to submit drug reporting to the agency.

For private label distributors, the data should be submitted separately by the NDC associated with the registrant’s labeler code and the NDC associated with the private label distributor’s labeler code.

Reports on the amount of each registrant’s listed drugs must be submitted yearly. Such reports should include information regarding the amount of drug released for the respective calendar year (January 1 – December 31) and should be submitted no later than February 15 of the following fiscal year.

Liberty Management Group, as a leading FDA consulting firm, can help you in submitting the drug reports to FDA on time.

Sudha S

Regulatory Consultant

Mail: Office@libertymanagment.us

www.fdahelp.us

OVER-THE-COUNTER MONOGRAPH DRUG USER FEE PROGRAM (OMUFA)

As per CARES Act, over-the counter (OTC) drugs otherwise known as OTC monograph drugs, can be marketed without an approved drug application if they meet the other applicable requirements. Under this OTC monograph reform legislation, FDA is entitled to assess and collect user fees dedicated to OTC monograph drug activities.

FDA states that OMUFA fee will fund a portion of their regulatory activities for OTC monograph drugs and its performance goals, which includes reviewing of new submissions within specific time frames and inspections.

On March 16^th, 2022, FDA announced the OMUFA for FY 2022.

As per FD&C Act, a facility fee for FY 2022 will be calculated based on the facility that is identified as an OTC monograph drug facility during the fee-liable period from January 1, 2021, through December 31, 2021.

FDA will calculate and collect facility fees with respect to the two types of OTC monograph drug facilities—MDF and CMO facilities. Facility fees will be calculated to each qualifying person that owns a facility identified as an MDF and a reduced facility fee (two- thirds) will be assessed to each qualifying person that owns a facility identified as a CMO facility. FY 2022 facility fees are due on June 1, 2022.

OTC monograph drug facility (MDF) is a foreign or domestic establishment that is engaged in manufacturing or processing the finished dosage form of an OTC monograph drug.

A contract manufacturing organization (CMO) facility is an OTC monograph drug facility where neither the owner nor any affiliated partner or the establishment sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States.

FDA Fees for OTC Monograph Drug Facility Registration for Fiscal Year 2022

Type of Registration / Application	MDF Facility	CMO Facility
OTC Monograph Drug Facility Fee	$24,178	$16,119

FDA also stated that manufacturers that entered the over-the-counter industry to Supply Hand Sanitizers during the COVID-19 Public Health Emergency are not subject to the Over-the-Counter Drug Monograph Facility Fee (OMUFA) fee.

Below are the facilities exempted from OMUFA.

API Manufacturers.
Clinical Research Supply manufacturers
Testing establishment.
Facilities placing outer packaging on already packaged products containing various products like creating multiple packaging.
Animal drug manufacturers.
Homeopathic drug manufacturers

Liberty Management Group Ltd, a leading FDA consulting group provides assistance with OMUFA PIN creation, API drug establishment registration, Drug establishment registration and listing renewals and US agent service to foreign countries.Homeopathic drug manufacturers

Sudha S

Regulatory Consultant

Mail: Office@libertymanagment.us

https://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 1^st and December 31^st 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 1^st and December 31^st. 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