Month: August 2023

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