Tag: US FDA Registration

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

BASICS OF IMPORTATION – MEDICAL DEVICES

FDA regulates a range of products which includes food (human and animal consumption), medical products (drugs, devices and biological products), radiation-emitting electronic products, tobacco products and cosmetics. All imported shipments of FDA regulated products are evaluated by FDA and needs to comply with same regulations as of domestic products.  The products that are offered into U.S including personal items must be declared to U.S. Customs and Border Protection (CBP). CBP will refers all FDA –regulated products to FDA for review. Mostly, importers will hire a custom broker to help them in submitting necessary entry documents and applicable payments to CBP on behalf of the importer.  FDA regulated products are refused to enter in US commerce, if they appear to be adulterated, misbranded, or restricted for Sale.   Refused products needs to be destroyed or exported from U.S within 90 days.

MEDICAL DEVICE IMPORTATION

Foreign medical device manufacturers are required to meet applicable US FDA medical device regulations in order to import devices into the U.S although the product is permitted for marketing in another country.  The following are the requirements which FDA checks at the time of importation

  1. Medical device establishment registration
  2. Device listing
  3. Medical Device Labeling
  4. Premarket Notification(510K) or Premarket approval(PMA) if applicable
  5. GMP Regulations
  6. U.S Agent for foreign manufacturers.

The Initial importer of the device are required to register their establishment with FDA.

As per FDA, an initial importer is any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.  FDA medical device establishment registration and listing can be found at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

Manufacturers, Initial importers and device user facilities are subject to Medical Device Reporting (MDR) regulation, where they have to report device-related adverse events and problems to FDA. Importers are required to maintain a MDR event file for each adverse event and also they have to forward all product complaints (MDR and non MDR events) to the manufacturer.

Medical devices that are imported into the United States must meet Custom Border Protection (CBP) requirements in addition to FDA regulations.

Liberty Management Group, a leading FDA consulting group in the United States provides assistance with medical device establishment registration, device listing, medical device label review and US agent service for foreign medical device establishment firms.

Sudha S

Regulatory Consultant

Mail: office@libertymanagement.us

http://www.fdahelp.us

BASICS OF IMPORTATION – DRUGS

FDA regulates a range of products which includes food (human and animal consumption), medical products (drugs, devices and biological products), radiation-emitting electronic products, tobacco products and cosmetics. All imported shipments of FDA regulated products are evaluated by FDA and needs to comply with same regulations as of domestic products.  The products that are offered into U.S including personal items must be declared to U.S. Customs and Border Protection (CBP). CBP will refers all FDA –regulated products to FDA for review. Mostly, importers will hire a custom broker to help them in submitting necessary entry documents and applicable payments to CBP on behalf of the importer.  FDA regulated products are refused to enter in US commerce, if they appear to be adulterated, misbranded, or restricted for Sale.   Refused products needs to be destroyed or exported from U.S within 90 days.

DRUGS IMPORTATION

FDA will verify compliance with the following requirements at the time of importation.

  1. FDA Drug Establishment Registration
  2. Drug Listing
  3. NDA or ANDA approval (If applicable)
  4. Conducts field examination and analyzes samples of drugs products to make sure they comply with standard and label requirements.
  5. FDA will make sure that the manufacturer is in not is the list of foreign manufacturers who are not in compliance with drug GMP or import alert.

FDA will verify the manufacturer’s registration and listing by comparing the submitted information to CDER’s registration and listing databases.  If the information does not match, FDA will ask for additional information or may detain the product. If the product requires a NDA, ANDA or IND and if does not have it, then FDA will subject the product to refusal.

Foreign establishments whose drugs are imported into United States are required to register with FDA and submit their drug listing information of their products intended for marketing in U.S. If the manufacturer has not registered, they need to register with FDA within 5 days after submitting their application. Also all foreign manufacturers are required to identify a U.S. Agent. FDA Drug establishment Registration and drug listing must be submitted to FDA electronically via CDER unless waiver is granted.

Drug products imported into the United States are subject to FDA labeling requirements.  FDA will review the drug labels at the time of importation to check whether they are in compliance with FDA regulations. Specific drug labeling requirements are determined by the type of drug product. OTC drugs, prescription drugs, and drugs imported for drug effectiveness studies are subject to specific labeling requirements in addition to the general drug label requirements.

Liberty Management Group , a leading FDA consulting group in the United States provides assistance with drug establishment registration, drug listing and label review and US agent service for foreign drug establishment firms.

Sudha S

Regulatory Consultant

Mail: office@libertymanagement.us

www.fdahelp.us