FDA Medical device registration – Page 2

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

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

www.fdahelp.us

MEDICAL DEVICES – WHO NEEDS TO REGISTER?

Establishments that are involved in the manufacturing and distribution of medical devices that are used in commercial distribution in the United States which includes import for export only devices are required to register with FDA annually.

As per 21 CFR Part 807, most establishments that are registered with FDA are also required to list the devices with FDA.

Below are the list of requirements for registration and listing depending on the type of activity conducted in the establishment.

Manufacturer: Establishments engaged in manufacture, preparation, propagation, compounding, and assembly or processing of a medical device intended for commercial market in the United States are required to register, list and pay FDA fees. This also includes the manufacturers of accessories that are packed or labeled for commercial distribution for health related issues to an end user, kit assemblers and also manufacturers of custom device and U.S establishment that manufactures for export only.

Contract Manufacturer: Manufactures a finished device as per other establishment’s specification are called as contract manufacturer. Since contract manufacturer meets the definition of finished device manufacturer they are also required to register, list and pay FDA fees.

Specification Developer: Specification developerare the ones who creates the specification for a device which are marketed under the establishment’s name but do not manufacture the device. In addition to that, they also arrange for the manufacturing of devices labeled with another establishment’s name by a contract manufacturer. Specification developers are required to register, list with FDA and pay the fees.

Contract Sterilizer: Establishments that provide sterilization service for another establishment’s device are required to register, list with FDA and pay the fees.

Re-processor of Single Use Device: Establishments that remanufacture single use device are required to register, list with FDA.

Re-packager or Re-labeler: Establishments that packages finished devices from bulk or re-package devices manufactured into different containers are required to register and list with FDA. Also establishments that changes the content of the labeling from the original manufacturer for distribution under establishment’s own name.

Remanufacturer: Any person or a firm who processes, refurbishes, conditions, repackages or does any other operation to a finished device that considerably changes the finished device’s performance are required to register, list with FDA.

Foreign Exporter: Establishments in a foreign country that exports finished device to United States for commercial distribution are also required to register and list their devices with FDA.

Initial Importer: Any establishment with a physical address in the United States which furthers the marketing of a medical device from a foreign manufacturer, who make the final delivery to the end user, but does not repackage or relabel or change the device package are required to register with FDA and also needs to identify the foreign manufacturer.

All companies that register with FDA are required to renew their registration and pay FDA fees for the following Fiscal year between Oct 1^st and Dec 31^st every year to keep their registration active.

Liberty Management Group Ltd, is a leading FDA consultant provides assistance with FDA registration, medical device listing and registration renewal and U.S agent service for foreign facilities.

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

Medical device establishment registration
Device listing
Medical Device Labeling
Premarket Notification(510K) or Premarket approval(PMA) if applicable
GMP Regulations
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