FDA Medical Device Labeling

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

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

DRUG LABELING

Drug label is a printed information which is included with any OTC drugs, prescription drugs or any dietary supplements. Drugs labels are regulated by FDA and provide information to healthcare providers and patients on safe and effective use of the product. The information on the labels must be accurate and should not be misleading

All drugs or drug products in finished package form is considered as misbranded if it does not comply with FDA labeling requirements. The labels needs to have the name and place of business of the manufacturer, packer or distributor.

All registered drug establishments which includes API manufacturer, bulk manufacturer, contract manufacturer, repackers, relabelers are required to list their products under their own labeler code, however NDC number is not required to appear on all drug labels, including the label of any prescription drugs given to a customer.

Drugs labels should contain all drug facts which includes active ingredients, purpose and uses of the drug, directions, other information, inactive ingredients, phone numbers if there is any questions or comments.

When there is an expiration date on the drug products, it should appear on the container and also in outer package. However, if it is a single dose drug product packed in individual cartons, the expiry date should be on the individual carton not on the product container.

Manufacturers, Contract manufacturers, repackers, relabelers, and private label distributors of a human prescription drugs or an over-the-counter (OTC) drugs that is regulated under the FD&C act are not required to have bar code on the products. However, if the same drug product that are sold or used in the hospitals are required to put bar code on their products.

Liberty Management Group provides assistance with drug establishment registration, drug listing and label review.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us