fda registration medical device – Page 2

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

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

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

MEDICAL DEVICE REPORTING (MDR)

Every year FDA receives thousands of reports of deaths associated with medical devices, serious injuries and device faults. Medical Device Reporting (MDR) is one of the monitoring tool that FDA uses to check the device performance, to find device –related safety issues and contribute to risk and benefit assessment of medical devices.

Who needs to report?

Manufacturers: Manufacturers are required to report to FDA when they find any of their devices may have caused or contributed to a death or serious injury and device malfunction. They must also report if there is any death or serious injury if the malfunction were to recur.

Importers: Importers are required to report to FDA and the manufacturer as soon as they find out that one of their devices may have caused to contribute to a death or serious injury. However the importer must report only to the manufacturer if their imported devices have malfunctioned and would likely to cause death or serious injury if the malfunction were to recur.

Device User Facilities: A “device user facility” is a hospital, nursing home, ambulatory surgical facility, outpatient diagnostic or treatment facility (not a physician’s office). User facilities are required to report to both FDA and the manufacturer. If the manufacturer is unknown, user facilities are required to report only to FDA if there is any medical device related injury or death. User facilities are not required to report any device malfunction but can voluntarily report to FDA by using MedWatch through Electronic Medical Device Reporting (eMDR)

Voluntary Medical Device Reporting: FDA urges healthcare professionals, patients, caregivers and consumers to submit voluntary reports if there is any significant adverse events or device malfunction through MedWatch program.

Liberty Management Group Ltd, is a leading US FDA consulting group provides assistance with food, drug, medical device and cosmetic registration and US Agent service to foreign facilities.

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

NATIONAL DRUG CODE (NDC) – AN OVERVIEW

According to the Drug listing act of 1972, all registered drug establishments must provide the current list of all drugs manufactured, processed, prepared, propagated, compounded or processed for commercial distribution in their facility to FDA. These drugs products are identified and reported by using a unique three segment number called National Drug Code (NDC), which serves as universal product identifier for human drugs.

NDC number is a unique 10-digit, 3–segment numeric identifier assigned to each drug listed under Section 510 of FD&C act. Each NDC number identifies the labeler, product and the trade package size of the drug.

The first segment of NDC is known as labeler code, which is a unique 5 digit number assigned by FDA to each establishment that manufactures (including contract manufacturers, re-packers or re-labelers) or distributes (under its own name- Private label distributor).
Second segment, which is the product code, identifies the specifications (strength, dosage form and formulation) of a drug for a particular manufacturer. This denotes that different formulations or different strengths of the same formulation should be assigned different product codes.
The third segment, the package code, classifies package sizes and types. The second and third segments of NDC should be assigned by the labeler. The NDC will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1.

NDC Labeler code request to FDA should be submitted in SPL (structured Product Labeling) format via FDA ESG (electronic submission gateway). Labeler is responsible for each NDC directory entry submitted through SPL files. Entry in NDC directory doesn’t indicate that FDA approved or verified the information of the drug. Assignment of NDC number to non-drug products is strictly prohibited. Under FD&C act, registration of a drug establishment or assignment of NDC number does not denote that FDA’s approval of the company or its products.

Even though NDC number is a mandatory requirement, but it is not required to appear on all drug labels and including the label of any prescription drug carton given to a consumer. However, if the same drug product that are sold or used in the hospitals are required to put bar code on their products.

NDC Directory does not include animal drugs, blood products, API (Active Pharmaceutical Ingredients), drugs manufactured exclusively for a PLD, or drugs that are marketed as a part of a kit or combination product or inner cover of a multi-level packaged product not marketed separately.

Liberty Management Group Ltd, provides assistance with drugs establishment registration , NDC labeler code request, Drug Listing and US agent service to foreign facilities.

Sudha S

Regulatory Consultant

Mail: office@libertymanagement.us

http://www.fdahelp.us

CERTIFICATE TO FOREIGN GOVERNMENT (CFG)

Certificate to Foreign Government (CFG) is document prepared by FDA issued for legally marketed devices in the U.S that are in compliance with the regulations of FD&C act.

Medical devices that are legally marketed in the United States can be exported to anywhere in the world without getting approval from FDA. Although FDA does not restrict the export of legally marketed, certain importing countries require a certification from FDA stating that the firm, or its devices are in compliance with U.S. FDA regulations. Foreign government will ask for official assurance that the products exported to their countries are in compliance with US FDA regulations such Good manufacturing Practice (GMP) requirements. In that cases, U.S companies can request a certificate to foreign government (CFG) also known as Certificate of Free sale to FDA.

The certificate to foreign government (CFG) is a self-certification process. By completing the required form, a firm confirms that it is registered with FDA and listed their device with FDA, that each product is legally marketed in the U.S. and is not the subject of an open recall, that all facilities involved in the manufacturing process are complying with the FDA’s regulations, and that each product is being exported from the U.S.

Requirements to get the Certificate to Foreign Government (CFG)

The manufacturing facility must have a valid medical device establishment registration
All devices must be listed with FDA
The devices must have cleared Premarket notification (510K) or Premarket Approval (PMA) unless it is exempted by the regulation.
The device should meet all the medical device labelling requirements as of 21 CFR 801 and 809.
The device should be manufactured in accordance with 21CFR 820 also known as Good Manufacturing practice unless it is exempted by the regulation.

Certificate to Foreign government can be requested through CECATS system. It is a voluntary electronic system that allows the manufacturers and initial importers to request export documents online. CECATS can be accessed by logging into FDA Furls account.

The fees for export certificate from CDRH is $175 for the first certificate and $85 each for additional certificate upon the request from the customer.

Liberty Management Group, a leading FDA consulting firm provides assistance with FDA Medical device registration, device listing and certificate to foreign government application.

Sudha S

Regulatory Consultant

Mail : office@libertymanagement.us

http://www.fdahelp.us

UNIQUE DEVICE IDENTIFICATION (UDI)

FDA has released a final rule under which all medical devices will be marked with a Unique Device Identifier (UDI) that will appear on the label and package of a device which is used to identify the devices through their distribution and usage of it. UDIs should be on the device labels in both a human-readable format and a machine-readable format (e.g., a barcode) unless the rule provides for an exception or alternative. The UDI should be marked directly on the devices that are intended for more than one use and has to be reprocessed before each use.

A UDI consists two parts, Device Identifier (DI) and Product Identifier (PI), where

Device Identifier (DI) is a mandatory, fixed portion of a UDI which identifies the specific version or model of a device and its labeler. Labeler has to apply for New DI if there is any change in version or model of the device.

Product Identifier (PI) which is a conditional and variable portion of a UDI is required to identify the lot or batch number of a specific device , serial number, expiration date, date of manufacture and the distinct identification code(If applicable). PI will change for each lot or batch.

FDA has accredited the following agencies in assignment of UDIs according to the UDI regulations.

GSI – http://www.gs1.org /
Health Industry Business Communications Council (HIBCC) – http://www.hibcc.org /
International Council for Commonality in Blood Banking Automation (ICCBBA – http://www.iccbba.org

Each issuing agency has a unique device identifier (UDI) format that was assessed and approved by FDA as part of its process for accrediting issuing agencies. Any changes to the format of the UDI by an issuing agency must be approved by FDA before implementation.

Device labelers are required to submit information about each device to FDA’s Global Unique Device Identification Database (GUDID), where the public can search and download information from GUDID at AccessGUDID. GUDID has a standard set of basic elements for each device with a UDI, which contains only DI that helps to get the device information in the database. Product Identifiers (PI) are not part of GUDID

Compliance Dates issued by FDA in conjunction with UDI Final Rule are

Class III medical devices which includes stand –alone software – September 24, 2014
Implantable, life supporting and life sustaining devices which includes stand-along software – September 24, 2015
Class III reusable devices that are required to have UDI on the device itself, Class II devices – September 24, 2016
Class II reusable devices that are required to have UDI on the device itself, Class I which includes stand-alone software and Unclassified devices – September 24, 2018
Class I reusable devices that are required to have UDI on the device itself – September 24, 2020
For Class I and unclassified devices manufactured and labeled on or after September 24, 2018 – September 24, 2022
For Finished Class I and unclassified devices manufactured and labeled before September 24, 2018 – September 24 , 2022

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

Mail : office@libertymanagement.us

www.fdahelp.us

PREMARKET NOTIFICATION 510(K)

A 510(k) or Premarket Notification is the technical document required by the FDA to prove that the device to be marketed in the United States are as safe and effective, that is, substantially equivalent, to a legally marketed device which is not subject to PMA. A person who apply for 510K clearance must compare their device to similar legally marketed devices and create and support their substantial equivalence claims. The legally marketed devices to which uniformity is drawn is known as “Predicate”.

The Submitter cannot market the device until he receives an order from FDA declaring a device substantially equivalent (SE). Once the device is declared as SE, it can be legally marketed in United States. SE determination will be made within 90 days of submission and also based on the information submitted by the submitter. Substantial equivalence is issued with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics of the device. If FDA found out that the device is not substantially equivalent (SE), the submitter has to resubmit another 510K with new information or request a product classification via De Nova Classification process or to submit a premarket approval application (PMA).

Who needs to submit a 510K

The following are the four categories of 510K submitters to the FDA.

Domestic manufacturers who introduce a new device to the U.S market. However only finished device manufacturers who manufacture device according to their own specifications needs to submit 510K, whereas the contract manufacturers are not required to submit a 510K.
Specification developers are required to submit a 510K but not the contract manufacturers.
Re-packers or Re-labelers may be required to submit 510K if they change the labels or any other operations that affect the condition of the device.
Foreign manufacturers/exporters who introduce a new device to the U.S market.

All manufacturers, specification developers of Class II and Class III devices and certain Class I devices are required to follow 21 CFR 820 regulations.

Liberty Management Group, a leading FDA consulting group in the United States, provides assistance with preparation and submission of 510K to FDA, US agent service for foreign facilities, medical device establishment registration and listing with FDA.

Sudha S

Regulatory Consultant

Mial : office@libertymanagement.us