Month: August 2019

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 1st and Dec 31st 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