After obtaining market clearance/approval for your device you still need to comply with US postmarket requirements. The following are just a few of the requirements you must follow:

ESTABLISHMENT REGISTRATION

Establishments involved in the production and distribution of medical devices intended for marketing or leasing (commercial distribution) in the United States are required to register with the FDA. This process is known as establishment registration. Registration provides FDA with the location of medical device manufacturing facilities and importers.

We can help you with your registration using FDA FURLS electronic submission system.

MEDICAL DEVICE LISTING

Most medical device establishments required to register with FDA must also identify to FDA the devices they have in commercial distribution including devices produced exclusively for export. This process is known as medical device listing and is a means of keeping FDA advised of the generic category(s) of devices an establishment is manufacturing or marketing.

Push-Med can assist you with the listing of your device(s) and help you keep your records up-to-date.

MEDICAL DEVICE REPORTING

Medical Device Reporting regulations require firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incidents.

We can help you develop and implement SOPs that will assist your company with the reporting process if such need arises.

US AGENT SERVICES

FDA requires all medical device companies without a location in the United States to appoint a registered US FDA Agent. An appointed US FDA Agent must be a resident of the United States OR maintain a place of business in the US. The responsibilities of the United States agent include assisting FDA in communications with the foreign establishment; responding to questions concerning the foreign establishment's products that are imported or offered for import into the United States; and assisting FDA in scheduling inspections of the foreign establishment.

Push-Med will act as a liaison between your company and FDA, answer questions concerning your products and assist you and FDA with scheduling inspections. We will ensure that your interests are handled professionally, confidentially and promptly.