FDA Registration For Medical Devices

Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. Primary Solutions are able to assist you in Registering your facility with FDA and List your medical devices. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also submit the FDA premarket submission number (510(k), PMA, PDP, HDE).

Medical devices are required to be cleared by the U.S. FDA before they can be sold in the United States. To obtain such clearance, companies must file an application and exhibits to demonstrate that the device is substantially equivalent to a device already legally marketed in the U.S., including substantial scientific and technical information. A 510k is a premarket submission made to FDA to demonstrate that the device to be marketed is safe and effective. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims. Most companies have the technical expertise to compile their scientific information for a 510(k) submission. However, many companies need assistance with the structure, format and verification, to ensure that all required elements are included in their 510(k) prior to submission.

Our services include:

• Identification of device class, product code and regulation number

• Identification of predicate device

• Identification of 510k test requirements

• Identification testing lab

   

• Preparation of 510k documents

• Submission of 510k document to FDA

• Communicate to FDA on behalf of our client

• Prepare clarifications to questions from FDA

• Assistance in transfer of 510k review fees to FDA

• Assistance in Establishment registration with FDA

• Assistance in Device Listing with FDA *make similar diagram http://www.fdahelp.us/Pdf/510k.pdf

The Medical devices marketed in the United States, whether they are manufactured here or are imported from abroad, must comply with the FDA labelling requirements, if the labelling of a medical device is not in compliance with FDA regulations or requirements it will be considered as misbranded. Primary Solutions can advise and ensure that your labelling is in compliance with FDA regulations. “labelling” is defined by the U.S. Federal Food, Drug and Cosmetic Act (FFDCA) as all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article. The term ‘accompanying’ is interpreted liberally to mean more than physical association with the food product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instructions, websites, etc.

The Medical devices marketed in the United States, whether they are manufactured here or are imported from abroad, must comply with the FDA labelling requirements, if the labelling of a medical device is not in compliance with FDA regulations or requirements it will be considered as misbranded. Primary Solutions can advise and ensure that your labelling is in compliance with FDA regulations. “labelling” is defined by the U.S. Federal Food, Drug and Cosmetic Act (FFDCA) as all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article. The term ‘accompanying’ is interpreted liberally to mean more than physical association with the food product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instructions, websites, etc. Agent Services –make this title clickable, when they click show the below content Any foreign medical device establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a medical device imported into the United States must engage a U.S FDA Agent for that establishment. Information about a foreign establishment’s U.S FDA Agent is submitted electronically using the FURLS system and is part of the establishment registration process. Each foreign establishment may designate only one FDA Agent. The foreign establishment may also designate its U.S FDA Agent as its official correspondent. The U.S FDA Agent has no responsibility to report adverse events under the Medical Device Reporting regulation.

The responsibilities of the US FDA Agent are limited and include:

Assisting FDA in communications with the foreign establishment:

• Responding to questions concerning the foreign establishment’s devices that are imported or offered for import into the U.S

• Assisting FDA in scheduling inspections of the foreign establishment

• If FDA is unable to contact the foreign establishment directly, FDA may provide information or documents to the U.S FDA Agent

As your U.S. FDA Agent, Primary Solutions PLT is able to assist you in:

• Establishment Registration

• Medical Device Listing

• FDA 510 K Submission

• Official correspondent requirements

• Providing consultation on medical device labelling compliance with FDA regulations.