REgulatory STRATEGY

The startup and small business compliance arena can be a new and fierce frontier that requires a solid understanding of the FDA regulatory process. O'Connell & Myers has the experience to help guide your company in the right direction to develop the right regulatory strategy for your company. Having a solid strategy early in the design process will save you time and money. We will work with your development team to understand your device and the direction you are headed to build a regulatory strategy that not only will get your device to market today.

labeling development & review

In today's regulatory climate, labeling is a very visible reflection of your compliance status. The information contained on your labeling and marketing literature needs to be accurate and must be supported by data. Does your device need an Instructions For Use? Does your barcode comply with Unique Device Identifier regulations. Is a prescription symbol necessary?

These are all tough questions that O'Connell & Myers can help you answer.  

U.S. Agent & Official Correspondent

All foreign device manufacturers must identify a U.S. Agent & an Official Correspondent. This person has to reside in the U.S. and is responsible for assisting the FDA with any communications between the Agency and the foreign firm, such as responding to question or setting up an inspection.

If you are an international firm and want to get your device to market in the U.S. let O'Connell & Myers be you U.S. Agent and Official Correspondent.

FDA Submissions

The FDA requires certain levels of documentation depending on the risk classification of your device. The FDA no longer accepts paper-based submissions so you have to submit using the eSTAR template. Is your Customer Collaboration Portal set up? Let O'Connell & Myers help you develop your submission eSTAR package so you can get the FDA review process started.

Device listing

When should our company list our device? Do we list before we distribute? How often do we have to update the listing? O'Connell & Myers can help you navigate this complex system.

supplier assessment

The FDA requires that a company maintains control over every part of device development and production, including sourcing the components and outside services. Are all of your suppliers ranked by criticality and on the Approved Suppliers List? Do you have an agreement with your suppliers that defines who is responsible for what? Let O'Connell & Myers develop a supplier assessment program that you can implement so you will be able to have confidence in your supplied raw materials and components.

Establishment REgistration

What is establishment registration? Does my company need to register or list? When does my company need to register? What does it cost? Do foreign manufacturers need to register? Who is our Official Correspondent? Don't worry, O'Connell & Myers can advise and prepare you for registering with the FDA.  

Design changes & Sustainability

Now that your device is on the market, what do you do when you need to make a change to the device design? What if you want to change critical suppliers? Do you need to notify the FDA? Do you need a new submission? These are all real questions that have very serious implications. Let O'Connell & Myers work with you to determine the appropriate course of action to keep your device on the market.

UDI / GUDID

A Unique Device Identifier is a requirement for most all medical devices. Does your device require a UDI? What about a production identifier (PI)? Do you have a Global Unique Device Identifier Database set up with the FDA? Set up a call with O’Connell & Myers so we can help you get your device compliant with the UDI/GUDID regulations.