FDA

Marketing a medical device in the US means interacting with the Center for Devices and Radiological Health of the FDA. If your company is not located in the US, a US Agent who is physically present in the United States must be designated as a go-between.

Preparation and submission of 510(k) applications is available to domestic and international clients. Particularly for clients unfamiliar with FDA requirements for submission, a large part of our service is advising clients as to what is required and / or recommended for a successful submission.

Service doesn't end when the clearance letter arrives with the K-number. Registration and listing, avoiding and solving detained entry problems and more are part of packages available to clients.

HCPCS Coding

Being legally permitted to market your medical device is one thing; actually selling it is another. If your product is considered durable medical equipment, your customers and distributors will ask for the HCPCS Code. It's a good idea to have the HCPCS Level II Coding verification request filled out and ready to send before getting clearance from the FDA. As soon as the clearance letter arrives, the coding request can be sent out, meaning that your product will be in the insurance reimbursement coding system.

US State Device Manufacturer Registrations

Several US states have establishment listing requirements for medical device manufacturers. Laws vary widely. While most states currently have no requirement, and devices can be freely shipped to your customers or distributors, some states require that an application be submitted and approved before devices can be shipped across state lines. Nu Device is happy to assist with determining whether your company needs to register and if so, handling the registration submission.

Doing Business with Nu Device Consulting

Services are usually performed on a project basis for a fixed cost. If ongoing assistance is needed, an hourly rate applies. Service is also available on a contract / temporary employee basis.

1600-G Golden Horseshoe Circle, Morrisville NC 27560

Tel: (919) 208-1953 Fax: (919) 249-8953

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November, 2018. All rights reserved.