GLOSSARY
N
| Term | Definition |
|---|---|
| NAI (No Action Indicated) |
A classification for an FDA audit that indicates that no further action is required by the inventor or company in order to seek approval for a device. |
| NCD (National coverage determination) |
One of two types of reimbursement determinations made by Medicare that provides guidance on national reimbursement coverage. Typically applies to payments for inpatient services. |
| NDA (Non-Disclosure Agreement) |
An agreement between two parties such that the party receiving confidential information from another party will not disclose the information to anyone for a fixed period of time. |
| Niche strategy |
A strategy whereby a company seeks to own the customer relationships in a specific, focused area of medicine. |
| Non-exclusive agreement |
Agreements where both parties are free to enter into agreements with other companies. |
| Non-exclusive license |
A license that allows the licensee rights of use within a given field and within whatever other limitations are provided by the license, but allows the licensor to grant similar rights to other parties. |
| Non-governmental organizations |
Non-profit organizations that are often working for a cause. These organizations provide resources and assistance to parties when those parties’ own or other governments will not or cannot. |
| Notice of Allowance |
The notice from the USPTO to indicate the patent has been accepted. |
| NSE (Not Substantially Equivalent) |
A determination by the FDA that a new device is not equivalent enough to a predicate device and therefore cannot use the 510k pathway. |