GLOSSARY

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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.

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