FY

fiscal year

GAO

Government Accountability Office (formerly General Accounting Office)

GHTF

Global Harmonization Task Force

GMP

good manufacturing practices

HHS

Department of Health and Human Services (formerly Department of Health, Education, and Welfare)

HIMA

Health Industry Manufacturers Association

IG

inspector general

IOM

Institute of Medicine

IVDD

in vitro diagnostic medical devices

MAUDE

Manufacturer and User Device Experience database

MD EPINET

Medical Device Epidemiology Network

MDA

Medical Device Amendments

MDR

medical-device report

MedSun

Medical Product Surveillance Network

NB

notified body

NCDR ICD

National Cardiovascular Data Registry for implantable cardioverter defibrillators

NDA

new drug application

NSE

not substantially equivalent

OC

Office of Compliance

OCP

Office of Combination Products

ODE

Office of Device Evaluation

OMB

White House Office of Management and Budget

ORA

Office of Regulatory Affairs

OTS

off-the-shelf

PMA

premarket approval

QSR

quality-system regulations

SE

substantially equivalent

SMDA

Safe Medical Devices Act

STED

summary technical document

UDI

unique device identification



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement