Acronyms

AdvaMed -
ANSI -: American National Standards Institute
ASQ -: American Society for Quality
AAMI -: Association for the Advancement of Medical Instrumentation Founded in 1967, AAMI represents nearly 7000 professionals focused on medical instrumentation. This Web site contains sections open to members and nonmembers. Areas open to nonmembers focus on meetings and events, standards, GMP/QS, publications, certification, employment, awards, and relevant links. Brief news stories are headlined on the main page and updated frequently.
510(k) -: Premarket Notification - Notification by a manufacturer that they intend to market a device similar to one already on the market.
CDRH -: Center for Devices and Radiological Health - Part of FDA responsible for enforcing medical device regulations.
DSMA -: Division of Small Manufacturers Assistance - Part of CDRH, mandated by Congress, to assist medical device manufacturers in understanding and complying with applicable FDA regulations.
EIR -: Establishment Inspection Report
EMI -: Electro-Magnetic Interference
ESD -: Electro-static Discharge
FDA -: Are you sure you're on the right page?
FDLI -: The Food and Drug Law Institute. In addition to membership and events information, this site includes a small but useful list of links and an archive of key industry documents. Articles from the Food and Drug Law Journal are listed in abstract form but not provided in their entirety. FDLI also conducts (in conjunction with the CDRH and similar organizations) a series of video conferences, which are broadcast live to download sites throughout the country (viewers need to get a satellite dish).
GMP -: Good Manufacturing Practice - Regulation covering the methods, facilities, and controls used in manufacturing, packing, storing, and installing medical devices. Now referred to as the Quality Systems Regulations ( 21 CFR Part 820 ).
HIMA -: The Health Industry Manufacturers Association. Now the Advanced Medicl Technology Association (AdvaMed ). This is a very useful web site that includes industry market data, highlights from HIMA reports, and a helpful index of industry acronyms.
IDE -: Investigational Device Exemption - The exemption from misbranding and adulteration while a device undergoes clinical evaluation to support its safety and efficacy. (21 CFR Part 812 )
IEEE -: Institute of Electrical and Electronic Engineering
IVD -: InVitro Diagnostic Devices
MassMedic -: MassMedic, the Massachusetts Medical Device Industry Council, has an impressive site carrying state-based information. Resources include survey information about the device industry, letters and position papers on FDA reform, and links to member company sites.
MDA 92 -: Medical Devices Amendments of 1992 - Clarifies both the Medical Device Amendments of 1976; and SMDA.

MDMA -: Medical Device Manufacturers Association. MDMA is a national trade association based in Washington, DC, representing mostly smaller manufacturers of medical devices, diagnostic products, and healthcare information systems. The site presents news updates on pertinent regulatory and legislative issues and provides links to member companies and government agencies.
MDR -: Medical Device Reporting - Reporting of device related injuries, deaths and device malfunctions. (21 CFR Part 803 )
NAFL -: Notice of Adverse Findings Letter - issued to firms to advise them of violative conditions. If conditions were not corrected a Regulatory Letter was issued after which other regulatory action could be taken. These letters are no longer used; a Warning letter is now issued and serves as an official warning. Regulatory action is generally not taken until after a Regulatory Letter is issued.
NAI -: No Action Indicated - Used in inspection reports and endorsements to indicate that the inspectional findings do not support regulatory action. (also see OAI, VAI)
NEMA -: National Electrical Manufacturers Association
NIST -: National Institute for Standards and Technology

OAI -: Official Action Indicated - Used in inspection reports and endorsements to indicate that the inspectional findings do support regulatory action such as seizure, injunction or prosecution. (see also NAI, VAI)
ODE -: Office of Device Evaluation - Part of CDRH that reviews Pre-Market Approval Applications and 510(k) notifications.
ORA -: Office of Regulatory Affairs - Part of FDA that coordinates field activities.
PMA -: Premarket Approval Application - Submission by a manufacturer to show that their new device is safe and effective. ( 21 CFR Part 814 )
PRP -: Problem Reporting Program - Device problem reports were received by USP from health professionals. USP forwarded the reports to FDA and the appropriate manufacturer. This system has been replaced by the MedWatch system.
QSR -: Quality System Regulations - Revised GMP regulation. ( 21 CFR Part 812 )
RAPS -: The Regulatory Affairs Professionals Society (RAPS) offers education, training, and certification programs for its 7000 members. The group's Web site has a member list and carries information about the annual RAPS convention and the regulatory affairs certification program. There are also job postings and a rundown of useful information resources.
SE -: Substantially Equivalent - The determination by FDA on a 510(k) submission that a device is equivalent to a predicate device.
NSE -: Not Substantially Equivalent - Not the determination a manufacturer wants to hear.


SMDA -: Safe Medical Devices Act - Passed in 1990 to broaden the authority of FDA to regulate devices.

VAI -: Voluntary Action Indicated - Used in inspection reports and endorsements to indicate that the inspectional findings may support regulatory action, however, the firm appears willing and able to take corrective action voluntarily.

Send suggested additions, deletions or modifications to mleal@wpi.edu
updated 11/25/2001