class III device

0.02 sec.

class III device

Regulatory affairs A highly regulated 'high risk' medical device–eg, life-support or life-sustaining devices–eg, pacemakers and heart valves, approved by the FDA for use in humans; CIIIDs are also defined as those which pose a potentially unreasonable risk of illness or injury. See Medical device.

How to thank TFD for its existence? Tell a friend about us, add a link to this page, add the site to iGoogle, or visit webmaster's page for free fun content.

?Page tools

Printer friendly
Cite / link
Email

Feedback
Add definition

? Mentioned in

? References in periodicals archive

premarket approval

The hearing aid is considered a Class III device by the FDA -- the most stringent regulatory category for devices.

FDA Seeks Civil Penalties from Hearing Aid Maker by ConsumerAffairs.com / consumeraffairs.com

The hearing aid is considered a Class III device by the FDA--the most stringent regulatory category for devices.

FDA seeks civil penalties from device maker by Adverse Event Reporting News

Section 510(k) of the MDA allows a Class III device to bypass the PMA requirement if the FDA deems it is "substantially equivalent" to a device that was marketed prior to 1976—the year the MDA took effect.

Riegel V. Medtronic: A Win For Medical Technology by Mondaq Business Briefing

More results

Medical browser

? Full browser

clasp-knife release
clasp-knife spasticity
class
class action lawsuit
class I device
class II biologic safety cabinet
class II device
class III device
class recall
class switching
classic
classic cesarean section
classic complement pathway
classic hemophilia
classic migraine

Class I railway
Class Identifier
Class II
Class II
Class II
class II antigens
class II antigens
class II antigens
class II antigens
class II antigens
class II biologic safety cabinet
Class II cabinet
class II device
Class II gene
Class II histocompatibility molecule
class II invariant chain peptide

Class II MHC
Class II PI 3-kinase
Class II PI 3-kinases
Class II railroad
Class II-associated invariant chain peptide
Class II-associated invariant chain peptide
Class II-associated invariant chain peptide
Class III
class III device
Class III NFA firearm
Class III PI 3-kinase
Class III railroad
Class implementation file
Class Improvement Plan
Class Improvement Program
Class in New Zealand
Class in object-oriented programming

Class in the contemporary United States
Class in the United States
Class in the United States, circa 2004
class Insecta
class Insecta
class Insecta
class Insecta
Class interest
Class interest
Class interests
Class interests
Class Interface Size
class interval
class interval
class interval
class intervals

Medical Dictionary

Free Tools:	For surfers: Free toolbar & extensions \| Word of the Day \| Help For webmasters: Free content \| Linking \| Lookup box \| Double-click lookup \| Partner with us

All content on this website, including dictionary, thesaurus, literature, geography, and other reference data is for informational purposes only. This information should not be considered complete, up to date, and is not intended to be used in place of a visit, consultation, or advice of a legal, medical, or any other professional. Terms of Use.