NCLE Study Guide Part 3 out 4 with Complete Solutions!!

The FDA classifies lens material by four groups as follows: - ANSWER-Group 1-low water < 50% water, non-ionic polymers (this group includes silicone hydrogel polymers) Group 2- high water > 50% water, non-ionic polymers Group 3- low water < 50% water, ionic polymers Group 4- high water > 50% water, ionic polymers The FDA tests disinfectants for their successfulness against these four microorganism groups: - ANSWER-•gram-positive cocci •gram-negative rods •yeast •fungi "disposable lenses" - ANSWER-The FDA classification for ? means the lens is disposed of after removal. extended wear (EW) - ANSWER-The FDA classification for ? is 1 week, Continuous wear (CW) - ANSWER-refers to wearing contact lenses both during the day and while sleeping for periods of up thirty days and nights consecutively; however the FDA still recommends an overnight removal of continuous wear every 6 nights/7 days. Good Manufacturing Practices (GMP) - ANSWER-standards is that part of quality assurance which ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to thei intended use and as required by the marketing authorization (MA) or product specification. GMP is concerned with both production and quality control. FDA approval for marketing - ANSWER-All materials are tested, evaluated, and quarantined until all of the standards have been met. Lens blanks are inspected, tested