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In 2018, the FDA announced a streamlined approval pathway for certain medical devices used in rural healthcare settings. Previously, manufacturers...

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In 2018, the FDA announced a streamlined approval pathway for certain medical devices used in rural healthcare settings. Previously, manufacturers seeking to distribute these devices in underserved areas faced extensive documentation requirements and lengthy review processes that could take up to three years. The new pathway reduces approval time to six months and eliminates several costly regulatory steps. Healthcare policy analysts expect that medical device availability in rural areas will significantly improve because the regulatory changes mean that _____

Which choice most logically completes the text?

A

bringing devices to rural markets will become more accessible and cost-effective.

B

rural patients will become more interested in advanced medical technology than urban patients.

C

the FDA will provide refunds to manufacturers for previous application fees.

D

original medical device designs will become harder to obtain in rural areas.

Solution

Step 1: Decode and Map the Passage

Part A: Passage Analysis Table

Text from PassageAnalysis
"In 2018, the FDA announced a streamlined approval pathway for certain medical devices used in rural healthcare settings."
  • What it says: 2018: FDA → new streamlined pathway for rural medical devices
  • What it does: Introduces a recent policy change by the FDA
  • What it is: Context/background information
"Previously, manufacturers seeking to distribute these devices in underserved areas faced extensive documentation requirements and lengthy review processes that could take up to three years."
  • What it says: Before: manufacturers faced extensive docs + long reviews (≤3 yrs)
  • What it does: Explains the old system's problems and delays
  • What it is: Background/contrast to new system
"The new pathway reduces approval time to six months and eliminates several costly regulatory steps."
  • What it says: New way: 6 months approval + eliminates costly steps
  • What it does: Presents the specific improvements of the new system
  • What it is: Evidence/details of change
"Healthcare policy analysts expect that medical device availability in rural areas will significantly improve because the regulatory changes mean that _____"
  • What it says: Analysts expect rural device availability ↑ because changes mean [blank]
  • What it does: Presents expert prediction with missing reasoning
  • What it is: Conclusion with missing logical connection

Part B: Passage Architecture & Core Elements

Main Point: The FDA's new streamlined approval pathway will improve medical device availability in rural areas by making the approval process faster and less costly for manufacturers.

Argument Flow: The passage establishes a recent policy change, contrasts it with previous lengthy and expensive requirements, details the specific improvements, then presents an expert prediction that needs logical completion based on those improvements.


Step 2: Interpret the Question Precisely

This is a fill-in-the-blank question asking us to choose the best logical connector. The answer must create the right relationship between what comes before and after the blank.


Step 3: Prethink the Answer

  • The new pathway makes two key changes: it cuts approval time dramatically (from up to 3 years to 6 months) and eliminates costly regulatory steps
  • These changes would logically make it easier and cheaper for manufacturers to get their devices approved for rural markets
  • When something becomes easier and less expensive to do, companies are more likely to do it
Answer Choices Explained
A

bringing devices to rural markets will become more accessible and cost-effective.

✓ Correct
  • This directly connects the regulatory improvements to manufacturer behavior
  • "More accessible" reflects the reduced complexity and time requirements
  • "Cost-effective" reflects the eliminated costly regulatory steps
  • Perfectly matches our prethinking about why availability would improve
B

rural patients will become more interested in advanced medical technology than urban patients.

✗ Incorrect
  • Claims rural patients will become more interested than urban patients
  • The passage discusses regulatory changes affecting manufacturers, not patient interest levels
  • Nothing in the passage suggests rural vs. urban patient preference differences
C

the FDA will provide refunds to manufacturers for previous application fees.

✗ Incorrect
  • Suggests FDA will provide refunds for previous application fees
  • The passage mentions eliminating future costly steps, not refunding past fees
  • This doesn't explain why future device availability would improve
D

original medical device designs will become harder to obtain in rural areas.

✗ Incorrect
  • Claims original designs will become harder to obtain in rural areas
  • This contradicts the entire premise that availability will "significantly improve"
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