Practice Test Geeks(CLE) Certified Lactation Educator Practice Test
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Regulatory Submissions & Approvals Flashcards

7 cards from real CLE practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

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  1. A lactation educator developing a mobile app that collects milk pumping data from nursing mothers must comply primarily with which regulatory framework?

    Answer: FDA Mobile Medical Application guidance (if the app meets the device definition)

    If a mobile app functions as a medical device (e.g., helps diagnose or treat a condition), it falls under FDA's Mobile Medical Application guidance and may require 510(k) clearance.

  2. Under the PUMP for Nursing Mothers Act (2022), which category of workers gained NEW break time and space protections not previously covered by the 2010 FLSA amendment?

    Answer: Salaried exempt employees (e.g., executives, administrative)

    The 2022 PUMP Act extended nursing mother protections to salaried exempt employees who were excluded from the 2010 FLSA amendment that only covered non-exempt workers.

  3. A hospital submitting data for the CDC's National Survey of Maternity Practices in Infant Nutrition and Care (mPINC) must report on breastfeeding support practices in order to:

    Answer: Benchmark facility performance and identify quality improvement opportunities

    The CDC's mPINC survey collects data on hospital lactation practices to provide benchmarking data and identify gaps for quality improvement, though participation is voluntary.

  4. Which section of the Affordable Care Act specifically prohibits insurers from discriminating against providers acting within their state scope of practice, which is relevant for lactation consultant reimbursement?

    Answer: Section 2706 – Non-discrimination in health care

    ACA Section 2706 prohibits plans from discriminating against any provider acting within their lawful state scope of practice, supporting reimbursement parity for lactation providers.

  5. When a lactation-focused nonprofit receives a federal Title V Maternal and Child Health (MCH) Block Grant, program activities must align with which overarching performance measurement framework?

    Answer: HRSA's National Performance Measures (NPMs) and State Performance Measures

    Title V MCH Block Grant recipients must report on HRSA's National Performance Measures (NPMs), which include breastfeeding initiation and duration as tracked outcomes.

  6. A CLE educator notices a breast pump flange labeled 'BPA-free' but suspects the claim is misleading. The appropriate regulatory authority to investigate this false advertising claim is:

    Answer: Federal Trade Commission (FTC)

    The FTC has authority to investigate and act against deceptive advertising claims on consumer products, including misleading 'BPA-free' environmental marketing claims.

  7. Under Joint Commission Speak Up™ standards integrated into hospital lactation programs, informed consent documentation for lactation interventions should primarily ensure that:

    Answer: Patients understand the purpose, benefits, and alternatives to the recommended intervention

    Informed consent requires that patients understand the purpose, benefits, risks, and alternatives to proposed interventions before agreeing to proceed with care.