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.
Read the first 7 Regulatory Submissions & Approvals flashcards as text
A manufacturer seeking FDA clearance for a hospital-grade multi-user breast pump must primarily demonstrate:
Answer: Substantial equivalence to a legally marketed predicate device via 510(k)
Multi-user hospital-grade breast pumps are Class II devices that require 510(k) premarket notification showing substantial equivalence to a predicate device already on the market.
Under the WHO International Code of Marketing of Breast-milk Substitutes, which of the following actions by a formula company is explicitly prohibited?
Answer: Distributing free formula samples directly to mothers
The WHO Code prohibits the promotion of breast-milk substitutes to the general public, including distributing free samples directly to mothers or through healthcare facilities.
Which OSHA standard most directly applies to workplace lactation accommodations and requires employers to assess physical hazards that could affect nursing employees?
Answer: OSHA General Duty Clause (Section 5(a)(1)) and the PUMP Act
The General Duty Clause requires employers to provide a safe workplace, and the PUMP Act (2022) strengthened nursing mothers' rights; together they govern lactation accommodation and hazard assessment.
A lactation educator at a WIC clinic must ensure that formula prescribed through WIC complies with which federal standard for infant formula composition?
Answer: FDA 21 CFR Part 107 – Infant Formula
All infant formulas distributed through WIC or sold commercially must comply with FDA 21 CFR Part 107, which sets mandatory nutrient levels, quality controls, and notification requirements.
When a CLE wants to report a suspected adverse event linked to a breast pump accessory (e.g., a contaminated valve), the appropriate FDA reporting pathway is:
Answer: MedWatch voluntary safety reporting (Form FDA 3500)
Healthcare providers and consumers can report device-related adverse events to FDA through the MedWatch voluntary safety reporting program using Form FDA 3500.
Under FERPA, a CLE working in a university lactation center may share a student-mother's lactation records with campus health services WITHOUT written consent only if:
Answer: There is a legitimate educational interest or health/safety emergency
FERPA permits disclosure without consent for school officials with a legitimate educational interest or in health/safety emergencies, which can apply to campus health coordination.
Which federal agency is responsible for enforcing the Surgeon General's Call to Action to Support Breastfeeding through public health program requirements tied to federal funding?
Answer: Health Resources and Services Administration (HRSA)
HRSA administers Maternal and Child Health Block Grants and other federally funded programs that align with the Surgeon General's Call to Action to Support Breastfeeding.