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
The FDA's Modernization of Cosmetics Regulation Act (MoCRA) affects lactation educators primarily because it includes mandatory registration and listing requirements for:
Answer: Topical nipple creams and balms marketed as cosmetics
MoCRA requires facilities that manufacture cosmetic products—including nipple creams and balms—to register with the FDA and list their products.
Which regulatory framework governs the operation of nonprofit donor human milk banks in the United States?
Answer: HMBANA guidelines and applicable state tissue banking laws
Human Milk Banking Association of North America (HMBANA) guidelines, combined with state tissue banking statutes, form the primary regulatory framework for nonprofit donor milk banks.
Under the Affordable Care Act, which provision most directly requires health insurance plans to cover lactation counseling and supplies without cost sharing?
Answer: Essential Health Benefits (EHB) mandate – preventive services
The ACA's preventive services mandate (Section 2713) requires non-grandfathered plans to cover USPSTF-recommended preventive services, including breastfeeding counseling, without cost sharing.
When a lactation product manufacturer makes a health claim (e.g., 'supports milk production') on packaging, which regulatory standard must that claim meet to avoid FDA enforcement action?
Answer: Significant scientific agreement (SSA) standard for authorized health claims
FDA-authorized health claims for food products must meet the significant scientific agreement (SSA) standard, while qualified health claims require a lower level of evidence with a disclaimer.
A hospital's lactation program wants to track outcomes across facilities and submit aggregate data to a state health department. Under HIPAA, this activity most likely qualifies as:
Answer: Public health reporting permitted without individual authorization
HIPAA's public health exception (45 CFR §164.512(b)) permits disclosure to public health authorities without patient authorization for authorized public health activities.
State licensure laws for lactation consultants most commonly categorize CLC/CLE credentials as:
Answer: Voluntary credential that does not confer a protected title or scope
Most US states do not yet license CLCs/CLEs as independent professions; these credentials are typically voluntary certifications without a legally protected scope of practice.
When a CLE educator submits program quality data to The Joint Commission as part of a hospital's accreditation review, the data is used to evaluate compliance with which standard category?
Answer: Provision of Care, Treatment, and Services (PC) standards
Lactation support and breastfeeding education fall under TJC's Provision of Care, Treatment, and Services (PC) standards, which address patient education and support.