CLE Regulatory Submissions & Approvals 2

Question 1

Under FDA regulations, electric breast pumps are classified as which type of medical device?

Accepted Answer

Class II (special controls and 510(k) clearance)

Answer

Electric breast pumps are Class II medical devices requiring 510(k) premarket notification demonstrating substantial equivalence to a predicate device.

Question 2

Which federal law requires employers with 50 or more employees to provide reasonable break time and a private space for nursing mothers to express milk?

Accepted Answer

Break Time for Nursing Mothers Act under the FLSA

Answer

The Break Time for Nursing Mothers Act, an amendment to the Fair Labor Standards Act (FLSA), mandates break time and private space for up to one year after birth.

Question 3

A hospital seeking Baby-Friendly designation must submit evidence of compliance with all Ten Steps. Which agency administers this designation in the United States?

Accepted Answer

Baby-Friendly USA (BFUSA)

Answer

Baby-Friendly USA is the accrediting body authorized by WHO/UNICEF to administer the Baby-Friendly Hospital Initiative in the United States.

Question 4

When submitting a new lactation support program proposal to a hospital's Institutional Review Board (IRB), which factor most determines whether full board review is required?

Accepted Answer

Research involves greater than minimal risk to subjects

Answer

IRB full board review is triggered when research involves greater than minimal risk to participants, regardless of cost or enrollment size.

Question 5

Under HIPAA, which of the following disclosures of a breastfeeding patient's health information does NOT require written authorization?

Accepted Answer

Disclosing to treatment team members involved in her care

Answer

HIPAA's Treatment, Payment, and Healthcare Operations (TPO) exception allows disclosure to treating providers without patient authorization.

(CLE) Certified Lactation Educator Practice Test

(CLE) Certified Lactation Educator Practice Test

CLE Regulatory Submissions & Approvals 2