Certified Lactation Specialist Regulatory Submissions & Approvals 2

Question 1

Which FDA regulation classifies breast pumps as Class II medical devices requiring 510(k) premarket notification?

Accepted Answer

21 CFR Part 880

Answer

Breast pumps fall under 21 CFR Part 880, which covers general hospital and personal use devices including breast pumps classified as Class II.

Question 2

What is the primary purpose of a 510(k) submission for a new breast pump design?

Accepted Answer

To demonstrate substantial equivalence to a legally marketed predicate device

Answer

A 510(k) submission demonstrates that a new device is substantially equivalent in safety and effectiveness to a legally marketed predicate device.

Question 3

Under the Baby-Friendly Hospital Initiative (BFHI), which organization provides the accreditation designation in the United States?

Accepted Answer

Baby-Friendly USA

Answer

Baby-Friendly USA is the national authority that administers and awards Baby-Friendly Hospital designations in the United States.

Question 4

When a lactation consultant submits documentation for IBCLC recertification, which body processes and evaluates those submissions?

Accepted Answer

International Board of Lactation Consultant Examiners (IBLCE)

Answer

IBLCE is the independent certifying body that oversees IBCLC certification, recertification, and evaluates continuing education documentation.

Question 5

Which document must a facility submit to demonstrate compliance with state lactation support laws when applying for a new maternal care license?

Accepted Answer

A lactation policy and procedure manual approved by clinical leadership

Answer

State licensing bodies typically require a facility to submit approved lactation policies and procedures as evidence of compliance with maternal care standards.

Certified Lactation Specialist Practice Test

Certified Lactation Specialist Practice Test

Certified Lactation Specialist Regulatory Submissions & Approvals 2