Certified Lactation Specialist Regulatory Submissions & Approvals 2 — Questions and Answers
Question 1: Which FDA regulation classifies breast pumps as Class II medical devices requiring 510(k) premarket notification?
- 21 CFR Part 880 (Correct answer)
- 21 CFR Part 870
- 21 CFR Part 862
- 21 CFR Part 892
Correct answer: 21 CFR Part 880
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?
- To demonstrate substantial equivalence to a legally marketed predicate device (Correct answer)
- To prove the device is superior to all existing pumps
- To obtain a full premarket approval (PMA)
- To register the manufacturing facility only
Correct answer: To demonstrate substantial equivalence to a legally marketed predicate device
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?
- Baby-Friendly USA (Correct answer)
- The Joint Commission
- American Academy of Pediatrics
- WHO Regional Office
Correct answer: Baby-Friendly USA
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?
- International Board of Lactation Consultant Examiners (IBLCE) (Correct answer)
- International Lactation Consultant Association (ILCA)
- Academy of Breastfeeding Medicine (ABM)
- American Nurses Credentialing Center (ANCC)
Correct answer: International Board of Lactation Consultant Examiners (IBLCE)
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?
- A lactation policy and procedure manual approved by clinical leadership (Correct answer)
- A 510(k) premarket notification
- A HIPAA business associate agreement
- An NDA with formula manufacturers
Correct answer: A lactation policy and procedure manual approved by clinical leadership
State licensing bodies typically require a facility to submit approved lactation policies and procedures as evidence of compliance with maternal care standards.
Question 6: The Affordable Care Act Section 4207 requires employers to provide which accommodation related to lactation?
- Reasonable break time and a private space for expressing milk for one year after birth (Correct answer)
- On-site lactation consultants for all employees
- Paid maternity leave of at least 12 weeks
- Free breast pumps supplied by the employer
Correct answer: Reasonable break time and a private space for expressing milk for one year after birth
ACA Section 4207 amends the FLSA to require reasonable break time and a non-bathroom private space for nursing employees to express milk for up to one year postpartum.
Question 7: When reporting an adverse event involving a rental breast pump malfunction to the FDA, which reporting pathway is typically used by healthcare facilities?
- MedWatch Safety Reporting Program (Correct answer)
- 510(k) amendment submission
- VAERS reporting system
- NDA safety update report
Correct answer: MedWatch Safety Reporting Program
Healthcare facilities report adverse events involving medical devices, including breast pumps, through the FDA's MedWatch Safety Reporting Program.
Certified Lactation Specialist Regulatory Submissions & Approvals 2
Which FDA regulation classifies breast pumps as Class II medical devices requiring 510(k) premarket notification?