US FDA Regulation on Breast Pumps

Published On - November 24, 2020

I3CGLOBAL FDA 510k

There are three common types of breast pumps found in the market worldwide.

  1. Manual Breast Pumps
  2. Battery-powered Breast Pumps
  3. Electric Breast Pumps

FDA 510k Requirements

        1.          Classification Name

Powered Breast Pump
        2.          Regulation No.

884.5160
        3.          Product Code

HGX
        4.          Device Class

2
        5.          Submission Type

510(k)
        6.          Predicate device with link

Contact us
        7.          Type of 510k

(Traditional / Abbreviated 510k)

Traditional
        8.         

Performance Tests Names

1.      Electrical safety testing

2.      Electromagnetic compatibility testing

3.      Evaluation of vacuum performance and Backflow
        9.          Biocompatibility Tests

1.      Cytotoxicity

2.      Irritation

3.      Sensitization
      10.        Clinical Data

Not Required
      11.        Remarks /

Additional requirements

1.      Software Validation- minor level of concern

2.      Usability

3.     Risk Management

4.      Stability Studies

5.      Cleaning validation

Useful Information

Technical Biological and Clinical Characteristics FDA 510k Fees

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