Free gift with purchase of $75 or more! Gift selection available at checkout.

Why are breast pumps required to have FDA approval?

Selecting the right breast pump for your needs comes with a lot of decisions. There are many types of pumps and lots of terminology to learn for all the working parts of a pump. There is another very important piece of information you should look for when purchasing a breast pump and that is if it has been approved by the FDA.

The FDA (Food and Drug Administration) is part of the Department of Health and Human Services and is responsible for protecting public health. They oversee the safety and efficacy of many products including breast pumps. The FDA’s responsibilities extend to all 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S. territories and possessions.(1)

Breast pumps are considered medical devices. There are 3 different classifications based on how a medical device works and the potential risk of using the device.(2) There is quite a broad range of products that fall into the various categories.

  • Class 1 - these are low risk medical devices including face masks, bandages and manual breast pumps.
  • Class 2 - medical devices in this class are considered to pose a medium risk to users. In this class are products like pregnancy test kits, battery operated breast pumps and electric breast pumps.
  • Class 3 - this is the highest risk category and products in this category include devices that get implanted in the body like a pacemaker or breast implants.

FDA registration

Any company that manufactures, repacks or re-labels a breast pump must be registered with the FDA.(2) It only means that the FDA is aware of that manufacturer and their devices. It doesn't mean the product they are selling is safe or approved by the FDA. 

FDA cleared

These pumps have gone through a process of 510(k) submission and have been found to be similar to previously approved pumps. Even if the previously approved pump is no longer considered safe or no longer on the market, it can still be considered a predicate for clearance of the new pump. It may not have had current testing for safety. Getting FDA clearance can take close to 6 months.

510(k) submission

This shows that the pump is substantially equivalent to a previously approved pump and it is safe and effective. There is a long list of criteria to meet for 510(k) submission including: 

  • describing the pump and it’s specifications 
  • how it is intended to be used 
  • photographs or drawings of the pump design 
  • comparison to predicate pumps 
  • how it will be labeled 
  • how it will be cleaned
  • performance testing

The above are only some of the details needed for submitting the 510(k). It is a process that takes a couple months at the least and can cost between $45,000 - $65,000.

FDA approved

This is what you want to look for. The process for getting approval is rigorous and ensures that the pump you are buying has met the criteria for safety for use under the review of the FDA. In order to be approved, the pump must be proven to comply with FDA safety regulations. Once the pump is FDA approved, it must continue to be compliant for as long as it is available to the public. The approval process can take anywhere from a year to several years and cost between $50,000 - $200,000.

When a pump is FDA approved, it has to continue to work as it is supposed to and remain safe for the user. If there are concerns about the device, the FDA will issue a recall and work with the manufacturer to resolve the problem. Breast pumps that are not FDA approved do not have this built in safety feature of continued monitoring.

Third-party lab testing

Third-party testing is done by a separate lab not affiliated or connected with the manufacturer of the pump and therefore completely unbiased. Results from tests on how well the breast pump performs, it’s safety and efficacy let customers know the validity of the claims made about a pump by the company. This level of transparency from a company makes them more trustworthy.

Beware

  • Companies manufacturing breast pumps outside the US may not be registered with the FDA and their pump may not have gone through the process of testing its safety for you, the user. This leaves you no protection if you do experience an injury from using a knock-off product.
  • Watch out for pump manufacturers who have only done testing themselves and not by third-party labs. Their tests may not be as objective as they should be and results can be skewed.
  • If you have been injured by a regulated pump, you should report the problem to your doctor and you can file a report at MedWatch.

A lot of time and money goes into getting a breast pump approved by the FDA. Purchasing an FDA approved device gives you peace of mind knowing it has met set safety standards and will operate how it is advertised to. You get what you pay for. Beware of pumps that are less expensive,, knock off products that have not met the requirements for approval by the FDA. There are other regulatory agencies globally, however the FDA remains the leading regulating the protection and promotion of public health.(3)

 

Footnotes:

  1. https://www.fda.gov/about-fda/fda-basics/what-does-fda-do
  2. https://www.aspenlaser.com/the-difference-between-fda-registered-fda-approved-and-fda-cleared/
  3. https://www.fda.gov/about-fda/changes-science-law-and-regulatory-authorities/fda-goes-global 

Resources:

https://www.greenlight.guru/glossary/510k-submission

https://www.qima.com/quality-control-services/laboratory-testing?lang=en&xtor=SEC-5&matchType=p&kw=laboratory%20testings&device=c&loc=9003320&network=g&placement=T1-BROAD-EN-SEM-USONLY&campaign=general&serviceType=lab-testing&campaignid=283818485&adgroupid=19352232485&sc=ppc&creative=318772379429&gclid=Cj0KCQiA-K2MBhC-ARIsAMtLKRuGDPN_k2-eoXDl76RCsIgeLhIz8rf4bkpMq5NHTwCwJxjjmjvLCdwaAmUQEALw_wcB

https://www.drugwatch.com/fda/recalls/

https://www.fda.gov/medical-devices/consumer-products/breast-pumps

https://www.fda.gov/consumers/consumer-updates/what-know-when-buying-or-using-breast-pump

https://www.hygeiahealth.com/blog/can-insurance-companies-offer-manual-breast-pump/ 

https://www.greenlight.guru/blog/fda-clearance-approval-granted

https://www.i3cglobal.com/fda-510k/

https://www.sandiegouniontribune.com/sdut-fda-rules-breast-pump-reuse-contradict-its-consume-2011apr06-htmlstory.html

https://www.fda.gov/about-fda/what-we-do#mission 


Leave a comment

Please note, comments must be approved before they are published