Before going ahead with bulk medical device manufacturing, your product should get approval from the Food & Drug Administration (FDA) to reassure potential customers that it is safe to use. FDA approval is different from FDA compliance, the latter meaning only that you followed established regulations while making the product. The guide below explains the steps you need to complete to achieve the former.

How to Get FDA Approval: A Brief Overview

1. Classify Your Product

A Class I product, such as gauze or toothbrushes, typically doesn’t have as extensive of an application process as a Class II (low-to-moderate-risk) or Class III (higher risk) product. When trying to determine what category your product fits into, you can reference the FDA’s searchable database.

2. Compile Information for the Application 

You’ll either need to fill out an application for pre-market notification (PMN) or pre-market approval (PMA), depending on the classification of your product. The purpose of a PMN is to prove there are similar products currently on the market that are already FDA approved. Based on this logic, your product won’t have to undergo any clinical trials to prove its safety.

If you are instructed to fill out a PMA, this usually means you have a Class III device and that you will have to develop a prototype of your product that will be tested. The results of the clinical trials will be included in the application along with a summary of the device’s function, safety information, scientific explanations regarding its effectiveness, and a bibliography of references.

3. Provide Follow-Up Information

After sending in your information, the FDA will contact you within 15 days if there are parts of your application that need to be adjusted. You will be given 180 days to make these changes and meet their requirements.

Once your product has been green-lit for review, they will continue to contact you with follow-up questions. After this process is complete, you will be notified if your product has been officially FDA approved for medical device manufacturing.

For quality medical device manufacturing, contact Pacific Integrated Manufacturing in Bonita, CA. For over 15 years, their technicians have been working diligently to create important health care products in their 50,000-square-foot facility, using techniques such as plastic injection molding. For more information on their services, visit them online. Call (619) 921-3464 with questions.