Are you considering making masks or gowns to help with personal protective equipment (PPE) inventory? Maybe you’re new to medical device manufacturing. Or perhaps you are looking to add PPE items to your current portfolio of products.  Then there are some things you need to consider before you proceed with PPE manufacturing.

Did you know that many types of PPE are considered medical devices?

In order to market and sell masks, protective clothing, gloves and other PPE items as medical grade protection, these products must comply with US FDA regulations. Medical device manufacturing requires specific processes and controls as specified in FDA regulation 21 CFR Part 820.

What is required?

In the United States there are three classes of medical devices (Class I, II and III). So the higher the class, the greater the degree of risk and requirements. Therefore, basic FDA requirements, may include:

While these requirements may seem overwhelming, DP Distribution & Consulting ® can help you prepare for PPE manufacturing.  First, we will guide you through the process of determining what you need to know and do. Next, we will help you set up a comprehensive quality system. Finally, our team will assist with completing and submitting the required application(s).  So contact us to see how we can help you achieve your goals.