What does it mean to be FDA registered?

A discussion on the importance of FDA registration to ensure QMS in plastics machining facilities

 

For businesses and facilities involved in the production and distribution of medical devices, FDA Registration is a requirement to machine or manufacture any plastic material that will be used in the United States medical market.

 

Therefore, if your manufacturer or machining shop is not FDA registered, start looking for a new facility with the appropriate certifications and industry standard regulations. There is no compromise on safety and quality assurance when working with plastics for critical applications.

 

At AIP, we not only guarantee a quality assurance program, we are FDA registered, ISO 13485:2016 certified, AS9100D:2016 certified and ITAR certified. As a precision plastics machining company with over 35 years’ experience, we have worked with medical OEMs and R&D representatives to machine critical components for the medical and specialized industrial sectors. We understand the value of a transparent QMS program through the FDA Registration.

 

In this issue of our monthly blog, we discuss what it means to be FDA registered and how it emphasizes our commitment to quality, safety and excellence.

 

Why should a plastics machining facility be FDA registered?

 

FDA registration is a set of mandates that regulate manufacturing operations for facilities involved in the production and distribution of medical devices in the United States. It determines whether a facility has the appropriate resources, including equipment and personnel, to perform the manufacturing operations. This registration includes an annual audit to ensure compliance with the FDA registration requirements.

 

This audit includes an annual registration fee for device establishments. Additionally, most facilities that are FDA registered must provide a list of devices that are made there and the activities that are performed on those devices.

 

As per the FDA device registration and listing, “If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also provide the FDA premarket submission number (510(k), PMA, PDP, HDE, De Novo).”

 

The use of an unregistered device or material can be very dangerous. This means it hasn’t been listed, cleared, tested or approved by the FDA. What if the device is unsafe or ineffective for the user or client?

 

Learn about how to ensure sterilization and industry
standards applied to plastic machined medical applications

 

Read More

 

Additionally, using a device not listed with the FDA means there is no protection for a healthcare or wellness professional should a client have a harmful experience.

 

If you’re unsure if a medical device is listed with the FDA, you can search for the manufacturer in the Registration & Listing Database.

 

How does FDA registration help AIP serve the medical market?

 

At AIP, we promise “unrivaled expertise and unparalleled results”. These guiding principles have made us seek out the highest levels of certifications and industry standards for these major markets: aerospace, medical, power and energy and specialized industrial.

 

We know that product durability, cleanliness and safety are essential for our customers. Our FDA registration allows us to create highly precise and extremely resilient machined plastics for critical applications.

 

We have been successfully audited by some of the most stringent OEMs across all market sectors. Our plastics are processed with strict hygienic procedures to ensure the highest level of sanitation down to the sub-molecular level.

 

At AIP, quality assurance is a norm not only for our customers but for ourselves. As an FDA registered facility, we are proud to offer a complex quality assurance process that focuses on product quality, fast delivery and cost-effective options.

 

What about AIP Precision Machining allows us to achieve FDA Registration

 

“At AIP, it’s about the people and their commitment to this company as a team,” said MacDonald. “We have been FDA registered for the last 35 years, and our team consistently displays attention to maintaining the standards of this regulation on the machine shop floor. That’s what makes us better every day at meeting the needs of our valued customers.”

 

If you are interested in learning more about our quality assurance
program or have a machined plastic part design, reach out to our team.

 

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