Many Arizona manufacturers are pivoting production to personal protective equipment (PPE) and other medical devices. The Arizona Commerce Authority (ACA) and the Arizona Manufacturing Extension Partnership (Arizona MEP) are assisting manufacturers with supply chain equipment needs, improved production lines and sourcing for raw materials. Find resources for manufacturers below.
Reenergizing Arizona's Economy
Governor Doug Ducey announced a gradual and responsible step approach to breathe life back into Arizona’s economy. The ACA collected all the state’s guidance as businesses resume operations. Manufacturers will also find additional support for reopening with guides from national associations and companies.
Arizona Manufacturing Extension Partnership
Arizona MEP’s mission is to make every Arizona manufacturer the most successful business it can be. To support manufacturers through the COVID-19 crisis, Arizona MEP experts will:
- Identify manufacturing companies that can provide PPE goods
- Assist with supply chain equipment
- Work to improve production lines
- Help to source raw materials
- Inform manufacturers on workforce benefits and programs
Contact your advisor directly, or click below.
FDA requirements for PPE goods
To help ensure medical devices are safe and effective, the FDA has established Quality Systems Regulations and Good Manufacturing Practices. Manufacturers are expected to use these regulations and practices to maintain consistent product quality and to guide performance testing to make sure that their products conform to the standards. See the FDA Current Good Manufacturing Practices for more information.
PPE manufacturing instructions
Manufacturers should explore the types of masks, how your production capabilities align with the type of mask, what FDA regulations apply and define your customers. Please be sure to review the FDA guidance for Gowns, Other Apparel, and Gloves.
Please see the following additional manufacturing information from the Open Source COVID19 Medical Supplies (OSCMS) medical review team:
3M released a guide on N95 masks and N95 respirators to help manufacturers differentiate standard versions and surgical versions. To compare and contrast, view this Technical Bulletin.
Please review the information from the FDA: COVID-19 Related Guidance Documents for Industry.
Entry information to import PPE or other medical devices
In response to the COVID-19 pandemic, the FDA and Customs and Border Control have modified the import requirements. Please see the U.S. Customs and Border Protection’s Information for Filing PPE and Medical Devices during COVID-19 guidance.
These instructions clarify the types of PPE that can be imported without engaging with the FDA. It also includes information about the type of information importers can submit to facilitate their entries. The FDA has adjusted its import screening to further expedite imports of legitimate products and is continually monitoring import systems to prevent and mitigate any potential issues.
There are many medical supplies and devices that are in short supply. You should explore the types of products you would like to manufacture, how your production capabilities align with the type of product, what FDA regulations apply, and who your customers will be.
Medical supplies information from OSCMS
Please see the FDA’s guidance on Enforcement Policy for Sterilizers, Disinfectant Devices and Air Purifiers.
Medical devices information from OSCMS
- Negative Pressure Rooms
- Non-Contact Thermometers
- Ventilator Machines
- Hospital Beds
- Oxygen Concentrators
- Pulse Oximeters
- Non-Heated Humidifier
- Infusion Pumps
The Food and Drug Administration issued the FDA Policy for Diagnostic Tests to help accelerate the availability of novel coronavirus (COVID-19) diagnostic tests developed by laboratories and commercial manufacturers during the public health emergency.
You should explore the processes, equipment, and raw materials that are required to make hand sanitizer and how your production capabilities align with the requirements. Please see OSCMS guide for Hand Sanitizer for additional information.
For manufacturers interested in producing alcohol for use in hand sanitizer, the FDA released guidance for manufacturers who are not currently registered drug manufacturers that would like to produce alcohol for hand sanitizers. The Temporary Policy for Manufacture of Alcohol guide provides information for firms that manufacture alcohol for incorporation into alcohol-based hand sanitizer products.
Please carefully consider the guidance document (Ventilators and Accessories) from the FDA as you determine whether you can assist in the effort to support the manufacture of ventilators. This guide is intended to provide a policy to help expand the availability of ventilators as well as other respiratory devices and their accessories during this pandemic. This policy will create more flexibility for manufacturers that make device modifications to address current manufacturing limitations or supply shortages. This approach will help manufacturers that want to add production lines or manufacture at alternative sites to increase manufacturing capacity and supply and reduce supply chain interruptions and manufacturing bottlenecks. Note that ventilators are Class 3 Medical Devices and subject to stringent FDA regulation.
The FDA issued guidance to provide restaurants and food manufacturers with flexibility regarding nutrition labeling so that they can sell certain packaged foods during the COVID-19 pandemic. This guidance does not apply to foods prepared by restaurants. For more information, view the FDA Temporary Policy Regarding Nutrition Labeling.
The Arizona Manufacturing Extension Partnership’s (Arizona MEP) mission is to make every Arizona manufacturer the most successful business possible. To support manufacturers through the COVID-19 crisis, Arizona MEP experts have been:
- Identifying manufacturing companies that can provide PPE goods
- Assisting manufacturers with supply chain equipment needs by connecting buyers and manufacturers
- Working with clients to improve production lines to meet the demand of PPE
- Helping to source raw materials for manufacturers
- Informing manufacturers on workforce benefits and programs
Arizona MEP experts worked with F.A.B.R.I.C. in Tempe to analyze their manufacturing system and provide a plan to scale their outputs. Angela Johnson, co-founder of F.A.B.R.I.C. in Tempe said, “Thanks to the Arizona Commerce Authority’s Manufacturing Extension Partnership, we’ve been working with a lean manufacturing expert who has helped us with efficiency in the manufacturing process. With his help, we’ve determined that we can manufacture 500 isolation gowns a day once we ramp up a little more.”