Manufacturing & Supply Chain

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:

• N95 Respirators
• Face Masks 
• Goggles 
• Examination Gloves 
• Gowns 

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

• Nasal Cannulas 
• Nasal Catheters 
• Flow-Splitters for Oxygen Supply 
• Thorpe Tube Flowmeter 
• Oxygen Masks 

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 
• Laryngoscopes 
• Infusion Pumps 

Diagnostic tests

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. 

Hand Sanitizer

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.

Ventilators

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.

As manufacturers resume operations, consider these resources from industry organizations, professional groups and federal agencies to plan for safe and responsible operations.

GUIDES FOR MANUFACTURERS

PROTECTING YOUR BUSINESS FROM COVID-19

The MEP National Network provides a guide for manufacturing employers to help them prepare and react to COVID-19 impacts including, staff, visitor and travel policies, employee health and communication plans.

VIEW GUIDE

RESPONDING TO A COVID-19 EXPOSURE AT YOUR BUSINESS

The MEP National Network provides a checklist for employers of what they should do if they suspect a COVID-19 exposure has occurred at their facility.

VIEW CHECKLIST

NEW OPERATIONAL PRACTICES TO CONSIDER IN THE TIME OF COVID-19

The National Association of Manufacturers (NAM) created a collection of emerging strategies and new operational practices that many leading manufacturing organizations of all sizes are considering or implementing to guide their workplaces and employees safely through the pandemic.

VIEW GUIDE

INTERIM GUIDANCE FROM CDC FOR MANUFACTURING WORKERS AND EMPLOYERS

The CDC released comprehensive resources and guides for manufacturing facilities to develop plans for continuing or resuming operations during the COVID-19 pandemic

VIEW RESOURCES

COVID-19 GUIDANCE FOR THE MANUFACTURING INDUSTRY WORKFORCE

OSHA released guidance for workers and workplaces in the manufacturing industry to reduce the risk of exposure to the coronavirus.

VIEW GUIDANCE