3D Printing: COVID-19 Regulatory & Performance Considerations

The information below is provided to give manufacturers regulatory and
product performance considerations related to producing clinically reviewed designs.

Updated: July 14, 2020

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Product Type

Face Shields Community Use Face Mask Surgical / Clinical Use Face Mask1 Mask Tension Release Bands Personal Assistance Device Nasopha-
ryngeal Swabs

Manufacturing Regulatory Considerations

IFU – Instructions for Use

Manufacturers are responsible for telling the user the intended use, how to wear/use the device, storage, assembly, cleansing, and disposal information. Moreover, information on materials, warnings, performance testing, adverse reactions, and a disclaimer should be included.
General Device Labeling Requirements

Labeling

Medical devices sold in the US, from manufacturing through distribution to a patient, must be labeled.
Device Labeling; UDI System Link

Product Tracking

Device manufacturers must track how many devices are distributed to each customer and offer a method for receiving, recording, and tracking potential issues with devices.
Medical device tracking

GMP – Good Manufacturing Practice

Manufacturers must establish and follow quality systems to help ensure their products consistently meet applicable requirements and specifications. Typically, a manufacturer following good manufacturing practice (GMP) means they maintain a relevant certification for all respective quality systems utilized in the production of devices.
QS Regulation and GMP; Overview of Device Regulation

Unadulterated Product

We recommend manufacturers use the design as presented and strictly adhere to the recommended practices outlined in the data package from the NIH 3D Print Exchange prior to printing, assembling, and shipping a part.

Adverse Event Tracking

Manufacturers must report to the FDA upon discovery of an adverse event where the device may have caused or contributed to a death or serious injury. As of 2018, certain manufacturers may be able to submit voluntary summary reports of adverse events to the FDA.
How to Report Medical Device Problems; Mandatory Reporting Requirements

Registration and Listing

Owners or operators of places of business (or establishments/facilities) involved in production and distribution of medical devices intended for use in the US must register annually with the FDA through a process known as establishment registration.
Device Registration and Listing

FDA Resources, Guidance and EUA Links

Face Mask FDA Online Resource

Face Shield EUA FDA Guidance
May 2020
FDA Guidance
May 2020
FAQ on Testing for SARS-CoV-2

Minimum Performance Considerations

Chemical Compatibility

Chemical characterization of devices should be conducted within the framework of a risk management process to understand what interactions and components may alter the physicochemical characteristics of the device.
Use of ISO 10993-1 – Biological Evaluation

Biocompatibility

Risk assessment of the device should consider chemical toxicity of the materials, the processing method, and manufacturing methods in relation to any unacceptable biological response to the device. Exposure duration of the device should be considered in evaluating biological impacts on users.
Standard: ISO 10993

Flammability

Proper flammability standards should be adhered to based on the class of device being manufactured. For surgical masks intended for use in the operating room, Class 1 and Class 2 flammability materials are recommended by FDA.
Surgical Mask Guidance
Standard: ASTM F2100-19

Liquid Barrier

The fluid resistance is the ability of the mask’s material to demonstrate a liquid barrier and resist penetration of blood and body fluids. FDA recommends using ASTM F 1862 for surgical masks.
Surgical Mask Guidance
Standards: ASTM F1862-17; ASTM F2100-19

Face Seal Fit

Face seal fit can be evaluated with a fit test, either qualitative or quantitative according to OSHA guidelines. A fit factor can also be determined as an estimated ratio of concentration of a substance in the ambient air to its concentration in the respirator when worn.
OSHA-Accepted Fit Test Protocols
Respiratory PPE Definitions
Standard: 29CFR 1910.134 App A

Loose Loose

Splash Resistance

Splash resistance refers to protection of the facial area and associated mucous membranes from splashes, sprays, and spatters of bodily fluids.
Face Shields for Infection Control

Offgassing

Offgassing, or outgassing, refers to the release of volatile compounds as a gas from the materials of the device.
Outgassing Wiki

Cleanliness

A method of cleaning the device should be established to mitigate the presence of foreign debris or contaminants which can affect testing validity or patient safety. Standards: ASTM F3127-16 FDA Validation of Cleaning Processes

Compatible Sterilization Methods

Compatible sterilization methods are developing and are defined as processes to clean and disinfect soiled medical devices to render them safe for handling and to the extent necessary for subsequent processing.
Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency

NIH 3D Print Exchange Design ID’s

3DPX-013306
3DPX-013309
3DPX-013314
3DPX-013359
3DPX-013374
3DPX-013375
3DPX-013403
3DPX-013406
3DPX-013409
3DPX-013421
3DPX-013444
3DPX-013456
3DPX-013532
3DPX-013616
3DPX-013830
3DPX-013883
3DPX-013884
3DPX-013887
3DPX-013989
3DPX-013319
3DPX-013321
3DPX-013354
3DPX-013384
3DPX-013477
3DPX-013505
3DPX-013512
3DPX-013519
3DPX-013545
3DPX-013603
3DPX-013607
3DPX-013661
3DPX-013674
3DPX-013677
3DPX-013690
3DPX-013693
3DPX-013807
3DPX-013885
3DPX-013934
3DPX-014004
3DPX-014080
3DPX-014173
3DPX-013429
3DPX-013836
3DPX-013410
3DPX-013440
3DPX-013574
3DPX-013675
3DPX-013380
3DPX-013564
3DPX-013615
3DPX-013752
3DPX-013793
3DPX-013860
3DPX-013967
3DPX-014017
3DPX-014103
3DPX-014147
3DPX-014188
3DPX-014357
3DPX-014417
1If you are making a Surgical / Clinical Use Face Mask for community use, regulatory considerations for community use face mask apply
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