3D Printing And The Shifting Legal Landscape For COVID-19
With the COVID-19 pandemic creating a shortage of critical medical supplies, such as swabs for diagnostic tests, personal protective equipment and ventilators, owners of 3D printers around the world—from leading industrial manufacturers to individual makers—are mobilizing to fill the gap.
Individuals, universities, corporations and government agencies are working together to quickly develop and obtain emergency regulatory authorizations or approvals for various 3D-printed products. Prominent technology companies, device manufacturers and members of the additive manufacturing community are collaborating in unprecedented ways to share intellectual property and engineering expertise to rapidly produce safe and effective medical supplies for health care professionals.
As designers and manufacturers adapt to assist in the fight against COVID-19, the legal landscape around 3D printing is also shifting and responding with increased protections from liability and reduced barriers to production. At the same time, there are important regulatory, intellectual property and other legal considerations to be mindful of in relying on these protections.
This article highlights key issues for the 3D printing community regarding the scope of new immunities, the evolving US Food and Drug Administration regulatory landscape for COVID-19 products, and intellectual property rights considerations.
Enhanced Immunities Under the PREP Act
The liability risks in the US for the 3D printing of medical supplies in response to the COVID-19 pandemic diminished dramatically with the Public Readiness and Emergency Preparedness Act declaration by the secretary of the US Department of Health and Human Services, which was effective Feb. 4 and subsequently amended on April 10.1 The HHS secretary also issued an advisory opinion on April 14 further addressing the scope of immunity during the COVID-19 pandemic under the PREP Act. 2
The COVID-19 declaration provides liability immunity to covered persons who engage in certain activities related to covered countermeasures against COVID-19.
The covered countermeasures against COVID-19 include, among other items, any diagnostic and any other device used to treat, diagnose, cure, prevent or mitigate COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, or any device used in the administration of any such product, and all components and constituent materials of any such product.3 The April amendment further expanded the covered countermeasures to include respiratory protective devices approved by the National Institute for Occupational Safety and Health. Additional administrative and executive orders have also further expanded the included measures.4
Generally, products for the treatment or prevention of a disease would need to be approved or otherwise permitted by the FDA. However, in addition to immunity for products that are approved, licensed or cleared by the FDA, the COVID-19 declaration provides immunity from liability for unapproved medical supplies that are made for emergency use in connection with the COVID-19 pandemic and shipped to government agencies or those working on their behalf when: (1) those supplies are authorized under an emergency use authorization, (2) described in emergency use instructions issued by the Centers for Disease Control and Prevention or (3) subject to an investigational device exemption or investigational new drug exemption.5
Accordingly, to assist in the governmental response to COVID-19, the COVID-19 PREP Act declaration opens more pathways for 3D manufacturers to rapidly produce and provide medical supplies that have not gone through the FDA approval process. The liability immunity under the PREP Act extends to covered persons and their officials, agents, and employees.
Importantly for individuals engaged in 3D production, covered persons includes, among others, manufacturers, distributors, suppliers or licensors of any product, intellectual property, service, research tool or component or other article used in the design, development, clinical testing, investigations or manufacturing of a covered countermeasure.6
Immunity under the PREP Act is not absolute, and does not extend to activities outside the scope of the current declaration, to death or serious physical injury from willful misconduct, certain foreign claims, or claims not causally related to the administration or use of a covered countermeasure.
Enhanced Immunities Under the Defense Production Act
In addition to the immunity provided under the PREP Act, the president's executive order of March 18 invoking the Defense Production Act provides additional immunities to certain entities producing medical supplies, whether by 3D printing or otherwise in particular circumstances. 7
The March executive order invoked the DPA to increase the production of masks and ventilators in response to COVID-19.
When properly invoked, the DPA authorizes the president and the HHS secretary in certain circumstances to compel prioritized sales of health resources to the US government, and direct industry to allocate resources (e.g., materials, facilities) to meet US demand for health care supplies needed to respond to COVID-19. The medical device DPA order covers General Electric, Hill-Rom Holdings, Medtronic, ResMed, Phillips and Vyaire Medical and a separate order covers the procurement of N95 face masks from 3M.
The president retains authority to invoke the DPA more broadly across the industrial sector to force prioritization of governmental orders and allocation of resources to government production. Although the scope of the orders that ultimately will be issued under the DPA in response to COVID‑19 remains to be determined, 3D printing capabilities may be important to or required for fulfillment of certain orders.
Those entities specifically covered by a DPA order and producing medical supplies, at the direction of the government (whether by 3D printing or otherwise) in compliance with a DPA order receive additional governmental immunities from liability that are designed to address the myriad liability concerns presented by such orders, such as claims of potential breach of contract, product liability, and intellectual property infringement.
Although immunity under the DPA is not absolute, and there are significant limitations, no person complying with the DPA may be held liable for damages or penalties for any act or failure to act resulting directly or indirectly from compliance with a rule, regulation, or order issued under the DPA.
Relaxation of Certain FDA Regulatory Requirements
As with any form of medical product manufacturing, 3D-printed medical products should be safe, effective and properly labeled for their intended use. Products intended to treat, diagnose, cure, prevent, or mitigate disease such as COVID-19 are regulated by the FDA, regardless of whether they are manufactured by 3D printing techniques or other methods.
In response to the urgent need for PPE such as masks, gloves and gowns for use by health care workers as well as respirators and other medical devices and supplies, the FDA has taken a variety of significant actions to make it easier for 3D printers to produce medical supplies. To ensure compliance, it is important to understand the specific regulatory requirements that are being relaxed for COVID-19 responses, and the conditions, such as required labeling, that these products are still required to satisfy.
The FDA has provided specific guidance to address questions regarding 3D printing during the pandemic in FAQs. The FDA also previously issued general guidance on "Technical Considerations for Additive Manufacturing Medical Devices," which provides more detailed recommendations on technical considerations for 3D printing. These materials are important for additive manufacturers to review.
With respect to 3D-printed materials, the FDA has adopted a risk-based approach, relaxing some enforcement requirements in ways that facilitate the use of 3D-printed products to expand availability of important products, with more limited requirements for products perceived as less risky.
The FDA has issued specific guidance as well as emergency use authorizations, as further explained below, for face masks, shields, respirators, ventilators and other products to fight the COVID‑19 pandemic. It is important to review and follow the requirements of the FDA publications applicable to the particular COVID-related products being produced.
While allowing use of 3D-printed products, the FDA still cautions that 3D-printed PPE may not provide the same level of effective protection as some other conventionally manufactured types of PPE due to technical challenges and might not meet the same testing and production standards as FDA-approved or cleared medical products.
Guidance on Face Masks and Shields
FDA guidance indicates that for the duration of the public health emergency, the FDA does not intend to object to the distribution and use of face masks, with or without a face shield (but not including a respirator), for medical purposes without compliance with certain of the agency's regulatory requirements, provided that the face masks: (1) do not create an undue risk in light of the public health emergency, (2) are not intended to provide liquid barrier protection and (3) are labeled as specified in the guidance.
Specifically, the FDA does not intend to object if manufacturers distribute such face masks without submitting a premarket clearance application and without complying with the agency's establishment registration and device listing requirements, quality system manufacturing requirements, correction and removal reporting requirements, and unique device identifier labeling requirements.
According to the FDA, to not create an undue risk to the public, such face masks should include labeling that: (1) accurately describes the product as a face mask (versus a surgical mask or filtering face mask respirator) and lists body contacting materials (which do not include drugs or biologics); (2) makes recommendations to sufficiently reduce the risks of use (such as recommendations against: use in surgical settings or where significant exposure to liquid, bodily or other hazardous fluids, may be expected; use in a clinical setting where the infection risk through inhalation exposure is high; and use in the presence of a high intensity heat source or flammable gas); and (3) does not include intended uses that would present an undue public health risk, such as uses for antiviral protection or related uses, uses for infection prevention or reduction or related uses, or particulate filtration claims.
The FDA has also recently issued two emergency use authorizations related to face masks and face shields. The first EUA authorizes the use of face shields by health care providers as PPEs in a health care setting in accordance with CDC recommendations to cover the front and sides of the face and provide barrier protection.
The second EUA authorizes face masks (but not surgical masks for liquid barrier protection) intended for use by members of the general public, including health care providers in health care settings, to cover their noses and mouths, in accordance with CDC recommendations, to prevent the spread of SARS-CoV-2 during the COVID-19 pandemic.
The FDA subsequently clarified in a reissued version of the second EUA that the scope of the face masks EUA is limited to the use of face masks as a "source control" and not as PPE, explaining that source control means preventing the transmission of infection through a person's respiratory secretions produced when speaking, coughing or sneezing. Such face masks are not intended for use by health care providers as PPEs, so they are not substitutes for respiratory protective devices or surgical face masks.
The FDA has waived its quality system requirements for face shields and face masks that fall under those EUAs, however, the shields and masks must comply with the specific conditions, including labeling requirements and adverse event reporting requirements, set forth in the respective EUAs.
Face shields generally are exempt from the agency's premarket clearance requirements even absent the guidance policy, but the FDA also does not intend to enforce compliance with the quality system and other requirements referenced above if specified conditions are met.
Surgical masks intended to provide liquid barrier protection must meet more stringent testing standards (including with respect to fluid resistance and flammability) in addition to labeling requirements to fall within the scope of the enforcement discretion policy described in the guidance.
Guidance on Respirators
With regard to respirators, the CDC has published on its website a list of alternatives to FDA-cleared or National Institute for Occupational Safety and Health-approved N95 respirators that have been approved under standards used in other countries.8 For the duration of the public health emergency, when FDA-cleared or NIOSH-approved N-95 respirators are not available, the FDA does not intend to object to the distribution (including importation) and use of respirators identified in the CDC recommendations despite any lack of compliance with specified FDA requirements, including premarket clearance and quality system requirements.9
In addition, the FDA has issued EUAs that authorize certain filtering facepiece respirators, including NIOSH-approved and imported non-NIOSH-approved disposable filtering facepiece respirators, for use in health care settings by health care personnel.10 For manufacturers of authorized respirators, the FDA has waived its quality system requirements, but such manufacturers must comply with the conditions set forth in the respective EUA and, in the case of NIOSH-approved respirators, any applicable NIOSH standards.
For devices that do not fall within the scope of those EUAs, the FDA is interested in working with manufacturers on additional device-specific EUAs, which may include manufacturers of masks and respirators that are not currently legally marketed in the US as well as manufacturers who have not previously manufactured masks or respirators but have the capabilities to increase supply of such devices.11
Guidance on Complex Products, Accessories and Components
Manufacturers or facilities who wish to 3D print complex products or devices are encouraged to discuss with the FDA directly. The FDA also recommends that anyone who wishes to 3D print accessories or components work with the relevant medical device manufacturers that have the required expertise to ensure that the printed products are effective for their specific medical purposes. Working with the applicable device manufacturer is also important from an intellectual property perspective as discussed below.
Note, however, that modifications to existing devices that are not cleared/approved, authorized by the FDA under the EUA authority, described in emergency use instructions issued by the CDC, or studied under an investigational device exemption may not be subject to the PREP Act immunity protections described above so these additional regulatory actions may be desirable to seek.
With regard to ventilators, the FDA further authorized an umbrella EUA on March 24 for ventilators, ventilator tubing connectors and ventilator accessories, which could include items such as 3D-printed tubing connectors for multiplexing ventilator use. The EUA permits the use of medical devices or alternative products as medical devices in health care settings if those products meet the criteria for safety, performance, and labeling as determined by the FDA. A list of the ventilators, tubing connectors and accessories authorized under that EUA is available on the agency's website.
On April 22, the FDA issued an FAQs document responding to questions that the FDA has been receiving about the open source approach to facilitating the availability of ventilator designs and software. Among other topics, the FAQs document addressed who is responsible for submitting a premarket notification (510(k)) or obtaining an EUA for a device, regulatory considerations when using published ventilator software or third-party 3D printing software files to make ventilator accessories, and how marketing submissions leveraging open sourced software will be reviewed by FDA.
In the FAQs document, the FDA also helpfully noted that if manufacturers have questions about the applicability of the FDA's Quality System regulation to their specific situation, they can contact the FDA at COVIDManufacturing@fda.hhs.gov.
In the April 22 document, the FDA also noted that it will interact with applicants through the pre-EUA and EUA process to determine what information is needed for each EUA request and provided a link to the "Ventilator EUA Interactive Review Template."
Manufacturers of 3D-printed products may submit a request to the FDA in order to have their products added to the umbrella EUA and thus authorized for use in COVID-19 patients, thereby bringing them within PREP Act protections. The FDA has indicated its interest in working collaboratively and expeditiously with new manufacturers of devices to see if an EUA can be granted.12
Although it can be more difficult for third parties with designs for modifying or extending the use of ventilators to obtain an EUA without working with the ventilator manufacturer of a cleared or approved device, efforts to develop and obtain authorization for various alternative ventilators and connectors, including 3D-printed designs, have been widely reported.
Regarding 3D-printed accessories or components for medical devices, such as valves for ventilators, if original parts are not available, the FDA recommends using plans and designs from original parts where possible and verifying that any 3D-printed products fit and work properly before they are used in a clinical setting.
Evolving Landscape on Intellectual Property Risks
Governmental immunities, open licensing initiatives and public sentiment in light of dire shortages of medical equipment are facilitating innovation and significantly decreasing the likelihood of intellectual property infringement liability for providers of 3D image files and 3D printers of COVID-19-related products in response to the pandemic.
However, it remains important for providers of 3D image files and 3D printers to understand that intellectual property rights of third parties may be implicated by the designs they are using and products they are printing, and to try to respect those third-party intellectual property rights and follow paths to producing products that are licensed, subject to immunity, or otherwise do not infringe.
Many 3D-printing designs for medical device parts or masks parts (typically image files such as CADs) are available online as open-source or in the public domain and are free for anyone to download and use to print. Such designs lack intellectual property protection that excludes others from using the designs. Accordingly, subject to compliance with any requirements imposed on the use of such files, the users who post the designs and the printers who use those designs would be insulated from infringement liability for using such designs.
However, both those who post designs and those who use designs to 3D print should not assume that simply because a design is available online it means that the design itself or the product being printed is not subject to intellectual property protection. Both posters and printers of designs should still be cautious when using image files and must pay attention to whether the files they find online indicate they are protected by some form of intellectual property.
The most common form of intellectual property protection on the designs themselves are copyrights and the most common intellectual property protecting the printed products are utility patents (which would cover the end result of the print, i.e., the device or product itself and how it operates, functions, or what it does).
Sometimes the design or printed article could be covered by a design patent (e.g., appearance or ornamental features of the mask only) or sometimes by trademarked design (e.g., trade dress protection on the look and feel of the mask). Although not the only circumstances in which third parties may have rights (and does not itself guarantee that any third party has rights), any time a visible circle R or a circle C or the words patent protected appear on a design, the user should assume a third party may have relevant rights.
Individuals and entities who provide 3D-printable product designs or printing instructions online for others to print, may still be subject to liability if those designs or the resulting printed products are protected by a third party's intellectual property rights. This is called indirect infringement. However, in order for an instruction-provider to be found liable for this type of indirect or induced infringement, under US law, the instruction-provider must be found to know, or be willfully blind to, the fact that the design in question infringes another's rights.13
As opposed to the provider of the image, if a physical product, such as a ventilator piece or other medical device component, is covered by a US patent, absent a license, whoever manufactures that product in the US, whether by 3D printing or otherwise, would be directly infringing the patent.
The PREP Act or DPA, if applicable, offer immunities from infringement liability, and immunities from patent infringement liability may also be available for companies that are producing 3D-printed products under contracts with the federal government pursuant to by US Code Title 28 Section 1498. That section gives the federal government the right to use patented inventions in certain circumstances without permission while paying the patent holder some reasonable compensation. That statute also typically requires persons seeking relief to sue the US government, rather than the contractor.
In the event the immunities discussed above are not conferred on either the provider of the design or the printer of a design or item that is protected by US intellectual property rights, such as a patent granted by the US Patent and Trademark Office, the primary way to avoid potential intellectual property liability is to seek a license or covenant-not-to-sue from the applicable rights holder, such as the medical device manufacturer.
To aid in the COVID-19 fight, a variety of leading companies who own relevant intellectual property have committed to providing open licenses to their proprietary intellectual property at no cost/royalty-free for the purpose of diagnosing, preventing, containing and treating COVID-19. Use of the intellectual property is allowable without having to negotiate a special agreement, or pay a royalty or other fee to the patent or copyright holder.
For example, medical device manufacturers, such as Medtronic PLC and Smiths Group PLC, and tech companies such as Amazon, Facebook, HPE, Intel, IBM, Microsoft, and Sandia National Laboratories have signed what is known as the Open COVID Pledge, pursuant to which they are granting free temporary licenses to use their patented and/or copyrighted technologies in the fight against the novel coronavirus without fear of infringement.14
Additionally, universities such as Harvard, Stanford and MIT have committed to similar more open licensing models for their intellectual property for the fight against COVID under separate arrangements.15 Other organizations may join these initiatives or release their own open license programs. These programs will help generally reduce the risks of infringement claims, but to take advantage of any of these program with respect to particular third party intellectual property, check the specifics of the program to understand the scope of the rights grants.
Although given the urgent public health situation, intellectual property rights holders are choosing to grant open licenses, or otherwise may elect not to enforce their rights with respect to 3D-printed products created in response to the pandemic, especially where medical products are concerned, working with the applicable rights holders can help from both a public safety and product performance perspective and is still advised.
The 3D printing community has the ability to play an important role in alleviating shortages in critical medical supplies for the COVID-19 pandemic. Regulatory requirements and liability risks have already been materially reduced in response to the global crisis in a variety of ways that make it substantially easier and less risky for 3D manufacturers to participate in medical product manufacturing. Other similarly directed initiatives are being announced frequently. This more open environment provides unprecedented opportunities for innovation and the use of additive manufacturing in the battle against COVID-19.
However, notwithstanding the potential immunities, to mitigate liability risk and produce safe and effective materials for the health care workers on the front lines of the battle against COVID-19, it remains important for 3D manufacturers to work collaboratively with governmental agencies and existing medical device manufacturers, to include adequate disclaimers and labeling on their products and not make unsubstantiated claims or claims of intended uses that would present an undue public health risk, to respect the intellectual property rights of others, and to implement appropriate controls regarding the designs, materials, processes, and finished products in order to produce high quality medical materials.
Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 52, 15198 (Mar. 17, 2020), ("Initial Declaration"); Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 73, 21012 (published Apr. 15, 2020) ("Amendment to Declaration").
Dep't of Health and Human Services, Advisory Opinion on the Public Readiness and Emergency Preparedness Act and the March 10, 2020 Declaration Under the Act (Apr. 14, 2020) ("Advisory Opinion to Declaration").
See Food and Drug Administration, Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised): Guidance for Industry and Food and Drug Administration Staff, 8 (April 2020).
See Food and Drug Administration, Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff, 12 (March 2020).