The Food and Drug Administration (FDA), the US authority responsible for medical devices regulation, issued guidance on supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) submissions in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19).

Regulatory Background

The new FDA Guidance is intended to implement temporary measures necessary to ensure the availability of the vitally important medical devices during the pandemic and Public Health Emergency associated. To accelerate the implementation, the document enters into force immediately without prior consultations prescribed by the general rules. However, medical device manufacturers and other industry representatives are still allowed to submit their comments and suggestions to be considered by the Agency in the future. 

It is also important to emphasize the temporary nature of the document – the new rules introduced by the present FDA guidance shall remain valid only during the Public Health Emergency announced earlier in February 2020.

Application submission

The purpose of the FDA guidance is to assist medical device manufacturers in dealing with the COVID-related factors interrupting the manufacturing processes and supply chains. The document does not set forth additional rules and obligations medical device manufacturers shall follow, but only provides certain recommendations regarding the particular way to maintain normal business operations and remain compliant with the applicable regulatory requirements in spite of the impact caused by the pandemic, as well as by the additional restrictive and quarantine measures associated thereto. 

In order to expand and ensure the availability of medical devices used to treat the complications and respiratory illnesses caused by the COVID-19 and thus facing a significant increase in demand. For this purpose, the FDA has already issued special guidance documents and introduced additional flexibilities for medical device manufacturers focused on the design and development of the vitally important medical devices, such as ventilators or infusion pumps.

FDA on PMA and HAD Supplements 

The present FDA guidance describes special measures implemented by the Agency with regard to the modifications the medical devices already approved under the Premarket Approval (PMA) or Humanitarian Approval frameworks. In particular, the Agency states that it would not object to making certain changes to the abovementioned devices and allow medical device manufacturers to make such devices available on the market without prior approval, providing that such changes do not impact significantly the safety and performance of the device in question. 

In particular, the scope of the document covers the following types of changes to the FDA-approved medical devices:

  • Changes to the design of the device reasonably necessary due to the temporary unavailability of some of the components,
  • Changes to the manufacturing process required due to the implementation of the social distancing practices,
  • Changes related to the manufacturing sites,
  • Changes to the processes related to packaging. 

The Agency states that the aforementioned flexibilities would be sufficient to avoid potential disruptions to the manufacturing process and shortages in the supply of medical devices that are critically important in the context of the COVID-19 outbreak. 

New Regulation in Detail

As it was previously mentioned, the present FDA guidance describes additional flexibilities to be introduced by the Agency in order to expand and ensure the availability of the vitally important medical devices. The Agency allows medical device manufacturers to make limited changes to the FDA-approved medical devices, providing that such changes do not create additional risk to the patients and are reasonably necessary to be implemented in order to maintain an uninterrupted supply of medical devices during the pandemic. In particular, the scope of the requirements to be waived under the new framework covers, inter alia, the following types of prior submissions:

  • PMA or HDE supplement,
  • 30-day notice,
  • 180-day or real-time PMA supplement,
  • 75-day HDE supplement.

In order to assist medical device manufacturers in applying the new regulatory framework, the Agency also describes the particular circumstances under which it will find the changes suggest as ones that do not result in a significant increase in the risk associated with the use of the device. For instance, such circumstances include:

  1.  Changes usually requiring the submission of a PMA or HDE supplement:
    1. Changes to the components of a medical device in question, reasonably necessary to address potential interruptions in the manufacturing process due to the impact of COVID-related factors, or
    2. Device material changes to be made as to the result of changes in manufacturing methods, providing that such changes do not impact the safety or performance of the device. 
  2. Changes usually requiring the submission of a PME or HDE 30-day notice:
    1. Changes to the supplier of the materials and components,
    2. Changes to the equipment used during the production process,
    3. Changes that are necessary due to the implementation of the social distancing rules,
    4. Changes resulting from the full or partial automation of the processes (e.g. the automation of the packaging process),
    5. Addition of the new manufacturing lines.
  3. Changes usually requiring a PMA or HDE site-change supplement:
    1. Significant changes in manufacturing sites, or changing to another manufacturing site. 
medical device manufacturer

FDA Guidance on Restricted Changes

Besides the scope of allowed changes, the FDA guidance on supplements for the PMA or HDE submissions also outlines the changes that, according to the position by the Agency, could result in a significant increase in the risk the patients are being exposed to when using the device. The Agency states that such modifications include the changes to:

  • The intended use of the device (e.g. new indications),
  • The labeling of the device,
  • The sterility assurance level (SAL) or sterilization method used by the medical device manufacturer,
  • The quality control (e.g. its elimination or significant reduction),
  • The manufacturing procedures in the form of full automation, providing that such automation hasn`t been previously verified.

The scope of restricted changes also includes ones impacting the performance of the device, in case if such changes are not reasonably necessary to address the unavailability of certain components due to the COVID-related issues. 

Obligations of Medical Device Manufacturers  

The FDA guidance also describes the obligations of medical device manufacturers arising from the application of the new framework. In particular, it is required to document any and all changes made to the device, and such records should be provided to the FDA upon request. As it is explicitly stated in the FDA guidance, the records shall cover the following aspects:

  • The indication of all applicable standards,
  • The information about verification and validation of the software and/or hardware,
  • The details about functional, mechanical, or temperature testing.

The Agency also recommends medical device manufacturers to include information about the changes to the next report submitted to the FDA.

Summarizing the information described hereabove, the present FDA guidance implements a new regulatory framework intended to expand and ensure the availability of the vitally medical devices during the pandemic and provides medical device manufacturers with the recommendations regarding the particular actions they are entitled to take in order to address the impact to the manufacturing process and normal business operations caused by the COVID-related factors.  

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