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Manufacturers' Opportunity Amid COVID-19 Uncertainty

A Buckley King Advisory

March 26, 2020

Dominic A. Frisina

Government is pulling out all the stops to clear manufacturing bottlenecks hampering production of essential medical products. Companies that would otherwise shutter production lines can be part of the solution by pivoting to produce medical products and components for medical devices. Ford and Tesla have made headlines lately by partnering with medical device manufacturers to re-purpose automotive production capacity for making much needed ventilators. This is made possible, in part, by emergency suspension of FDA regulations outlined in a guidance document published on March 22nd. According to the FDA guidance, it will not require the usual 510(k) premarket notifications for certain changes to FDA-cleared devices.  

The FDA's intention is to provide greater supply flexibility in sourcing components in the face of shortages and supply chain interruptions. For example, a manufacturer of ventilators can alter design specifications to integrate a motor or tubing sourced from an alternate supplier. The guidance specifically identifies several ventilator components that are temporarily exempt from 510(k) premarket notification:

    • Motors, batteries, and other electrical components;
    • Material changes to components in the gas pathway or with patient tissue contact;
    • Aerosol filters; and,
    • Hardware modifications implementing remote monitoring and remote adjustment of ventilator parameters (i.e., to avoid unnecessary exposures by medical professionals).

The FDA further provides resources for manufacturers to validate and test hardware and software design changes. Recognized Consensus Standards can be accessed through the FDA website.

Similar opportunities have arisen in the area of alcohol-based hand sanitizers, where the FDA has provided guidance to manufacturers that wish to pivot their manufacturing capacity to fill this evolving need. In addition to providing a recipe, the FDA provides guidance to manufacturers on how to conduct quality control and labeling, and how to register their facility and products in the FDA Drug Registration and Listing System.

Loosening regulations has created opportunities for manufacturers to keep their employees working while helping the nation deal with the COVID-19 crisis. Even manufacturers that have never sold into the medical device industry can help ease the burden on the nation's supply chain while at the same time preserve capabilities that can be quickly reactivated when the storm has lifted.

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