The FDA will allow limited changes to certain devices so medtech companies can address manufacturing and supply chain issues due to COVID-19-related disruptions.
In a guidance released yesterday, the agency said it would allow changes to devices approved through its premarket approval (PMA) and humanitarian device exemption (HDE) pathways as long as those changes do not create an undue risk. The new guidance will remain in effect for the duration of the COVID-19 public health emergency.
It also applies to limited modifications that result in changes to a device’s performance or design specifications, circuits, components, ingredients or physical layout, which would normally require companies to submit a 180-day or real-time PMA supplement or a 75-day HDE supplement.
Manufacturers must document any changes to the device in their device master record and change
control records and make this information available to FDA, if requested. Component changes must be documented as well. Depending on the specific change, such records may include:
- Applicable standards to which the component conforms.
- Software/firmware verification and validation.
- Functional testing.
- Mechanical testing (e.g., drop, vibration).
- Temperature testing (e.g., minimum storage, maximum storage, transport).
