- FDA on Sunday said it will permit limited modifications to previously cleared infusion pumps without requiring submission of a new premarket notification, as long as the change does not create an undue risk to patients.
- The policy, outlined in a guidance document, is aimed at increasing the availability and remote monitoring capabilities of infusion pumps and related accessories used to treat patients infected with COVID-19 during the pandemic.
- Effective immediately, the new policy is the latest in a series of medical device guidances issued in recent weeks to address the needs of healthcare providers and patients during the public health emergency.
Patients infected with COVID-19 may require continuous infusion of medications, nutrition or other fluids, meaning there's increased demand for the associated devices. FDA is aiming to ensure adequate supply while also supporting technologies that allow for a safe physical distance between care providers and COVID-19 patients.
In a new guidance document, the agency laid out that it does not intend to object to limited modifications to the indications, functionality, hardware, software, design or materials of devices used to support patients requiring continuous infusion therapy. The policy applies where a modification is made to the device that normally would trigger the requirement of a new 510(k) premarket submission.
The goal in giving more flexibility to companies is to address manufacturing limitations or supply shortages. The new policy applies for the duration of the crisis.
"We believe this approach will help manufacturers that want to add production lines or manufacture at alternative sites which may have different manufacturing equipment to increase manufacturing capacity and supply and reduce supply chain interruptions and manufacturing bottlenecks," the agency said.
Examples of devices covered in the guidance include large volume parenteral, syringe, patient-controlled analgesia, and ambulatory infusion pumps and their accessories. Potential modifications could involve the design, intended use, material, chemical composition, energy source, or manufacturing process of a device.
Changes to an infusion pump motor could allow an alternate supplier to meet required design specifications, FDA said. Or, in another example, an alternate supplier of infusion pump accessories could meet the established performance of an FDA-cleared device.
The agency cited additional situations that could involve remote monitoring or manual control of an infusion pump without physically entering the patient's room; transfer of electronic drug library information over a wireless or wired network connection; use of infusion pumps not indicated for ground or air transport of patients; and use of infusion pumps for patient populations, such as pediatrics, that are not referenced in the device labeling.
FDA also is interested in interacting with manufacturers of infusion devices that are not currently legally marketed in the U.S. as well as manufacturers not previously engaged in medical device manufacturing with capabilities to increase supply of these devices.
In other recent policy changes designed to improve access to devices during the pandemic, FDA has allowed modifications to some respiratory devices and relaxed rules on the manufacture and use of ventilators amid fears of a shortage of the breathing machines. The regulator has also permitted greater use of remote patient monitoring technologies to reduce hospital visits and minimize risk of exposure to COVID-19.