The US Food and Drug Administration has released a quartet of guidance documents that lay out enforcement policies for infusion pumps, ECMO and cardiopulmonary bypass devices, ophthalmic devices, and electronic thermometers.
The immediately-in-effect guidances were issued in response to the ongoing COVID-19 crisis in the US; they will be revoked when the national public health emergency is over.
Infusion Pumps And Accessories
The FDA’s guidance for infusion pumps and accessories, dated 4 April, says manufacturers can make “limited modifications” to those devices without having to deal with the red tape of applying for a new 510(k) from the agency.
“FDA does not intend to object to limited modifications to the indications, functionality, hardware, software, design or materials of FDA-cleared devices used to support patients who require continuous infusion therapy … for the duration of the public health emergency,” the document says.
Pumps covered by the guidance include large volume parenteral (LVP) infusion pumps, syringe infusion pumps, patient-controlled analgesia (PCA) infusion pumps and ambulatory infusion pumps; the document includes a detailed listing of eligible devices.
The guidance says the policy will give device makers the flexibility to make changes to address “manufacturing limitations or supply shortages.”
The FDA’s doc offers as an example a company that makes changes to its infusion pump motor so it can use an alternate supplier and still meet the pump’s design specs.
“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 guidance says.
The agency makes clear in its doc that any changes must not create an undue risk. The guidance offers examples of modifications that do and don’t create such risk.
The FDA wants to talk to “manufacturers who have not previously been engaged in medical device manufacturing.”
Further, the FDA says it won’t object to manufacturers making modifications to their pumps that allow for increased remote monitoring, including the use of wireless and/or Bluetooth capabilities.
For those types of changes, “manufacturers should develop and implement appropriate cybersecurity controls,” the guidance says.
And pump accessories such as tubing, filters and manifolds can be used beyond their expiration date as long as it doesn’t create any undue risks. Again, the guidance offers examples of what would and wouldn’t create such risk.
The agency’s document also includes a listing of international standards and other FDA guidances designed to aid companies “in designing, evaluating and validating modifications made under this policy.”
Firms that modify their pumps should make sure that the labeling clearly explains to users the changes that were made, the guidance says.
The FDA also says it wants to “interact” with “manufacturers of infusion devices that are not currently legally marketed in the US.”
The guidance urges such companies to provide information about their unapproved pumps so the agency can determine whether to grant emergency use authorizations (EUAs) for them.
Finally, the document says the FDA wants to talk to firms that “have not previously been engaged in medical device manufacturing with capabilities to increase supply” of the pumps.
“This may include US manufacturers in other manufacturing sectors,” the guidance says. “FDA intends to work collaboratively with these manufacturers through its EUA process.”
ECMO And Cardiopulmonary Bypass Devices
Meanwhile, a 6 April enforcement policy guidance from the FDA targets devices used for extracorporeal membrane oxygenation (ECMO) therapy, as well as cardiopulmonary bypass devices.
The guidance says makers of those devices can also make “limited modifications” to the products without seeking out a new 510(k), as long as the changes don’t create undue risks.
And just like the infusion pump guidance, this document also includes examples of changes that do and don’t create such risk, as well as recommendations for what manufacturers should include in the modified devices’ labeling.
The guidance also offers a listing of international standards that firms should use as they make device changes.
“Manufacturers must document changes to their device in their device master record and change control records, and make this information available to FDA, if requested,” the document says.
The guidance applies to devices that pump or oxygenate blood by:
- Moving the blood to a component that pumps/oxygenates the blood;
- Controlling or monitoring gas flow for the circuit; or
- Controlling the temperature of the blood.
It doesn’t apply, however, “to devices intended only for extracorporeal carbon dioxide removal, because such devices may not oxygenate the blood at clinically meaningful levels.”
Nevertheless, the agency says makers of those types of devices can request an EUA, as can “manufacturers of ECMO devices, or manufacturers of cardiopulmonary bypass devices seeking indications greater than six-hour use to be used for ECMO, that are not currently legally marketed in the US.”
Remote Ophthalmic Assessment And Monitoring Devices
A third enforcement policy guidance, this one also dated 6 April, says makers of remote ophthalmic assessment and monitoring devices can make “limited modifications” to their products so they can be used remotely.
Such devices include visual acuity charts, visual field devices and general-use ophthalmic cameras – all products that are exempt from 510(k) requirements.
Tonometers, which do require 510(k) clearance, also fall under the scope of the guidance.
The ophthalmic devices “have the potential to be connected to a wireless network through Bluetooth, wi-fi or cellular connection to transmit a patient’s ophthalmic parameters directly to their eye care provider or other monitoring entity,” the guidance notes.
It goes on: “Modified use of these devices may facilitate patient management by health care providers while reducing the need for in-person treatment during the COVID-19 public health emergency, and may help reduce the risk of exposure for patients and health care providers.”
Once again, any changes to the devices should not create undue risks, and the document offers examples. A listing of international standards that companies should use is also provided.
Further, labels for the modified devices should include information for users detailing the changes that were made.
Clinical Electronic Thermometers
Finally, a fourth enforcement policy guidance from the FDA dated 4 April allows makers of clinical electronic thermometers that aren’t 510(k)-cleared to distribute the devices for use, as long as they don’t create undue risks.
The agency “believes such devices will not create such an undue risk” as long as the company making them follows regulatory requirements found in the agency’s Quality System Regulation or international quality systems standard ISO 13485.
The thermometer also should have marketing authorization from another country or conform to international standards, a listing of which is provided in the guidance.
The document adds that the thermometer’s labeling should include “a clear description of the available data on the device’s indications or functions,” including:
Method of determining temperature;
Potential risks; and
Cleaning and reprocessing instructions.
The labeling should also note that the thermometer isn’t FDA approved or cleared.