Medical appliance manufacturers say they are confident of getting approval for medical devices
Medical appliance makers have been told they may be able to begin selling medical devices by the end of the year after receiving assurances that they have been properly tested and can meet regulatory requirements.
The announcement Friday came as President Trump signed an executive order to begin the process of approving new medical device makers and their products, saying that he was “taking action” to make it easier for Americans to obtain affordable medical devices.
Medical device makers are already approved for more than half of the world’s markets and expect to be approved for nearly all of them in the coming months.
The medical device manufacturers Association of Medical Device Manufacturers said the move could help the industry grow rapidly as it ramps up production of medical devices, which are used in thousands of conditions worldwide.
“The medical device industry has been on a roll over the past year,” said Brian Fagan, the association’s vice president for public affairs.
“As the president has said, the health care and medical device industries are going to thrive and grow together.”
Trump has long touted the economic benefits of medical device development, saying in his 2016 campaign that he would give tax breaks to companies that would develop new medical devices for the United States.
The American Medical Association, which represents medical device companies, has repeatedly said it has seen no indication that medical device approval will affect the industry’s growth.
The AMA and the Medical Device Alliance, which includes the industry leaders, both have expressed confidence that the medical device approvals will be completed by the time the president’s order takes effect, said Peter A. Scholten, a senior vice president at the AMA.
The new order also directs the Department of Health and Human Services to issue guidelines for doctors to follow when reviewing the medical devices they prescribe, said Scholsten.
The guidelines, which would be issued by HHS in mid-March, could also provide guidance on the use of devices that can detect and diagnose diseases.
But it would not provide any guidance on whether medical devices should be used for routine medical tasks.
The guidance would not require medical device designers or manufacturers to submit their products to the Food and Drug Administration for approval, which many companies say they would prefer.
The order also prohibits the HHS secretary or acting secretary from “requiring a manufacturer to submit a device to the FDA that has not been adequately tested.”
A spokeswoman for the White House Office of Management and Budget did not immediately respond to a request for comment.
Medical devices companies have argued that the guidance could cause them to be more vulnerable to fraud and the misuse of their products.
But the guidance would also limit the type of devices the government can approve.
Under the new rule, the government cannot approve any device that requires a blood test for an indication other than cancer treatment, diabetes, or heart disease.
The devices that would be affected by the new guidance would be those that do not require a blood sample to diagnose the condition.
The industry’s chief medical device regulator, the American Medical Devices Association, also said it expects to be able apply for FDA approval of devices in January, even though it did not get approval for those devices in November.
The group has asked the FDA to allow it to submit device applications by March for devices with an “unapproved use” and “unclear purpose” before FDA approves those applications.
A spokeswoman said that agency would consider applications from medical device applicants that comply with the rules.
The FDA could also grant the industry some flexibility by giving them more time to get FDA approval before a device is required for routine use.
The administration said Friday that the Trump administration is “very confident” that medical devices will be approved before the end-of-year deadline, which was announced in an executive action Friday by the director of the FDA, Dr. Tom Frieden.
Frieden said that the administration believes that medical equipment manufacturers are doing everything they can to meet regulatory deadlines.
“We will continue to work closely with the medical industry to ensure that we get this right,” Frieden wrote in a statement.