On April 18 an FDA rule governing the use of medical device data systems went into effect, implementing guidelines for IT companies that develop medical devices for health care providers.
new U.S. Food and Drug Administration rule went into effect April 18 that
regulates how hardware manufacturers can introduce new mobile medical devices
for use by health care providers.
rule was promulgated by the FDA's Center for Devices and
, which oversees regulations for companies
manufacturing, repacking, relabeling or importing medical devices in the United
States. The FDA division also regulates electronic products that emit many
forms of radiation, including lasers, X-ray systems and ultrasound equipment.
new MDDS (Medical Device Data Systems) rule classifies most health care IT
devices as Class 1 or low-risk medical devices.
the Class 1 rule, IT companies are required to register health care hardware
and software that transfer, store, convert or display health care data, Daniel
R. Matlis, president of health care and life sciences consulting firm Axendia
explained to eWEEK.
1 devices don't include products that can directly impact patients' health.
"This identification does not include devices intended to be used in connection
with active patient monitoring," the FDA states.
rule is a common-sense regulatory approach that provides clarity and
predictability for manufacturers of these data systems," Dr. Jeffrey
Shuren, M.D., director of the Center for Devices and Radiological Health, said
in a statement. "This shows our flexibility in applying regulations for
medical device data systems that are not overly burdensome for manufacturers,
but continue to assure that data stored, transferred or displayed on these systems
companies need to do an analysis of which mobile products are being marketed to
health care providers, according to Matlis. "They want to assure that
devices that collect medical data and [are] used to make clinical decisions do
so reliably," he explained.
you're a health IT vendor and not doing any device data integration today, the
ruling above is probably not very applicable to you," Sanjeev Wadhwa, a
partner and senior strategy expert for CSC Life Sciences R&D Solutions
wrote in an email to eWEEK. "However, even if you're not capturing such
data today, it's possible you'll be integrating with such devices in the future
and you may want to perform analytics on or even provide MDDS features, [so] it
would help to watch the evolution of the ruling."
FDA announced the MDDS rule on Feb. 14, and it went into effect on April 18.
Medical device manufacturers must register their health care products by May
16, and the vendors must establish and implement a quality system for design
and controls and an MDR (medical device reporting system) by April 18, 2012.
devices may include medical billing and workflow software, communication
protocols, and hardware such as wireless modems, laptops and tablets.
(electronic health record), PHR (personal health record), CPOE (computerized
physician order entry), and e-prescribing or word processing software are not
included under the MDDS rule, Wadhwa noted.
medical devices that connected to data systems were considered Class III, or
high-risk, devices. When devices are considered low risk, they don't require
premarket clearance, according to the FDA.
I device manufacturers must register with the FDA by listing their products and
making public potential adverse effects. Health care providers must report
deaths or serious injuries that MDDS products may have caused or contributed
to, Wadhwa said.
devices must also adhere to the FDA Quality Systems regulation, which requires
manufacturers to test products before marketing them.