Posted 20 June 2014
By Alexander Gaffney, RAC
In a stark reversal, US Food and Drug Administration (FDA) regulators today said they would exempt medical device data systems (MDDS)—systems used to collect and store data from other medical devices like weight scales and glucose meters—from regulation, abandoning an earlier plan to regulate them as Class I ("low-risk") medical devices.
The announcement comes more than three years after FDA down-classified MDDS devices from Class III ("high-risk") to Class I. While the move would have subjected MDDS devices to far fewer regulations—just "general controls" meant to ensure that the devices met minimal standards of safety and efficacy—FDA said subsequent reflection determined that the devices "pose little risk" and didn't require active oversight.
While every medical device and procedure carries a certain level of risk," said Bakul Patel, FDA's senior policy advisor for health IT issues, he noted that FDA is intent on focusing on "devices that carry greater levels of risk [than MDDS]."
This, he continued, will allow developers of MDD systems to "focus on making these products better able to operate amongst various devices and technology systems," and to focus less on maintaining compliance with unnecessary regulations.
FDA's new policy, as explained in the new guidance, Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices, pertains to the following types of devices:
- MDDS subject to 21 CFR 880.6310,
- Medical image storage devices subject to 21 CFR 892.2010, and
- Medical image communications devices subject to 21 CFR 892.2020.
"This means that for devices that meet the definitions in the regulations listed above, the FDA does not intend to enforce compliance with the regulatory controls, including registration and listing, premarket review, postmarket reporting and quality system regulation for manufacturers of these types of devices," FDA explained.
There are some "limitations" to the exemption, according to FDA, which will require premarket notification submissions, also known as 510(k)s. "However, even when subject to these limitations, FDA does not intend to enforce compliance with the regulatory controls for devices that meet the definitions identified by the above regulations," FDA noted.
The guidance also makes changes to FDA's Mobile Medical Applications guidance to reflect the new approach.
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices
FDA Voice Post