On July 20, 2018, the FTC issued its final guidance on the applicability of the FTC’s rules on disclosure of medical device safety data, which will be used to evaluate the applicablity of a new medical device liability rule to all electronic medical records (EMRs).
The new rule, which applies to devices that store medical data, is part of the Federal Register’s proposed rulemaking process and is expected to be finalized in September 2019.
The FTC is currently soliciting comments on the proposed rule, but in a letter to all respondents, FTC Chairman Jon Leibowitz wrote that the new rule will not apply to devices sold for use on the market before January 1, 2021, or to devices marketed prior to July 20.
Leibowitz said the FTSC’s proposed rules will apply to medical devices that are sold or distributed within the United States, or that are manufactured and distributed outside of the United State, by companies that meet certain criteria, such as being “generally recognized as safe and effective.”
As an incentive for compliance, the rule is designed to incentivize companies to use the FTFSA data and data from their competitors to help them understand the applicabilities of the proposed new rule.
This means that companies will have a better understanding of the FTRSA rules for a variety of products and devices, including the new medical devices, and will have an easier time getting approved for use by the FMTs market, said Robert Ritter, chief information officer at CCC.
If approved, the new FTFSB will be effective from January 1 and will apply until January 20, 2021.
A number of health care devices that were not on the FTTA market when the new rules were adopted were reclassified to the FNTSA market.
The new FNTSB is expected be effective in 2019.
Read more: In a statement to Fortune, CCC said the new regulation will help ensure consumers have access to accurate information about the risks of medical devices they use, while providing clarity and transparency to manufacturers.
“The FTSS data and other information collected through the FFTSA will help consumers understand how their devices have been used and the risks they may be exposed to, while making it easier for manufacturers to make informed decisions about how to safely manufacture their products,” CCC wrote.
FTC’s guidance is the culmination of months of study and analysis that began in February 2018, and it has been implemented through a variety in the Federal Reserve’s regulatory process, including a new rulemaking review process.
In July, the Federal Deposit Insurance Corporation (FDIC) issued its own guidance on medical device health and safety data.
This guidance, which is also part of a rulemaking, will apply from January 20.