Last November 2019 the Food and Drug Administration (FDA) published the regulatory activities planned for 2020.
In January 2020 FDA wished to attribute to the Class III the spinal spheres to use in the intervertebral merging procedures and the minimally manipulated allograft heart valves (MMM), unless approval from the market. Nevertheless FDA has established that the general and special regulatory controls, defined until now, are not sufficient to provide a reasonable safety and efficacy guarantee for these devices that, for now, remain excluded by Class III.
In February 2020 the publication of the regulation related to the Clinical Hold (clinical suspension of medical devices investigations) was planned.
By April 2020 medical device quality system regulation will be renewed. FDA’s review will replace the existing requirements with the specifics of the standard ISO 13485:2016, with the intention to reduce the compliance and registration charges to the manufacturers, harmonizing the International and American requirements.
By May 2020 changes to the “Medical Device Software Regulations” are provided. The Regulations will be reviewed to be made consistent to the “21st Century Cures Act”, which involves the exclusion of some softwares (with certain characteristics) from the category of medical devices.
By June 2020 FDA wants to finalize two of its current proposals: the first regulation will apply the restrictions on products for solar lamps, including lamps with ultraviolet rays (UV)), sunbeds and tanning boohts; the second regulation will establish formal procedures and criteria for de novo classification process, so to make it more transparent for the manufacturers that use it in the device marketing process.