5. Big shifts in regulatory and reimbursementThis year saw the FDA issuing a slew of emergency use authorizations (EUAs) amid the desperate need for medtech to better manage the pandemic and save lives. Time will tell whether the easing of regulation will stick around as the pandemic crisis eases and the new Biden administration seeks to fulfil its own priorities.
In July, the agency released the second list of Class II devices it has exempted from 510(k) clearance requirements, as required by the 21st Century Cures Act. Less comprehensive than its first lists, released in 2017, this final order includes certain reproductive, orthopedic, rehabilitative exercise and therapeutic massage technologies.
The pandemic and a lack of notified bodies needed to review new and updated applications led the European Commission to delay its Medical Device Regulation (MDR) by one year to May 26, 2021. The commission, however, is still intent on requiring manufacturers of in vitro devices to comply with new regulations governing those devices, set to go into effect May 26, 2022.
On the reimbursement side, good news for medical device companies came as CMS agreed to cover ‘breakthrough’ medical devices.
This news was followed by more than a dozen breakthrough device designations in the second half of 2020. – NC