The principles provided in the FDA’s Least Burdensome Provisions Guidance offer useful tools to assess evidence requirements and information on how to effectively navigate the regulatory review process in the United States.
In late April 2022, the long-awaited Medical Device Coordination Group (MDCG) guidance on borderline devices under the Medical Device Regulation (MDR) was published. In this newly-released guidance, the MDCG essentially replaces the borderline guidance in MEDDEV 2.1/3 Rev3, originally written for the EU Medical Device Directive (MDD).
In November 2021, the Medicare Coverage of Innovative Technology (MCIT) repeal was published in the Federal Register. This decision left start-up MedTech companies wondering if a U.S. Food and Drug Administration (FDA) Breakthrough designation would have advantages over traditional pathways and assist with the medical device reimbursement process.