The US Food and Drug Administration (FDA) have published draft guidance detailing updates to its least burdensome approach to regulating devices. By consolidating regulatory processes and removing or reducing unnecessary burdens associated with FDA regulatory activities, patients may have earlier and continued access to beneficial products.
Congress has directed the FDA to take a least burdensome approach to medical device pre-market evaluation, since the FDA Modernisation Act of 1997, in a way that eliminates unnecessary burdens that may delay the marketing of beneficial new products, while maintaining the statutory requirements for clearance and approval. This draft guidance is intended to accurately reflect Congress’ intent by describing the guiding principles and recommended approach for FDA staff and industry to facilitate consistent application of least burdensome principles.
The FDA defines “least burdensome” to be the “minimum amount of information necessary to adequately address a regulatory question or issue through the most efficient manner at the right time. This concept applies to all products that meet the statutory definition of a device and throughout the total product lifecycle (premarket and postmarket).”
The FDA state that applying least burdensome principles to device review in recent years has led to a reduction in review times and higher quality applications from industry. In September, the FDA announced plans to develop a less burdensome “alternative” pathway for 510(k) devices, which would be developed in 2018.
According to FDA, the least burdensome principles will apply to: Premarket submissions, including PMAs, premarket notifications (510(k)s, de novo requests, humanitarian device exemption (HDE) applications and investigational device exemption (IDE) applications; additional information and major deficiency letters; Q-submissions; informal or interactive inquiries regarding device development; panel review and recommendations; postmarket surveillance and post-approval studies; reclassifications and exemptions; guidance documents and their application; compliance-related interactions and regulation development.
To reduce the amount of information required from manufacturers, the guidance gives examples where companies can take advantage of less-burdensome sources of clinical data. For example, real world evidence and existing data and nonclinical data from bench testing and computer modelling.
UPDATE 2020: THE FINAL GUIDANCE HAS NOW BEEN PUBLISHED. ACCESS HERE.