Record Device Approvals in 2018; New Regulatory Efforts Underway
CDRH approved a record 106 novel devices last year, eclipsing the 40-year record it set in 2017 when 99 such devices were approved. The agency also granted 112 breakthrough device designation requests since the start of the program in 4/2015, and in 2018 it approved or cleared nine breakthrough devices, according to an agency release.
FDA says that with its efforts to strengthen the clinical trial enterprise and leverage real world data, it is often “receiving clinical evidence more quickly and more efficiently and answering postmarket questions we would not have been able to easily address in the past. In 2019, we’ll continue to move forward with our plans to implement the National Evaluation System for Health Technology (NEST). We also plan to establish premarket pathways that foster innovations to enhance patient safety while continuing to build a more robust patient safety net in the U.S.”
Recently, CDRH finalized guidance for an alternative 510(k) pathway that encourages companies to demonstrate they meet safety and performance criteria developed by FDA based on the performance of more modern predicate devices. Later this year, the agency plans to establish safety and performance criteria for certain well-understood device types to allow manufacturers to demonstrate they meet the FDA’s criteria, including when it comes to product safety. “We will also take forward the other aspects of the 510(k) modernization we recently announced, including consideration of actions that might require new authority, such as making at least some older devices ineligible as predicates,” it says.
Additionally, the agency is planning this year to issue a proposed framework for the Safer Technologies Program, which will “consider how we could apply breakthrough device principles and features to products intended to treat or diagnose non-life-threatening diseases or conditions, but which offer substantial safety innovations that either reduce the occurrence of a serious adverse event or other safety issue; address a known device failure mode or common user error; or provide for significant safety advantages for users.”