US Medical Device Regulator to Improve PMA, IDE Processes

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) plans revisions to its Investigational Device Exemption process to improve clinical trial management for manufacturers and sponsors, and may also consider down-classifying some devices from Class III Premarket Approval registration requirements.

The CRDH’s plans were announced as part of the department’s 2014 Strategic Priorities, which also include “customer service” initiatives.

Regarding Investigational Device Exemption (IDE) process improvements, the CDRH has set a September 2014 deadline reduce the number of IDEs requiring more than two review cycles by 25% compared to FY 2013. Also by late September, the CDRH will notify sponsors of disapproved IDEs within 10 business days of reviewers’ decisions. By June 2015, the CDRH intends to cut in half the number of IDEs that require more than two review cycles.

The department has also targeted IDE review times: Median IDE review times will be cut by 25% by September 2014, and to 30 days by June 2015.

In addition, the CDRH intends to boost the number of early feasibility and first-in-human IDE studies in the US, which the FDA believes will improve US patient access to innovative medical devices and technologies. No firm numbers are given in terms of this planned increase, but the CDRH’s strategy document does list several steps to support this goal, including setting up a discrete program within its Office of Device Evaluation to oversee IDE processes and increased clinical trial-related training for CDRH staff.

Of even more interest—particularly to Class III manufacturers, no doubt—are CDRH plans to evaluate whether some devices registered under the FDA’s Premarket Approval (PMA) program for high-risk devices should be down-classified in order to expedite market authorization reviews for products that stand to benefit public health:

  • By December 2014: CDRH will review 50% of all device types currently requiring PMA registration to determine if any pre-market data requirements should be shifted to post-market requirements, and whether any down-classifications of device types are necessary
  • By June 2015: CDRH will review 75% of all PMA device types for potential down-classification
  • By December 2015: All PMA device types will be reviewed for potential down-classification purposes

Furthermore, the FDA may develop a separate market pathway for devices traditionally subject to PMA requirements that could address unmet public health needs.

FDA Investigational Device Exemption and Premarket Approval requirements can be significantly complex, expensive and time-consuming for manufacturers and sponsors. These steps, although preliminary, suggest a good-faith effort by US regulators to alleviate some unnecessary complications registrants have to undergo to commercialize high-risk devices. Fingers crossed.

Stewart Eisenhart

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