Devices

CDRH Review Consistency/Predictability Big Item in Next User Fee Cycle

David McFarland

— 3 min read
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CDRH plans to improve medical device review consistency and predictability during the next user fee cycle (FY 2018-2022) through “enhanced supervisory oversight and routine quality audits,” according to just-posted minutes of an 8/15 user fee negotiation meeting that agreed to a draft commitment letter (see earlier story). FDA and the medical device industry agreed to a $400 million (67%) boost in fee revenue over the next five years beginning 10/1/2017.

FDA says it will establish a dedicated premarket quality management team, which will be responsible for quality and consistency during the premarket submission procession at CDRH, the minutes say. The agency also will improve the quality and consistency of “additional information” and “major deficiency” letters by providing the basis for deficiencies and appropriate supervisory review. With improved quality and consistency, average total time to decision for 510(k)s will be reduced to 108 days, and 290 days for PMAs in FY2022, which brings this in line with historical norms, it says.

FDA employee rewards and retention is a key outcome of the user fee agreement, according to the minutes. FDA will implement a more effective recruiting and hiring strategy, and it will aim to improve employee retention through incentive pay for managers funded by fees.

During recent negotiations, FDA requested $41.7 million for incentive pay to prevent anticipated attrition to other Centers in the event that legislation currently being considered by Congress is enacted that would permit FDA to increase pay for qualified scientific, technical, or professional positions that support the development, review, and regulation of medical products. FDA explained that other Centers have sufficient funding to offer higher salaries if such legislation were to be enacted, and that these Centers often seek the same scientific and technical expertise as CDRH. Industry, the minutes say, noted that it did not agree with the agency assumptions. “Furthermore, this request supplemented discussions in previous negotiation meetings between industry and FDA that focused on providing user fee funding to assist in retaining high performing managers; those discussions resulted in an agreement to provide $7.5 million in user fee funding to improve retention,” it says.

FDA and industry agreed that if Congress enacts the legislation to pay key device review personnel, they will work together to establish a plan that will address retaining key CDRH personnel currently funded in part by user fees, including additional appropriated funds or additional user fee funds, if warranted, the minutes say.

Other notable commitments under the user fee agreement include:

  •  FDA will implement information technology improvements that relate to new performance goals and reporting, including an industry dashboard that displays near real-time submission status;
  •  FDA and industry will participate in an independent assessment of the CDRH review process, including a more complete assessment of MDUFA III improvements and outcomes and an assessment of the effectiveness of the MDUFA IV programs;
  • FDA will ramp up to a performance goal for completion of 70% of de novo submissions within 150 days in FY2022;
  • FDA will strengthen the Third Party Premarket Review program by offering training to third party review entities, conducting audits, publishing performance reports of the entities and seeking authority to expand the scope of the program with the goal of eliminating routine re-review by FDA of third party reviews;
  • FDA will improve consistency in software reviews through establishment of a centralized digital health unit, streamline and align FDA review processes with software lifecycles, continue engagement in international harmonization efforts related to software review, and conduct other activities related to digital health;
  • FDA will develop internal expertise on patient engagement, support the increased use of patient preference information and patient reported outcomes (PROs) in premarket submissions, publish a PRO validation guidance, hold one or more public meetings, and clarify that PROs are voluntary and can be one mechanism for demonstrating safety and effectiveness or substantial equivalence;
  • FDA will provide funding for the National Evaluation System for Health Technology (NEST) to conduct a pilot to establish the value of real world evidence (RWE). It will also develop guidance and hold a public meeting on the use of RWE, including the context of medical device reporting for certain devices.
  • and, FDA committed to treating laboratory-developed tests no less favorably than other devices to which user fee performance goals apply and to report on corresponding key performance metrics.

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