Posted: 25 Feb 2020 08:30 PM PST
By Jeffrey N. Gibbs & Véronique Li, Senior Medical Device Regulation Expert —
CDRH has made commitments to stakeholders about completing reviews in a timely manner. For the fiscal year (FY) 2019, though, FDA acknowledged that it missed review-time goals for evaluating product recalls and Medical Device Reports (MDRs). FDA reviewed and classified recalls in a timely fashion 84% of the time in FY 2019, just one percent shy of its 85% goal. (They do not define “timely fashion”.) For Blue Code MDRs, although its goal had been to review 90% of them within 72 hours of receipt, FDA did so 88% of the time in FY 2019. (While these may not seem like major deviations, we have seen FDA be strict when sponsors barely miss their study endpoint.)
In addition to these missed goals, only 21 quality-related warning letters were issued to device manufacturers last year. CDRH does not have any goals – or at least public ones – for issuing warning letters, but it does mark the third year in a row of record low quality-related warning letters issued. This is down from a recent high of 121 – or about 80% – in 2015.
FDA attributes these drops to the CDRH reorganization, which did away with the Office of Compliance, the Office of Surveillance and Biometrics, and the Office of Device Evaluation. In their place, the Office of Product Evaluation and Quality “super office”, which centralized much of the device review into one office, came to be, and with it, many staff acquired new responsibilities. FDA blamed the missed goals on the inexperience of staff in these roles.
However, that doesn’t explain other curious instances we have seen where FDA has operated out of the norm. In the last six months, FDA flat out declined a pre-submission meeting. The company received a meeting rejection nearly five months after submitting the pre-submission (and far exceeding the 60-75 days timeframe for sending feedback or scheduling a meeting).
In another example, FDA has yet to provide a revised version of meeting minutes within 30 days of acceptance, as would be consistent and expected based on the pre-submission guidance. The lead reviewer in this case cited “a large backlog of files.”
We have also seen a recent instance where the review team stayed consistent in discussions with the company yet missed its 510(k) goal. Despite a high level of engagement from the company over the last year and including during the review of the submission, FDA missed the MDUFA performance goal for a 510(k) of 90 days. On February 24, 2020, 111 days after the submission was received and three weeks after the 90 days performance goal, the company finally received FDA’s decision.
With respect to administrative tasks, we have noticed extended delays over posting decision summaries to the De Novo database, which is supposed to be updated weekly. It has been nearly a year since several De Novos were authorized with no decision summary posted. When pressed, FDA has not identified unusual circumstances contributing to these delays. Nor has it committed to posting the documents anytime soon. In one particular instance, eleven months elapsed from the time of the granting of the De Novo before a decision summary was posted to the public database.
These examples are idiosyncratic and don’t make a trend. Even so, CDRH’s willingness to miss deadlines in multiple situations starts to form a troubling pattern.
CDRH certainly has many challenging tasks and projects. Still, the seemingly increased tendency to miss deadlines is troubling. While the reorganization might explain inconsistent reviews, it cannot explain all these failures to meet expectations.
CDRH has made commitments to stakeholders about completing reviews in a timely manner. For the fiscal year (FY) 2019, though, FDA acknowledged that it missed review-time goals for evaluating product recalls and Medical Device Reports (MDRs). FDA reviewed and classified recalls in a timely fashion 84% of the time in FY 2019, just one percent shy of its 85% goal. (They do not define “timely fashion”.) For Blue Code MDRs, although its goal had been to review 90% of them within 72 hours of receipt, FDA did so 88% of the time in FY 2019. (While these may not seem like major deviations, we have seen FDA be strict when sponsors barely miss their study endpoint.)
In addition to these missed goals, only 21 quality-related warning letters were issued to device manufacturers last year. CDRH does not have any goals – or at least public ones – for issuing warning letters, but it does mark the third year in a row of record low quality-related warning letters issued. This is down from a recent high of 121 – or about 80% – in 2015.
FDA attributes these drops to the CDRH reorganization, which did away with the Office of Compliance, the Office of Surveillance and Biometrics, and the Office of Device Evaluation. In their place, the Office of Product Evaluation and Quality “super office”, which centralized much of the device review into one office, came to be, and with it, many staff acquired new responsibilities. FDA blamed the missed goals on the inexperience of staff in these roles.
However, that doesn’t explain other curious instances we have seen where FDA has operated out of the norm. In the last six months, FDA flat out declined a pre-submission meeting. The company received a meeting rejection nearly five months after submitting the pre-submission (and far exceeding the 60-75 days timeframe for sending feedback or scheduling a meeting).
In another example, FDA has yet to provide a revised version of meeting minutes within 30 days of acceptance, as would be consistent and expected based on the pre-submission guidance. The lead reviewer in this case cited “a large backlog of files.”
We have also seen a recent instance where the review team stayed consistent in discussions with the company yet missed its 510(k) goal. Despite a high level of engagement from the company over the last year and including during the review of the submission, FDA missed the MDUFA performance goal for a 510(k) of 90 days. On February 24, 2020, 111 days after the submission was received and three weeks after the 90 days performance goal, the company finally received FDA’s decision.
With respect to administrative tasks, we have noticed extended delays over posting decision summaries to the De Novo database, which is supposed to be updated weekly. It has been nearly a year since several De Novos were authorized with no decision summary posted. When pressed, FDA has not identified unusual circumstances contributing to these delays. Nor has it committed to posting the documents anytime soon. In one particular instance, eleven months elapsed from the time of the granting of the De Novo before a decision summary was posted to the public database.
These examples are idiosyncratic and don’t make a trend. Even so, CDRH’s willingness to miss deadlines in multiple situations starts to form a troubling pattern.
CDRH certainly has many challenging tasks and projects. Still, the seemingly increased tendency to miss deadlines is troubling. While the reorganization might explain inconsistent reviews, it cannot explain all these failures to meet expectations.
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