CDRH: Record novel device authorizations, MDUFA goals on track in FY2023

The US Food and Drug Administration’s (FDA) medical device center said 2023 was a “banner year” for novel devices, and it expects to meet its goals for the year set by the Medical Device User Fee Amendments (MDUFA V).

Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), called 2023 a transformative year in a new annual report on the center’s achievements while also touting its work to meet MDUFA V goals. Under the user fee agreement, the agency agreed to launch a Total Product Life Cycle Advisory Program (TAP) pilot, which has expanded over the past year.

The medtech industry has long complained about reimbursement challenges for innovative medical devices after they reach the market. One of the goals of the TAP pilot, which came about as a result of the MDUFA V negotiations, is to serve as a forum where external stakeholders, including patients and insurers, can be engaged with breakthrough device makers earlier in the product development cycle.

While industry initially opposed the program, it agreed to try it out as a pilot program that would gradually be expanded to FDA’s various Offices of Health Technologies (OHT).

Since the pilot was launched, FDA has enrolled 15 Breakthrough-designated devices from the Office of Cardiovascular Devices (OHT2) and then expanded it to 10 more devices in the Office of Neurological and Physical Medicine Devices (OHT5). The agency says it plans to enroll up to 60 products from OHT2 and OHT5 this year.

“TAP is already working to foster innovation across the medical device industry by improving the predictability and reducing the time and cost of the ‘valley of death’ from concept to commercialization,” said Shuren. “We believe this pilot has the potential to ultimately improve patient access to safe, high-quality, transformative, and even life-saving medical devices and spur greater investment in innovative device development while staying aligned with the FDA’s rigorous standards for device safety and effectiveness.”

FDA spokesperson Kristina Wieghmink told Focus that while CDRH helps facilitate discussions between TAP participants and non-FDA stakeholders if they are asked to do so, the center does not design, establish, convene, or run the discussions.

“TAP participants have requested strategic input in areas including patient partnership, clinical evidence for provider adoption, and payer evidence expectations,” she added.

The MDUFA V agreement lists other process improvements that FDA is required to meet, including more patient and science engagement with industry, more international regulatory harmonization, third-party review, and guidance development. Despite taking on a greater workload over the past year, CDRH said it is confident it will meet its MDUFA V metrics, which will be reported in March.

“FY2023 saw the highest volume of MDUFA premarket submissions in at least a decade,” said FDA. “However, even in the presence of this increased workload, CDRH is on track to meet its FY2023 review goals.”

FDA noted it had well-exceeded its MDUFA V requirement to provide feedback to premarket applications within 70 calendar days or five days prior to a meeting with the agency 75% of the time, and filled all of the 141 CDRH positions it agreed to fill in FY2023, and is on track to meet its FY2024 hiring target. It has also updated its electronic Submission Template And Resource (eSTAR) system for 510(k) submissions, expanded its CDRH Customer Collaboration Portal (CDRH Portal) to allow sponsors to track presubmission information, updated guidance on deficiency letters, fully launched its Accreditation Scheme for Conformity Assessment (ASCA) program, and published a draft international harmonization strategic plan.

Shuren highlighted several other factors he considered successes, including addressing medical device shortages, harmonizing regulations across regulatory regimes, and allowing a record number of novel devices in the market.

Shuren also noted that since the public health emergency (PHE) expired in May 2023, more than 40 emergency use authorized (EUA) devices have transitioned to traditional marketing authorizations. Wieghmink noted that more than 900 EUAs were granted during the COVID-19 pandemic, and while the agency could not provide information about current submissions, it has seen an increase in the number of EUA medical devices that have received traditional marketing authorizations.

"[T]his was a banner year for the center, authorizing the highest number of novel devices on record (excluding EUAs) in CDRH’s more than 40-year history,” said Shuren. “One example includes our clearance of the first over-the-counter fentanyl test, which the agency cleared in just 16 days – a testament to our work to further advance bringing health care into the home setting.”

CDRH said that 124 novel devices received marketing authorization last year, 167 submissions were given breakthrough device designation, and 29 submissions designated as breakthrough devices were given marketing authorization. The agency added that it has seen a five-fold increase in the number of novel devices given marketing authorization since 2009.

Wieghmink said a wide variety of factors have contributed to the record number of novel devices that have been allowed on the market. In particular, she noted part of the success can be attributed to the agency’s plans announced in December 2021 to redouble efforts to get back to normal review times.

CDRH also attributed part of its success in getting more products to market to the more than 150 regulatory science tools (RST) it has developed over the years that sponsors can use in their premarket applications. The center added that it has begun tracking use of the tools and noted that in one case a tool was used in more than 450 premarket submissions across its eight OHTs.

2023 CDRH annual report

CDRH: Record novel device authorizations, MDUFA goals on track in FY2023

Related topics

Recommended content

Welcome to the new RAPS Digital Experience