Agency Imposes 2.5 Percent Increase in 2022 Premarket Application User Fees
Although the FY 2022 fees increase is less than half of last year’s increase, applying to the US Food and Drug Administration (FDA) for premarket review of medical devices will still be more expensive next year. On Aug. 2, the agency announced that it is raising premarket approval (PMA) user fees by 2.5 percent in FY 2022. How PMA User Fees Work FDA sets the fee rate for each type of submission based on a specified percentage of the standard fee for a premarket application. The Medical Device User Fee Amendments of 2017 (MDUFA IV) gives FDA the authority to collect user fees from the industry for certain medical device submissions to help pay for the agency’s review activities. The MDUFA IV requires the FDA to meet performance goals designed to improve the efficiency, speed and transparency of the PMA and 510(k) review process. In return, the medical technology industry provides the FDA $999.5 million in additional financial resources over a five-year period. In FY 2022, the $329,000 base fee and $4,978 establishment registration fee will be adjusted “using the same methodology as that for the total revenue inflation adjustment,” according to the agency. The good news is that the […]
Although the FY 2022 fees increase is less than half of last year’s increase, applying to the US Food and Drug Administration (FDA) for premarket review of medical devices will still be more expensive next year. On Aug. 2, the agency announced that it is raising premarket approval (PMA) user fees by 2.5 percent in FY 2022.
How PMA User Fees Work
FDA sets the fee rate for each type of submission based on a specified percentage of the standard fee for a premarket application. The Medical Device User Fee Amendments of 2017 (MDUFA IV) gives FDA the authority to collect user fees from the industry for certain medical device submissions to help pay for the agency’s review activities. The MDUFA IV requires the FDA to meet performance goals designed to improve the efficiency, speed and transparency of the PMA and 510(k) review process. In return, the medical technology industry provides the FDA $999.5 million in additional financial resources over a five-year period.
In FY 2022, the $329,000 base fee and $4,978 establishment registration fee will be adjusted “using the same methodology as that for the total revenue inflation adjustment,” according to the agency. The good news is that the resulting 2.5 percent adjustment for the year, which officially takes effect on Oct. 1, 2021, will be considerably less than the 7 percent increase in the user fee that the agency implemented in FY 2021.
Here are some of the key new FDA Emergency Use Authorizations (EUAs) and clearances announced in August:
New FDA EUAs & Approvals
| Manufacturer(s) | Product |
|---|---|
| Kwokman Diagnostics | EUA for Kwokman Diagnostics COVID-19 Home Collection Kit |
| Roche | Clearance for Ventana MMR RxDx immunohistochemistry panel as a companion diagnostic to select patients for treatment with GlaxoSmithKline’s newly cleared anti-PD-1 agent dostarlimab-gxly (Jemperli) for patients with previously treated, mismatch repair-deficient, or dMMR, solid cancers |
| Roche | EUA for RT-PCR-based Cobas SARS-CoV-2 nucleic acid test for use on the Cobas Liat system |
| STS Lab Holdco (Amazon subsidiary) | EUA for Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR Test |
| Cleveland Clinic | EUA for SelfCheck COVID-19 TaqPath Multiplex PCR test |
| Qiagen + Ellume | EUA for QiaReach SARS-CoV-2 Antigen Test |
| Pillar Biosciences | Premarket approval for OncoReveal Dx Lung and Colon Cancer Assay tissue-based companion diagnostic test for qualitative detection of somatic mutations in DNA from non-small cell lung cancer and colorectal cancer tissue samples |
| Thermo Fisher Scientific | EUA for COVID-19 Fast PCR Combo Kit 2.0 to detect SARS-CoV-2 nucleic acid in saliva samples |
| Thermo Fisher Scientific | EUA for TaqPath COVID-19 MS2 Combo Kit 2.0 PCR-based test |
| Access Bio | EUA for CareStart COVID-19 Antigen Home Test chromatographic, digital immunoassay |
| LumiraDx | EUA for SARS-CoV-2 Ab Test (total antibodies test) |
| Phase Scientific International | EUA for Indicaid COVID-19 Rapid Antigen Test |
| NYU Langone Health | 510(k) clearance for Genome PACT genetic test for solid tumors |
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