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Premarket Approval (PMA) is one of the device registration pathways provided by the US FDA, majorly applicable for Class III devices. Medical device Premarket Approval (PMA) applications undergo scrupulous scrutiny comprising of scientific and Regulatory reviews to evaluate the safety and efficacy of Class III devices.
Device manufacturers must submit PMA application if the device:
Manufacturers can opt for any of the following four (04) PMA application methods that would be best suited for their device:
According to 21 CFR part 814, applicants must submit a duly filled CDRH application form, required undertakings, and a well-drafted PMA technical file to the US FDA. The technical file shall include the non-clinical and clinical data.
Non-clinical Data – It consists of data on microbiology, toxicology, immunology, biocompatibility, stress, wear, shelf life, and other laboratory or animal tests.
Clinical Data – It consists of data on study protocols, safety and effectiveness data, adverse reactions and complications, device failures, and replacements, patient information, patient complaints, tabulations of data from all individual subjects, results of statistical analyses, and any other information from the clinical investigations.
The devices approved under the PMA pathway shall comply with the post-marketing requirements set forth by the USFDA. The device must comply with the following:
The MDUFA user fees for original PMA and supplements is as below-
Application type |
Fees for Fiscal Year 2023 (Oct 1st, 2022 through September 30th, 2023) |
|
|
Standard fee |
Small business fee |
PMA, PDP, PMR, BLA |
$441,547 |
|
Panel-Track Supplement |
$353,238 |
$88,309 |
180-Day Supplement |
|
$16,558 |
Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs and PMRs) |
$15,454 |
$3,864 |
30-Day Notice |
$7,065 |
$3,532 |
Real-Time Supplement |
$30,908 |
$7,727 |
With expertise in handling PMA submissions, Freyr can assist in identifying and compiling the information and assist in the preparation and review of the application.
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