USFDA Medical Device Premarket Approval

Freyr specializes in guiding manufacturers through the United States Food and Drug Administration (US FDA)'s Pre-market Approval (PMA) process. With services ranging from compiling technical files to addressing deficiencies and liaising with the US FDA, Freyr ensures a smooth PMA application process, leading to successful outcomes for manufacturers seeking the US FDA's approval for their medical devices.

USFDA Medical Device Premarket Approval Overview

The USFDA Premarket Approval (PMA) process is one of the device registration pathways provided by the US FDA, primarily designed for FDA Class III medical devices. The FDA PMA approval process for Class III devices entails meticulous scientific and regulatory evaluations to assess the medical device's safety and efficacy, ensuring the highest standards are met prior to the market authorization.

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Who Should Submit a USFDA Medical Device Premarket Approval (PMA) Application?

Device manufacturers must submit a PMA application if the device:

Is novel.
Belongs to a high-risk class.
Cannot be found in the Product Classification Database.
Is not substantially equivalent (NSE) to Class I, II, or III devices.

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What is the Difference Between 510(k), PMA, and De-Novo Applications?

Device pertaining to Class III that supports human life or that presents a potential, unreasonable risk of illness or injury.
FDA PMA approval process requires clinical trials.
Requires onsite inspection before issuing PMA approval.
180 calendar days

Novel devices of Class I and II that do not have a valid predicate device.
Requires clinical study data.
No onsite audit before De-Novo approval.
150 calendar days.

FDA Class III devices that have substantial equivalency with the predicate device.
It does not require human testing.
No onsite audit before 510(k) clearance.
90 calendar days.

What are the Different FDA Premarket Approval Application Methods?

Manufacturers can opt for any of the following four (04) PMA application methods that would be best suited for their device:

Traditional PMA
Modular PMA
Product Development Protocol
Humanitarian Device Exemption

What are the Data Requirements for Medical Device Premarket Approval?

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.

What is the PMA Application Process?

What are the Post Approval Compliance Requirements for PMA?

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:

Post-approval requirements imposed in the FDA PMA approval order.
Post-approval changemanagement through timely submission of relevant PMA supplements
Submission for post-approval (annual) reports
21 CFR 803 regulations for Medical Device Reporting (MDR)
Post-market Surveillance Studiesas required by the USFDA in the PMA approval orders.

What is the USFDA fees for reviewing the PMA application?

The MDUFA user fees for original PMA and supplements is as below-

Application type	Fees for Fiscal Year 2023 (Oct 1^st, 2022 through September 30^th, 2023)
	Standard fee	Small business fee
PMA, PDP, PMR, BLA	$441,547	$110,387
Panel-Track Supplement	$353,238	$88,309
180-Day Supplement	$66,232	$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.