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Premarket Approval of Medical Devices

Overview

Overview

Premarket Approval (PMA) is one of the device registration pathways provided by the US FDA, majorly applicable for Class III devices. PMA applications undergo scrupulous scrutiny comprising of scientific and Regulatory reviews to evaluate the safety and efficacy of Class III devices.

Who Should Submit a PMA Application?

Device manufacturers must submit PMA application if the device:

  • is novel
  • belongs to high-risk class
  • cannot be found in the  Product Classification Database
  • is not substantially equivalent (NSE) to Class I, II, or III devices

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

Premarket Approval

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

De-Novo Classification

  • 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

510(k) Registration

  • 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 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 PMA Approval?

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 PMA approval order
  • Post-approval change management through timely submission of relevant PMA supplements
  • Submission for post-approval (annual) reports
  • 21 CFR 803 regulations for Medical Device Reporting (MDR)
  • Postmarket Surveillance Studies as 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 the Fiscal Year 2022 (Oct-1, 2021 through Sept-30, 2022)

Standard Fee

Small Business Fee

PMA, PDP, PMR, BLA

$374,858

$93,714

Panel-Track Supplement

$281,143

$70,286

180-Day Supplement

$56,229

$14,057

Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs and PMRs)

$13,120

$3,280

30-Day Notice

$5,998

$2,999

Real-Time Supplement

$26,240

$6,560

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.

Freyr Expertise and Advantages
Expertise

Freyr Expertise

  • Regulatory Due Diligence
  • Quality System Inspection Compliance
  • BIMO Audit Compliance
  • PMA Technical File Compilation
  • Publishing and Creation of eCopy
  • Validation and Submission of eCopy
  • Addresses RTA Response and Deficiencies
  • Liaising Services till Premarket Approval
  • Consultation for Deficiencies
  • Device Listing and Establishment Registration
  • Management of PMA Supplements and 30-day Notices
  • Annual Periodic Reporting Submissions
  • Mock Audits and 21 CFR 820 Training
Advantages

Freyr Advantages

  • Experience in handling many PMA submissions for diversified device categories
  • Expert team for premarket approval application as per the USFDA requirements
  • Additional support to handle PMA-related queries
  • On-time submission of deliverables
  • Up to date with the US FDA new amendments