FDA Premarket Approval (PMA)
FDA Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. PMA is required for Class III devices that support or sustain human life or present a potential unreasonable risk of illness or injury.
About FDA Premarket Approval (PMA)
FDA 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective — that is, substantially equivalent — to a legally marketed device that is not subject to Premarket Approval (PMA). 510(k) Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims.
Premarket Approval (PMA) is the FDA process for reviewing Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.
Unlike 510(k), which requires only substantial equivalence to a predicate device, PMA requires valid scientific evidence demonstrating that the device is both safe and effective for its intended use. The PMA process is the most rigorous type of device marketing application.
Liberty Management Group can assist you with FDA 510(k) clearance for your medical device. Our experienced consultants provide guidance from predicate device selection through establishment registration and listing. LMG also provides US Agent service for foreign medical device manufacturers.
The technical sections containing data and information should allow FDA to determine whether to approve or disapprove the application. These sections are usually divided into non-clinical laboratory studies and clinical investigations.
Non-clinical Laboratory Studies’ Section:
Non-clinical laboratory studies’ section includes information on microbiology, toxicology, immunology, biocompatibility, stress, wear, shelf life, and other laboratory or animal tests. Non-clinical studies for safety evaluation must be conducted in compliance with 21CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies).
Clinical Investigations’ Section:
Clinical investigations’ section includes 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. Any investigation conducted under an Investigational Device Exemption (IDE) must be identified as such.
FDA regulations provide 180 days to review the PMA and make a determination. In reality, the review time is normally longer.
LMG will assist you throughout the PMA process, our services include
- Assist you in developing study protocols
- Prepare your manufacturing facility for FDA plant inspection
- Assist you in preparing the submission
- Prepare you for participate in FDA review meetings
- Participate in FDA review meeting ,if needed
Device Classification
Identification of your device's FDA product code, device class, and applicable regulation — the starting point for all 510(k) pathway decisions.
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Predicate Device Analysis
Identification and analysis of suitable predicate devices for your 510(k) — the foundation of substantial equivalence and the most critical element of a successful submission.
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510(k) Submission
Complete preparation of your Traditional, Abbreviated, or Special 510(k) submission — including Device Description, Intended Use, Substantial Equivalence, Performance Testing, and Labeling sections.
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FDA Interaction Support
Preparation for pre-submission (Q-Sub) meetings with FDA, responses to Additional Information (AI) requests, and guidance throughout the FDA review process.
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Frequently Asked Questions
What is the difference between PMA and 510(k)?
Which medical devices require PMA?
How long does FDA 510(k) review take?
Does LMG provide 510(k) consulting?
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Contact LMG to discuss your medical device regulatory pathway and submission requirements.
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