USA Market
Premarket Approval (PMA)
Medical Device
IVD
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What is Premarket Approval (PMA)?
Premarket Approval (PMA) is one of the most rigorous and comprehensive regulatory pathways established by the U.S. Food and Drug Administration (FDA) for the approval of medical devices. It is required for certain high-risk medical devices that do not have a substantially equivalent predicate device on the market and therefore cannot go through the 510(k) clearance process.
Why is Premarket Approval (PMA) important?
PMA Consulting is critically important for medical device manufacturers because it is the regulatory pathway for high-risk devices with no substantially equivalent predicate, and it is often the only option for market entry.
Process Flow for Premarket Approval (PMA)
Device Classification and Determination
Regulatory Research
Preliminary Data Assessment
PMA Submission
Acceptance Review
Substantive Review
FDA Decision
Post Approval Activities
Labeling and Marketing
Regulatory Liaison
Continuous Improvement
How can we help in Premarket Approval (PMA)?
The CliniExperts’ professionals will:
Help streamline the process, potentially reducing time to market and development costs.
Help manufacturers navigate regulatory challenges and interactions with the FDA, which is essential for a successful PMA submission.
Help manufacturers maintain compliance with FDA regulations, ensuring ongoing market access and product availability.
With expertise in FDA regulations and requirements, we can increase the likelihood of a successful PMA approval by ensuring that submissions meet all necessary criteria.
Regulatory requirements for Premarket Approval (PMA)
Documents
A PMA application includes a wide range of documents and information, such as:
- Detailed device description and intended use
- Comprehensive scientific and clinical data to demonstrate safety and effectiveness
- Proposed labeling and instructions for use
- Information on the manufacturing process and quality control
- Risk assessments and mitigation strategies
- Clinical trial protocols and results
- Post-market surveillance plans
- Any other relevant documentation to support the application
Timeline
The timeline for a PMA submission and review process can be relatively long, often taking a year or more.
Regulatory Body
The regulatory body responsible for the PMA process is the U.S. Food and Drug Administration (FDA).
Fees
The annual fee for PMA is $441,547.
Validity
The PMA approval remains valid as long as the manufacturer maintains compliance with post-market requirements and quality control standards and reports adverse events and other safety concerns as required.
