FDA Compliance
Premarket Approval (PMA)
Premarket Approval (PMA) is the most rigorous FDA pathway
Applies to: Class III device manufacturers
What Is Premarket Approval (PMA) and Why It Matters?
Premarket Approval (PMA) is the most rigorous FDA pathway, reserved for Class III medical devices 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 the 510(k) pathway, PMA does not rely on substantial equivalence to a predicate device. Instead, manufacturers must provide valid scientific evidence, typically including clinical trial data, to independently demonstrate that their device is safe and effective for its intended use. The PMA process is extensive, demanding, and highly scrutinized. Any deficiencies in the submitted evidence can result in significant delays or outright rejection.
How Can We Help?
At Certilance, we work alongside your team from the earliest stages, helping you design a regulatory strategy, structure your clinical and non-clinical evidence, and build a submission package that meets the FDA's rigorous standards. From pre-submission meetings with the FDA to compiling your technical sections and responding to panel reviews, our consultants ensure that every element of your PMA file is thorough, accurate, and positioned for approval.
FAQ
PMA — frequently asked questions
Yes. Medical devices must obtain FDA clearance or approval before being marketed in the United States. The pathway depends on device classification, intended use, and risk profile.
The U.S. Food and Drug Administration (FDA) regulates devices through:
- 510(k) premarket notification
- De Novo classification
- Premarket Approval (PMA)
Each pathway has different evidence, testing, and review requirements.
No. CE marking and FDA approval are completely separate regulatory systems. Compliance with one does not grant access to the other market.
FDA does not formally certify ISO standards. However, an ISO 13485-aligned quality system strongly supports FDA Quality System Regulation (QSR) compliance and significantly reduces inspection findings.
Certilance helps manufacturers prepare documentation, quality systems, and regulatory evidence aligned with FDA expectations, ensuring submissions and inspections proceed efficiently.
FDA timelines vary by pathway (510(k), De Novo, or PMA) and submission quality. While FDA review periods are defined, real-world timelines are often extended due to deficiency letters, additional data requests, or design control gaps.
Early regulatory alignment significantly reduces delays.
FDA-related costs depend on:
- Regulatory pathway
- Testing and validation requirements
- Submission complexity
- FDA user fees (where applicable)
Well-structured submissions reduce review cycles and overall cost exposure.
FDA Compliance
Related services
PMA
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