What is FDA Premarket Approval (PMA) for Medical Devices?
Premarket Approval (PMA) is the FDA’s most rigorous regulatory pathway for medical devices. It is required for Class III devices, which include products that support or sustain human life, are implanted, or present potential unreasonable risk of illness or injury.
Unlike the 510(k) process, which relies on showing substantial equivalence to an existing device, PMA demands in-depth scientific evidence to demonstrate your device’s safety and effectiveness before it can be marketed in the US. PMA submissions undergo rigorous FDA review and demand significant time and resources to prepare.
Key Differences Between FDA PMA and 510(k) Pathways
The core distinction between a 510(k) and a PMA is the depth of evidence required and the level of FDA scrutiny. A 510(k) demonstrates that a device is substantially equivalent to a legally marketed predicate. A PMA requires a much more comprehensive scientific dossier, often including large-scale clinical investigations on human subjects.
The PMA has four review phases: acceptance, substantive, panel, and final review. During panel review, an advisory committee of independent experts evaluates the clinical data, safety, and effectiveness of the device and provides recommendations to the FDA. Manufacturers should be prepared to present clear, evidence-based responses to panel questions and may even need to provide expert witnesses or technical representatives.
FDA also conducts facility inspections as part of the PMA review process to assess quality management system compliance, including design controls, manufacturing processes, and documentation practices.
How to Know if Your Device Requires PMA
PMA is generally required for Class III and other high-risk devices without a predicate, with some exceptions. Certain Class III devices using established technology may qualify for the 510(k) pathway, which can be confirmed via the FDA’s Product Classification Database, CFR regulations, or if your device is substantially equivalent to a cleared 510(k) device.
For novel high-risk devices without predicates, PMA approval is mandatory. However, some novel devices that are low- to moderate-risk may be eligible for the De Novo process, a pathway that does not require PMA based on the low risk of the device. FDA Pre-Submission and Q-submission meetings can clarify your device’s classification and regulatory pathway when uncertain and are strongly recommended to avoid inaccurate submissions and clarifications upfront and get FDA’s thoughts on the data to be provided in the submission. These interaction meetings are free of charge.
How to prepare a successful FDA PMA
Compiling a successful PMA is a long-term project that requires a strategic roadmap. Here are the key steps in the project for a traditional PMA:
- Confirm FDA Device Classification: Verify your device is classified as Class III and requires PMA.
- Develop a Regulatory and Clinical Strategy: Map out the clinical study design needed to generate data that demonstrates device safety and effectiveness.
- Conduct Nonclinical Testing: Perform bench tests, biocompatibility assessments, and animal studies according to applicable FDA guidance and recognized standards.
- Execute Clinical Trials: Conduct well-controlled clinical investigations compliant with Good Clinical Practice (GCP).
- Prepare PMA Documentation: Compile all technical data, study reports, manufacturing details, labeling, and environmental assessments into the PMA submission.
- Submit the PMA to FDA: Electronically submit the complete PMA via the FDA’s Electronic Submission Gateway, including all required forms and user fees.
- Complete QMS audit: FDA will perform an inspection to ensure compliant processes, including design controls, process validation, and supplier management.
- Prepare for Advisory Panel: Be ready to provide expert testimony and field panel questions.
PMA approval is granted based on draft final labeling, with final printed labeling required before marketing. The FDA publicly announces approvals online with a summary of safety and effectiveness data online and quarterly in the Federal Register.
