Regulatory Affairs
FDA Premarket Approval (PMA)
The most rigorous FDA pathway, for high-risk Class III devices.
What It Is
Premarket Approval (PMA) is FDA’s most stringent device pathway, required for Class III devices that support or sustain life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. A PMA must stand on its own scientific and clinical evidence of safety and effectiveness rather than on equivalence to a predicate, and frequently relies on data from an IDE clinical study.
When You Need It
You need a PMA when your device is classified Class III and no down-classification path applies. This includes many implantable, life-supporting, and high-risk diagnostic devices. PMA programs usually pair with an Investigational Device Exemption (IDE) to generate the required clinical data.
What We Do
We support PMA strategy, modular PMA reviews, and the assembly of the nonclinical and clinical evidence package. We coordinate the manufacturing, sterilization, biocompatibility, and shelf-life sections, support the IDE and clinical strategy, and prepare for the PMA manufacturing facility inspection — an area where our hands-on operations experience is directly relevant.
We Live It, Not Just Advise It
A PMA includes a pre-approval inspection of your manufacturing and quality systems. We host FDA and client audits of our own FDA-registered operation on a regular basis — we know exactly what an investigator looks for on the floor, because they look for it in ours. That is a fundamentally different preparation than a consultant who has only read about it.
Frequently Asked Questions
What is the difference between a PMA and a 510(k)?
A 510(k) demonstrates substantial equivalence to an existing predicate device; a PMA must independently prove safety and effectiveness, almost always with clinical data. PMA is reserved for high-risk Class III devices and is significantly more time- and evidence-intensive.
Does a PMA require a clinical trial?
Most PMAs require valid scientific evidence that includes clinical data, typically generated under an IDE-approved study. We help design the clinical and regulatory strategy together so the evidence you collect is the evidence the PMA needs.
What is a modular PMA?
A modular PMA lets you submit sections (modules) of the application to FDA as they are completed rather than all at once, getting feedback along the way. It can de-risk a long program by surfacing FDA concerns earlier.
Ready to Talk Through Your PMA Project?
Tell us where you are in the process. We respond within one business day.
Request a ConsultThe Boulder BioMed Family
One campus, one quality system. We manufacture, sterilize, and test medical devices in-house — so our regulatory and quality work is grounded in operations, not theory.