Glossary
510(k) Special
510(k) for changes to a manufacturer's own previously cleared device. Faster review (typically 30 days).
510(k) Abbreviated
510(k) relying on FDA guidance, special controls, or recognised consensus standards.
PMA
Premarket Approval — most stringent FDA device pathway, required for Class III devices. Requires valid scientific evidence of safety and effectiveness.
De Novo
Risk-based classification request for novel low-to-moderate risk devices with no predicate. Establishes a new device classification with special controls.
HDE
Humanitarian Device Exemption — for devices intended for diseases affecting fewer than 8,000 patients per year in the US.
IDE
Investigational Device Exemption — FDA authorisation to use a non-approved device in a clinical study (significant risk devices).
IND
Investigational New Drug application — submitted before a sponsor can ship an investigational drug for clinical trials.
NDA
New Drug Application — for approval of a new pharmaceutical product.
BLA
Biologics License Application — for approval of a biological product (vaccines, blood products, gene therapies, etc.).
ANDA
Abbreviated New Drug Application — for generic drug approval.
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