FDA Medical Device Regulations
FDA medical device regulations cover the entire lifecycle of medical devices: classification, premarket review, manufacturing quality, labeling, postmarket surveillance, and adverse event reporting. The regulatory pathway depends on the device's risk classification (Class I, II, or III), with higher-risk devices requiring more rigorous review.
Key Points
Devices are classified into three classes based on risk: Class I (low), Class II (moderate), Class III (high)
Most Class II devices require 510(k) premarket notification (substantial equivalence to a predicate device)
Class III devices require Premarket Approval (PMA) with clinical data
The Quality System Regulation (QSR) requires design controls, production controls, and CAPA systems
Medical Device Reporting (MDR) requires manufacturers to report deaths, serious injuries, and malfunctions
All device establishments must register with FDA and list their devices annually
Key Areas
Classification
Device classes, reclassification procedures
Premarket Approval
PMA applications, supplements, clinical data
Quality System (QSR)
Design controls, production, CAPA, records, management responsibility
Reporting & Registration
MDR reporting, establishment registration, listing
Key Provisions
Design Controls
Requires documented design and development planning, inputs, outputs, review, verification, validation, and transfer. The foundation of device quality.
MDR Reporting: Manufacturers
Manufacturers must report to FDA when they become aware of information reasonably suggesting a device caused or contributed to a death or serious injury.
PMA Application Content
Defines what must be included in a Premarket Approval application, including clinical investigation data.