EASY MEDICAL DEVICES .

COM

Medical devices are classified into Class I, II, and III.

Preclinical:These regulations ensure that manufacturers follow certain

guidelines prior to obtaining premarket approval. They include establishment
registration (21 CFR part 807) and medical device listing (21 CFR part 807),
which require that manufacturers and importers register their establishments
and devices with the FDA

Clinical development:These regulations require that manufacturers complete

certain steps to support their application prior to obtaining approval for their
device. This includes authorizations from the FDA, submission of clinical data
to support claims made from the device, and data from a clinical study to
support their premarket approval process. These regulations include
premarket notification (21 CFR part 807 subpart E), premarket approval (21
CFR part 814), and investigational device exemption (21 CFR part 812)

Post-market approval:These regulations include advertising and promotion

guidelines, as well as medical device reporting (21 CFR part 803), which
includes the reporting of known device defects or incidents in which a device
may have caused considerable harm

Multi-phase: These regulations include requirements related to the controls

used by manufacturers throughout the product lifecycle—from designing to
servicing medical devices—as well as requirements for the informational
materials that accompany the device. Quality system regulation (21 CFR part
820) and labeling (21 CFR part 801) are included, as well