The 510(k), IDE, Q-Sub, De Novo and PMA Programs for New (or Substantially Changed) Devices Marketed in the US
The US FDA has several programs by which a new medical
device can be marketed in the US. They are basically separated by the US FDA’s
Classification under 21 CFR 800-series, which in turn is guided primarily by risk
of use to the patient / end user. Class I
devices only have to meet basic regulatory requirements, e.g., General
Controls, the CGMPs, which for devices is 21 CFR 820.
Higher risk devices
must be reviewed by the FDA prior to commercial sale in the US. Class II devices generally are cleared by the
FDA through the 510(k) review process, which focuses on “substantial
equivalence” to a previously cleared and currently marketed “predicate device”. Rarely are clinical trials required for 510(k)s.
Clearance by the FDA allows the product to be marketed in the US.
If clinical trials are required for some Class II devices, they can sometimes by
addressed only by hospital IRBs (Institutional Review Boards). If the trial is necessary for new, novel
Indications for Use, then the FDA needs to be involved prior to the
clinicals. This is done by a Q-Submission,
to start a dialog with the FDA about the route to market for the proposed
device, and/or an IDE (Investigational Device Exemption) submission to the FDA to
allow the manufacture, shipment and clinical use of a somewhat experimental (investigational)
device.
The U.S. FDA mandates that the "Traditional" 510(k) submission
address 21 basic requirements. The
"Special" and "Abbreviated" 510(k)s must also address them,
but in different ways, e.g., ties to an existing 510(k) or certification to
adherence to consensus standard(s). In
addition, the FDA Task Force has identified several problem areas with the
existing medical device 510(k) process, leading to the growing push by the
Agency to broaden the usage of the 510(k) process, under “Breakthrough Devices”
(newer technology) or the STeP (new safety features) programs. Access to these
newer programs is through the Q-Sub.
If a device is higher risk. It won’t be listed in the 21 CFR 800-series. In such a case, it may be submitted to the
FDA under a request for consideration as De Novo (a lower risk class III, possibly Class II, device). If higher risk, definitely Class III, it will be
submitted under the PMA (Pre-Market Approval) process. Extensive clinical trials will be involved,
and the process can take a couple of years or more (the 510(k) process
generally is completed in about a half year).
Both the De Novo and PMA can benefit with initial dialog with the Agency via
the Q-Sub. Approval by the FDA allows
the product to be marketed in the US.
The De Novo pathway results in the product subsequently being addressed under
the 510(k) program. Class III devices
approved under the PMA program still require similar future products to also be
reviewed under the PMA program.
-- jel@jelincoln.com
