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