First, a basic understanding of the 510 (K): A 510(k) is essentially a premarket submission that the medical device manufacturer makes to FDA to show that the device that the manufacturer intends to market is at least as safe and effective, or to use FDA parlance, Substantially Equivalent (SE), to a legally marketed device that is not subject to PMA. A legally marketed device is described as belonging to either of these categories: a) a device that was legally marketed prior to May 28, 1976 (pre amendments device), for which a PMA is not required; b) a device whose classification has been changed from Class III to Class II or I, or c) a device which, through the use of the 510(k) process, has been found to be SE.
The way of going about it
How do device manufacturers go about the process of preparation and clearance? They can support their substantial equivalency claims by comparing their device to one or more similar legally marketed devices.
A few good practices
Good practices on 510(K) Preparation and Clearance are mostly what are derived by experience. They are thus more of rule of thumb than any cogent law. A few good practices at preparation and clearance that companies can implement to get hassle-free approval include the following:
• Be clear about the regulatory pathway that the device needs to fulfill. Many companies make the mistake of giving too many uses from a device, which is likely to act as a stumbling block to the regulatory process;
• FDA guidelines are your Bible! Follow every step of its Guidance Document scrupulously and painstakingly.
• Follow extant standards, and keep the eyes and ears open to upcoming, amended standards.
• Have a qualified, well experienced regulatory professional to take care of the company’s 510(K) Preparation and Clearance work