A 510(k) is a premarket submission made to the FDA to demonstrate that a medical device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device. The 510(k) regulatory pathway is a submission process that medical device manufacturers use to get clearance from the FDA to market an eligible product in the U.S. . The FDAs 510(k) clearance process allows medical devices to enter the U.S. market with no clinical trial requirement and no evidence that they are safe. The 510(k) process is designed to only let safe, effective medical devices onto the U.S. market, and into contact with American patients.

Some key points about the 510(k) process include:

• Substantial Equivalence: Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims.

• When to Submit a 510(k): A new 510(k) submission is required for changes or modifications to an existing device, where the modifications could significantly affect the safety or effectiveness of the device or the device is to be marketed for a new or different intended use.

• Types of 510(k) Submissions: There are two types of 510(k) submissions: Traditional and Abbreviated. The Abbreviated 510(k) program was developed as an alternative to the traditional path.

• When a 510(k) is Not Required: A 510(k) is not required if a company sells unfinished devices to another firm for further processing or sells components to be used in the assembling of devices by other firms.

• FDAs Efforts to Improve the 510(k) Process: In 2018, the FDA began looking into improving the 510(k) clearance pathway. However, it hasn’t removed it. The agency has sped up the review process “without compromising the agency’s high standards” .

Overall, the 510(k) process is an important regulatory pathway for medical device manufacturers to get clearance from the FDA to market their products in the U.S.