Design History File vs. 510(k) vs. Technical File: What Do Medical Device Developers Need to Know?

There are so many different technical terms, documents, and acronyms you need to know working in the medical device field. There are three types of files specifically that cause a great deal of confusion: the design history file, 510(k) submission, and the technical file. As with any kind of files in medical device development, these require a lot of effort. However, if you have good background knowledge, I think you will find there are similarities between each. Design History File The design history file is an FDA term described in 21 CFR Part 820.30, which talks about design controls and how they must be kept in a design history file (DHF). This is simply the collection of documents from the design and development process. Per FDA, “Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plans and the requirements of this part.” Until recently, a DHF was technically only a requirement defined by FDA. ISO 13485:2003 made no direct mentioned of a DHF, or something similar. However, the updated ISO 13485:2016 now specifies the need to establish “design and development files”. The DHF now has more emphasis because it is acknowledged as a key file containing design control documentation. This is important because your design controls are your records demonstrating your product is safe. Maintaining a DHF is mo...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news