The Pros and Cons of Standardized Testing

Independent organizations and FDA establish standardized test methods for materials and devices. The independent organizations (e.g., AAMI, ASTM, ISO, USP, etc.) create voluntary consensus standards. These may then become recognized by FDA, with some 1300 standards now found in the Recognized Consensus Standards database. For some of these standards, FDA includes a Rationale for Recognition statement with the curious language that the standard “is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.” Recognized standards may in turn be referenced in guidance documents. Once a standard is recognized, and certainly if it is mentioned in a guidance document, there is an expectation if not quite a requirement that a manufacturer will test their device to the cited standard as part of any pre-market submission. For example, biocompatibility testing references the FDA’s guidance on the use of ISO 10993-1. Similarly, for shelf life and sterility, FDA cites AAMI/ANSI/ISO 11607-1. FDA has also announced, but not yet implemented, a testing-based alternative to substantial equivalence by direct comparison. When device types and applicable performance criteria have been identified under this program, a manufacturer will be able to reach the market by meeting the FDA-identified performance criteria instead of by comparison to a predicate device. These performance criteria...
Source: MDDI - Category: Medical Devices Authors: Tags: Testing Source Type: news