FDA primarily regulates products according to their intended use, not based on the technology used to generate the information. FDA takes risks of a new technology into account but for in vitro diagnostics this is a relatively small piece of the Agency’s concern. Typically the risk of the information provided is the main area of concern.
For example, the Agency views screening tests – tests used to broadly test asymptomatic populations for serious diseases — as much higher risk than a test that provides only prognostic information on already diagnosed patients. Likewise, any test that tells a doctor whether or which drug to give a patient is considered high risk as well as any test that diagnoses a serious condition. In addition, FDA typically considers any test that may prompt a woman to have an abortion as a high-risk test.
The intended use or indications for use of a product are the claims that the company wants to make about the product after approval.
Intended Use Statement:
An intended use statement includes a general description of the diseases or conditions that the device will diagnose, treat, prevent, cure, or mitigate, including a description, where appropriate, of the patient population for which the device is intended.
— 21 CFR § 812.2
For in vitro diagnostics, FDA also requires that the intended use specify what type of specimen that should be utilized in the assay and include as a very specific description of the population to be tested.
As an example, below is the intended use for the MammaPrint assay (cleared by FDA in 2007, 510(k)#: K062694).
MammaPrint® is a qualitative in vitro diagnostic test service, performed in a single laboratory, using the gene expression profile of fresh frozen breast cancer tissue samples to assess a patients' risk for distant metastasis. The test is performed for breast cancer patients who are less than 61 years old, with Stage I or Stage II disease, with tumor size ! 5.0 cm and who are lymph node negative. The MammaPrint® result is indicated for use by physicians as a prognostic marker only, along with other clinicopathological factors.
The disease or condition — breast cancer metastasis — is clearly stated in the intended use and the age of the patients to be tested is also stated. The age ranges listed are specific to the cohorts available for testing. In addition, the type of specimen — fresh frozen breast cancer tissue – is mentioned along with specifically the type of information to be provided — prognostic. Almost all in vitro diagnostic intended use statements also state that the information should be used along with other diagnostic and clinical information. Many also state that the information is for professional or prescription use.
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