In Vitro Diagnostics
Under the HHS Commitment Letter, FDA is studying and pursuing a variety of approaches to clarify its regulatory requirements and reduce regulatory burdens. As part of this effort, FDA published three new guidance documents specifically called for in the HHS Commitment Letter:
- Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA.
- Draft Guidance for Industry and FDA Staff - Assay Migration Studies for In Vitro Diagnostic Devices.
- Guidance for Industry and FDA Staff - Recommendations for Anti-Nuclear Antibody (ANA) Test System Premarket (510(k)) Submissions.