We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » FDA Tightens Screws on Nonregulated Use of Molecular Diagnostic Tools
FDA Tightens Screws on Nonregulated Use of Molecular Diagnostic Tools
Devicemakers may use alternative approaches to dual boot designs in new submissions for molecular diagnostic tools that combine approved and unregulated functions if they demonstrate that the nonregulated functions don’t interfere with the approved ones, FDA final guidance says.