FDA Issues Final Guidance on Q-Submission Program
The FDA released final guidance on the forms of meetings and feedback devicemakers can request for various submissions under the agency’s Q-Submission program.
The guidance outlines the options available to drug sponsors seeking input from the FDA for investigational device exemption applications, premarket approval applications, humanitarian device exemption applications, De Novo requests, 510(k) submissions, clinical laboratory improvement amendments (CLIA) waivers, dual 510(k) and CLIA waiver by application submissions (duals), accessory classification requests and certain INDs and BLAs.
The agency said the guidance reflects agreed-upon changes related to scheduling pre-submission meetings and clarifies other elements of the Q-Submission program.
“Early interaction with FDA on planned nonclinical and clinical studies and careful consideration of FDA’s feedback may improve the quality of subsequent submissions, shorten total review times, and facilitate the development process for new devices,” the agency said.
Read the Q-Submission guidance here: www.fdanews.com/05-09-19-Q-Submission.pdf.
FDA Clears Up Performance Standards for Fluoroscopic Equipment
The FDA issued final guidance clarifying the performance standard requirements for certain fluoroscopic equipment, devices that use X-rays to capture real-time moving images of an object’s interior.
The agency decided to offer more clarification on fluoroscopy equipment performance standards based on input from a public meeting on reducing unnecessary radiation exposure from medical imaging.
The guidance doesn’t cover angiographic X-ray systems, as they are incapable of performing fluoroscopies.
Read the fluoroscopic equipment guidance here: www.fdanews.com/05-09-19-Fluoroscopic.pdf.
Natera Earns Breakthrough Device Designation for Tumor DNA Test
The FDA granted Natera breakthrough device designation for its Signatera product, a post-surgical test used for detecting and quantifying circulating tumor DNA (ctDNA) in a patient’s blood.
The test is tailored individually to patients previously diagnosed with certain cancers based on the unique mutations found in their tumors. It is meant to be used in combination with certain drugs.
Clinical studies showed that the test can identify residual disease in non-small cell lung, bladder, breast and colorectal cancer patients up to two years earlier than standard imaging.