FDA has issued 13 new and updated guidance documents for medical devices

The US Food and Drug Administration (FDA) published 3 device-specific guidance documents on 29th September that provide recommendations for 510(k) submissions for Ultrasound Systems (draft document) and Display Devices for Diagnostic Radiology Devices (final document), as well as classification and requirements for Laser Illuminated Projectors (draft document):  

Market Clearance of Diagnostic Ultrasound Systems and Transducers: Draft Guidance for Industry and FDA Staff

Display Devices for Diagnostic Radiology Guidance for Industry and Food and Drug Administration Staff

Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57)

Four guidance documents were issued on user fees, Premarket Notification Applications (510(k)s), Premarket Approval Applications (PMAs) and Device Biologics License Applications, De Novo Classification requests and 513(g) Requests for Information (RFIs). Each guidance document indicates when the fees are applicable and what the exceptions and consequences of not paying might be.  Links to these documents are provided below:

User Fees and Refunds for Premarket Notification Submissions (510(k)s)

User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications

User Fees and Refunds for De Novo Classification Requests

User Fees for 513(g) Requests for Information

Three other guidance documents outline the actions that FDA and manufacturers can take with regard to 510(k) submissions, PMAs and De Novo requests, and how those actions impact FDA’s review clock and Medical Device User Fee Amendments (MDUFA) goals:

FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals

FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals

FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals

Another 3 guidance documents include a Q&A document on the Centre for Devices and Radiological Health’s (CDRH) appeal process, a guidance document on developing and responding to deficiencies, as well as a guidance document on requests for feedback on medical device submissions:

Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A

Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff