The US Food and Drug Administration (FDA) on Friday released a draft guidance document on recommendations for submitting 510(k)s to market ultrasound devices, final guidance in the form of a Q&A on the CDRH appeals process, final guidance on developing and responding to deficiencies, final guidance on display devices for diagnostic radiology and draft guidance on the classification and requirements for laser illuminated projectors.
The 60-page draft guidance offers recommendations for marketing ultrasound devices and is intended to replace guidance from 2008, with additional information for sponsors on deciding when a device modification to an ultrasound device can be made without the need for a new 510(k) submission.
Also, in a change from the 2008 document, the term "Output Display Standard" now refers only to the CDRH-recognized IEC standard, IEC 60601-2-37.
The draft retains the two-track approach from the 2008 document in which FDA's recommendations for the 510(k) submission depend on whether a device follows "Track 1" or "Track 3" (FDA says that "for historical reasons, there is no Track 2").
Track 1 recommendations are for devices that do not conform to the Output Display Standards in IEC 60601-2-37, while Track 3 recommendations are for devices that conform to the Output Display Standard in IEC 60601-2-37.
In addition, previous versions of this guidance "recommended that sponsors provide extensive documentation of individual transducer functions on the Indications for Use (IFU) form. Though this transducer function information should still be made available in the operator's manual, FDA is no longer recommending transducer function tables be included on the IFU form," the guidance adds.
The 8-page updated guidance from 2014 on appeals processes in CDRH features three questions and answers about 517A, which is the section of the Food, Drug, and Cosmetic Act (FD&C Act), which was added by section 603 of the FDA Safety and Innovation Act (FDASIA) of 2012, and amended by sections 3051 and 3058 of the 21st Century Cures Act of 2016.
The questions are: "What is a 'Significant Decision'?"; "What is a 'substantive summary'?" and "Who may request documentation of 517A decisions under section 517A of the FD&C Act, and how does this provision relate to requests under the Freedom of Information Act (FOIA)?"
Developing and Responding to Deficiencies
According to the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter, FDA committed to update this guidance to indicate that all "deficiency letters will include a statement of the basis for the deficiencies (e.g., a specific reference to applicable section(s) of a rule, final guidance, recognized standard unless the entire or most of document is applicable). In the instance when the deficiency cannot be traced in the manner above and relates to a scientific or regulatory issue pertinent to the determination, FDA will cite the specific scientific issue and the information to support its position. All deficiency letters will undergo supervisory review prior to issuance to ensure the deficiencies cited are relevant to a marketing authorization decision (e.g., 510(k) clearance, PMA approval, and De Novo classification)."
Display Device for Diagnostic Radiology
The 14-page guidance finalizes a draft from February 2016 to help industry in 510(k) submissions for display devices intended for use in diagnostic radiology.
Laser Illuminated Projectors
The guidance offers FDA's policy on certain laser illuminated projectors that comply with International Electrotechnical Commission (IEC) standards during laser product classification under the Electronic Product Radiation Control provisions of the FD&C Act.
Market Clearance of Diagnostic Ultrasound Systems and Transducers: Draft Guidance for Industry and FDA Staff
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
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)