The Center for Devices and Radiological Health at the FDA released the final guidance for the use of real-world evidence (RWE) in regulatory decision-making, which does not address the use of non-clinical data, adverse events reports, post-hoc analyses of clinical studies, or systematic literature reviews. The agency said that data from electronic data systems is insufficient as a sole source of data to support regulatory decisions, and that registry data may not prove sufficient for determinations of substantial equivalence. RWE can be used as an historical control data set and as a prior in a Bayesian clinical study, and to support a claim of clinical validity for a biomarker. The agency said the collection of real-world data for a legally marketed device may require an investigational device exemption, although this would not likely be the case for a device that is "used in the normal course of medical practice." The reliability of these sources of data hinges on several factors, including documentation as to the data elements to be collected, and the standards applied for data quality control. The agency noted that at least in one instance, an IDE was not required for the use of a registry in lieu of an independent study for compliance with a Section 522 order because the 522 order "was focused on device uses consistent with the [product] labeling."
The FDA issued a draft guidance providing policy clarification and premarket notification requirements pertaining to ultrasonic diathermy devices, noting that manufacturers who demonstrate compliance with two International Electrotechnical Commission standards (IEC 61689 and 60601-2-5) will not have to document compliance with two portions of Title 21 of the Code of Federal Regulations (§1010 and 1050.10). The agency recommended that predicate comparisons be provided in any 510(k)s for each treatment head and each acoustic frequency, and that biocompatibility can be demonstrated via existing literature or previous testing experience with the materials in question. Sponsors are advised to use AAMI-ANSI ES60601-1 and AAMI ANSI IEC 60601-1-2 to demonstrate electrical safety and electromagnetic compatibility, respectively. The FDA is taking comment through Oct. 30, 2017, under docket number FDA-2017-D-4764.
The FDA letter to health care providers pertaining to forced air thermal regulating systems stated that some providers and patients may be avoiding the use of these systems due to concerns regarding surgical site infections, but the agency said it has insufficient data to confirm such suspicions. The agency said it will continue to monitor its data for any possible association, but recommended the use of such systems "when clinically warranted."