The FDA guidance issued earlier this year on how it will use real-world evidence to make regulatory decisions is generally helpful but relies too heavily on registries and the pre-submission process and needs to be clarified, industry groups said in public comments.
In its comments, the Advanced Medical Technology Association said it is “optimistic about the potential benefits” of real-world evidence (RWE) and real-world data (RWD). However, it said the FDA needs to provide more information about how the agency will use the information.
In particular, it said the scope of the guidance should be expanded to include additional sources of RWE beyond registry data, clarify application of the guidance to Class II devices that are not subject to a registry, and explain how real-world evidence can support regulatory decision-making for Class II products in the pre-market phase of development.
The FDA issued guidance on July 26 on how it plans to evaluate RWE and RWD to determine when it could be used to support regulatory decisions for medical devices (). The public comment period for the guidance closed Oct. 25.
AdvaMed also said the FDA should provide additional examples of how the agency can use RWE to bring products to market faster, better explain how it will weigh various data sources used to make regulatory decisions and clarify the application of informed consent to avoid conflating the use of RWE and RWD with the collection of research data when studying an investigational device.
In its comments, the Medical Imaging & Technology Alliance (MITA) urged the FDA to clarify that use of RWE and RWD is voluntary. The group also said the draft guidance should provide criteria for using RWE for regulatory decision-making.
In addition, the guidance asks manufacturers to notify the FDA through the pre-submission process when considering whether to use RWE to meet data requirements. MITA expressed several concerns about this requirement.
In particular, the guidance indicates that RWE can be used for a variety of regulatory decisions, including post-market controls. “MITA strongly believes that the use of the pre-submission process to discuss the use of RWE for post-market uses is inappropriate,” the group said. It asked the FDA to provide another way to discuss RWE in the post-market process.
Economic Impact, Study Design Methods
The Small Biotechnology Business Coalition said the evidentiary burden placed on diagnostics developers is often comparable to that placed on drug companies, even though revenues for diagnostics developers are typically much smaller.
“Use of RWE in lieu of clinical trials has enormous potential to lower the barriers to diagnostics development without necessarily compromising safety or efficiency,” the group said. “The draft guidance should elaborate on this point and stipulate that economic cost-benefit analysis should be given significant weight by the FDA when deciding whether to accept RWE in lieu of prospective data or traditional clinical trials.”
The Biotechnology Innovation Organization (BIO) asked the FDA to provide guidance on “good study design methods, conduct or statistical methodology.” In addition, BIO said the FDA should specify that there should be different types of studies required to inform different types of decisions, and it should provide additional clarity regarding how source data standards can be achieved while adhering to current privacy standards.
The 510(k) Coalition said the guidance should clarify the requirements for using different types of RWE and RWD. Most of the examples seem to focus on clinical-type data and do not consider data from sources such as engineering analysis and bench testing, which are often highly valuable in the device context, it said.