Companies have several avenues available to share their input on and help shape MedTech regulation. At the 2023 MedTech Regulatory Intelligence Summit, former FDA CDRH member Steven Silverman, and Patterson Shafer, strategic advisor to FDA, offered guidance on how to establish credibility with FDA and the most effective ways to make your voice heard.
The draft guidance includes regulatory context in which use of real world evidence (RWE) may be appropriate, general considerations for the use of RWE, guidance on assessing data relevance and reliability, and considerations for methodologies for collection and analysis of real world data (RWD) to generate RWE.
The FDA is seeking representatives to join the Genetic Metabolic Advisory Committee, which will advise the agency on products used for the diagnosis, prevention or treatment of genetic metabolic diseases under the purview of the Division of Rare Diseases and Medical Genetics.
On November 27, the FDA announced that it is no longer a member of the Global Harmonization Working Party (GHWP) but will continue its outreach to global partners and its efforts to ensure alignment of medical device international harmonization by working with the International Medical Device Regulators Forum (IMDRF).
The guidance provides a framework that manufacturers can use to show that physics-based or mechanistic computational models used to support regulatory submissions are credible.
The goal of the collaboration is to optimize the benefits of PCCPs by supporting predictability and harmonizing regulatory considerations across jurisdictions, and ultimately, put safe and effective advancements in the hands of healthcare providers and users faster.
The committee will advise the Commissioner of Food and Drugs on issues related to Digital Health Technologies (DHTs), and FDA policies and regulations about these technologies, providing relevant expertise and perspective to improve the FDA’s understanding of the benefits, risks and clinical outcomes associated with use of DHTs.
Change control plans for AI/ML, remanufacturing of devices and medical device shortages are among the guidances the FDA Center for Devices and Radiological Health (CDRH) is prioritizing in 2024. The agency is seeking stakeholder feedback on the list of guidance documents it intends to publish in the coming year.
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions provides recommendations on what information to include in premarket submissions and emphasizes that cybersecurity is a component of quality system regulation.
The updated guidance clarifies how the program applies to medical devices that may address health inequities, as well as those that may increase access to care or provide a non-addictive treatment option to treat pain or addiction. It also clarifies the FDA’s current interpretation of the Breakthrough Device designation criteria.
