FDA / EU / Regulatory Updates
The EO includes requirements for sharing software bill of materials (SBOM)information when software is being delivered. The term “Software Bill of Materials” or “SBOM” means a formal record containing the details and supply chain relationships of various components used in building software.
Evaluation of premarket approval applications (PMA) by FDA is a multi-step process in which FDA evaluates whether reasonable assurance of device safety and effectiveness has been demonstrated.
To provide reasonable assurance, or the continued assurance, of safety and effectiveness of an approved device, FDA may require a post-approval study (PAS) as a condition of approval of the PMA. A PAS is usually a clinical or non-clinical study, as specified in the PMA approval order, and is typically intended to gather specific data to address questions about the post-market performance of or experience with an approved medical device.
FDA may consider it acceptable to collect certain data in the post-market setting, rather than premarket under certain circumstances when FDA has uncertainty regarding certain benefits or risks of the device, but the degree of uncertainty is acceptable in the context of the overall benefit-risk profile of the device at the time of premarket approval.
Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) provides the FDA with the authority to require manufacturers to conduct postmarket surveillance at the time of approval or clearance or at any time thereafter of certain class II or class III devices. Postmarket surveillance is the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device. The data collected under a surveillance order help to address important public health questions on the safety and effectiveness of a device.
This draft guidance document, when finalized, will assist manufacturers of devices subject to section 522 post-market surveillance orders (522 orders) by providing:
26 May 2021 is the application date for the EU MDR. After this date MDR is applicable for all medical devices sold (developed or imported) in the European Union. The In-Vitro Diagnostic Medical Device Regulation (IVDR) is set to follow in May of next year.
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