The New 510(k) Pathway: A Guide to Updated Requirements
The FDA is modernizing the 501(k) framework to reflect advances in technology, safety and the capabilities of a new generation of medical devices.
What does this mean for your 510(k) submissions? You will need to know:
- How to identify strong predicate devices
- Common adverse events encountered in different device classes
- Biocompatibility requirements
- The best questions to ask to get the most out of a pre-submission meeting
- Additional testing you may need to conduct
- Strategic considerations when working with the FDA
The New 510(k) Pathway: A Guide to Updated Requirements management report explains the new rules for selecting predicate devices, changes in device classification, opportunities for pre-submission meetings with the agency, additional postmarket testing requirements and expansion of the third-party review program. This report covers two FDA pilot programs — the Software Precertification Program and Quality in 501(k) Review — along with a special safety and performance pathway for well-understood devices, changes to the de novo clearance pathway and the agency’s electronic submission requirements.
Management report takeaways:
- How to search for similar devices to use as predicates
- What devices are exempt from the 510(k) process and which ones should use the de novo pathway
- Criteria for suitable predicates
- How to determine what testing is necessary and what kinds of tests to use
- How to use the FDA databases to find product codes and consensus standards
- Software validation requirements
- How processes differ for reprocessed single-use devices
Streamline your 510(k) submissions and shorten your time to clearance with The New 510(k) Pathway: A Guide to Updated Requirements management report. Order your copy today.
Who Will Benefit
- Regulatory affairs specialists
- Medical device consultants
- Biomedical engineers or R&D engineers working in product development
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