The FDA’s Office of Communication, Information Disclosure, Training and Education (OCITE) has revamped the 510(k) Premarket Notification database by introducing six additional sub-categories. This update aims to streamline the search process for users seeking information on cleared medical devices, ensuring faster and more accurate data retrieval.
New Sub-Categories Simplify Device Searches
These newly added sub-categories include Combination Products, Cleared/Approved In Vitro Products, Redacted FOIA 510(k)s, Third Party Reviewed, Clinical Trials, and Predetermined Change Control Plan Authorized. Users can now filter their searches more precisely, allowing for simultaneous multiple sub-category searches. This enhancement addresses the need for targeted information, particularly benefiting industry stakeholders and the public who rely on specific device data.
Predetermined Change Control Plans Gain Focus
The introduction of the “Predetermined Change Control Plan (PCCP) Authorized” sub-category marks a significant advancement. This category caters to devices submitted under the 510(k) pathway that include a PCCP, as outlined in the FDA’s draft guidance. As of May 22, 2025, only 42 PCCPs across various product codes and review panels have been authorized, highlighting the specialized nature of this category.
Inferences:
- Enhanced search capabilities likely increase database usability and user satisfaction.
- Specific categories like PCCP reflect the FDA’s focus on detailed regulatory compliance.
- Industry stakeholders may experience reduced time in locating pertinent device information.
By refining the search functionalities within the 510(k) database, OCITE has effectively addressed previous limitations in information accessibility. Users can now effortlessly access detailed summaries and clinical trials data, exemplified by the streamlined search results for product code KGN.
Expanding the sub-categories not only facilitates better regulatory and compliance information access but also supports informed decision-making among manufacturers and healthcare providers. This update demonstrates the FDA’s commitment to enhancing transparency and efficiency in the medical device approval process.
These improvements are particularly beneficial for companies navigating the complexities of medical device submissions. With more precise search tools, businesses can better track competitor devices and regulatory changes, ultimately fostering a more competitive and innovative healthcare market.
Staying informed about such regulatory updates is crucial for stakeholders in the medical device industry. Leveraging the enhanced 510(k) database can lead to more strategic product development and compliance strategies, ensuring that devices meet both regulatory standards and market needs effectively.
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