Weekly Policy Update: The FDA’s Initiatives For Medical Devices and the Upcoming Gubernatorial Candidate Forum
By: Colorado BioScience Association Date: 08/24/2018
FDA releases three important initiatives for medical device development, innovation and safety
The FDA announced it is taking steps to advance innovation and surveillance for medical devices through the implementation of three initiatives related to the recent user fee re-authorization.
In its first initiative, the FDA finalized the Voluntary Malfunction Summary Reporting Program, which allows medical device manufacturers to report device malfunctions in summary form on a quarterly basis. This will allow the FDA to efficiently detect potential safety concerns and provide additional resources and attention on addressing the highest risks.
The second initiative is a request for public commentary on a proposed list of accessories which general controls will provide assurance of safety and effectiveness. This effort is to fulfill a requirement of the FDA Reauthorization Act of 2017. Ultimately if the FDA classifies these accessories as low risk, it reduces the regulatory burden for those devices and helps support the agency’s risk-based approach. Resources can then be better focused on the products that pose the most risk to patients.
And finally, the FDA issued a draft guidance, Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices. According to the FDA it is intended to “provide clarity for those seeking these certificates, and the FDA will consider comments submitted about the draft guidance before determining a final approach.”
CBSA continues to applaud the FDA for efforts to streamline and create more efficient processes. To learn more about these initiatives click here.
Join CBSA, the Denver Metro Chamber of Commerce and business partners for the 2018 Gubernatorial Candidate Forum on Friday, October 5th!
This business-focused forum, moderated by the Denver Business Journal, will engage Colorado’s major party gubernatorial candidates — Democrat Congressman Jared Polis and Republican Treasurer Walker Stapleton. Join to hear their plans for ensuring a strong Colorado business climate.
For more information the event, the other business partners and to register click here.