The list of actions omits the most controversial of the initial 55 proposals that came out last August, which could have required companies to conduct clinical studies on devices that were similar to existing products, according to a Bloomberg Businessweek report. The FDA will clarify when clinical studies are required to promote a more predictable decision-making process.
William Hawkins, CEO of Medtronic, told Bloomberg that the company was “encouraged” by the FDA’s release on the actions to implement in 2011.
Here is a report of the changes by month:
March:
• Post Council Charter to FDA website to: oversee development of business process and SOP; promote the development of improved quality metrics; periodically audit 510(k) review decisions; establish internal team of clinical trail experts to support and advice on clinical trail design.
• Pilot program to explore the use of “assurance case” framework for 510(k) submissions.
April:
• Hold public meeting on making device photographs available in public database without disclosing proprietary information.
• Hold public meeting on the development of an online labeling repository.
June:
• Draft guidance to clarify which changes do or do not warrant submission of a new 510(k) and which modifications are eligible for a Special 510(k).
• Post initial results of 510(k) audit to FDA website.
• Determine system requirements and select the new platform for a new adverse event database.
• Post SOP to FDA website to clarify and quickly inform stakeholders when CDRH has changed regulatory expectations on the bases of new scientific information.
• Complete program assessment on the root causes of existing challenges and trends in IDE decision making.
• Issue proposed regulation to permit rapid and accurate identification of devices and improve adverse event reporting and identification of device-specific problems.
July:
• Draft guidance to improve the equality and performance of clinical guidance.
• Formalize the Centers internal process for identifying staffing needs and enhance recruitment, retention and training.
• Post SOPs to FDA website clarifying the guidance and regulation development process.
August:
• Develop and implement training on core competencies, including: determination of “intended use”; determining whether 510(k) raises “different questions of safety and effectiveness”; review 510(k)s that use “multiple predicates”; develop and assign product codes; interpret “least burdensome” principles; appropriate use of consensus standards.
September:
• Draft guidance to streamline the de novo classification process.
• Draft guidance to provide greater clarity regarding when clinical data should be submitted in support of 510(k); submission of photographs or schematics for internal FDA use; appropriate the use of multiple predicates; the criteria for identifying “different questions of safety and effectiveness” and technological changes; resolving discrepancies between 510(k0 flowchart and the Food, Drug and Cosmetic Act; the characteristics that should be included in “intended use”; the development of 510(k) summaries to assure accuracy.
• Develop a network of external experts to leverage external scientific expertise and assess best practices and develop SOPs for staff engagement with external experts.
• Complete evaluation of methods used to integrate device information into a format so it can be used by staff to make regulatory decisions.
• Post SOP to FDA website of a process for regularly evaluating the list of device types eligible for third-party review and enhance the third-party reviewer training.
October:
• Draft guidance to clarify the appropriate use of census standards.
• Draft guidance to clarify the process for appealing CDRH decisions.
• Completed analysis and make results public on the apparent association between citing more than five predicates and a greater mean rate of adverse event reports.
November:
• Draft guidance to supplement available guidance on pre-IDE meetings and enhance the equality of pre-submission interactions between industry and Center staff.
December:
• Draft guidance to more consistently develop and assign unique product codes.
• Issue proposed regulation on better documentation of 510(k) transfers of ownership.
• Issue proposed regulation on clarifying the statutory listing requirements for the submission of labeling.
Read the full report on the plan for implementing FDA 510(k) changes in 2011 (pfd).
Read the Bloomberg Businessweek report on the FDA’s approval process.
Read other coverage on the FDA:
– 15 Spine Devices Receive FDA 510(k) Clearance in December
– 49 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in December
