While we were all busy enjoying the holidays with friends and family, the FDA’s Center for Devices and Radiological Health was hard at work on an alert that summarized four significant developments with the potential to affect companies across the medical device industry. The alert was wide-ranging and included a proposed change to the 510(k) process, a proposed rule regarding the de novo classification process, some final guidance for breakthrough medical devices, and finally a report on the quality of inspections/enforcement. Let’s take a quick run through what’s changed.
The Proposed Revision to the 510(k) Pathway
In November 2018, FDA Commissioner Scott Gottlieb, M.D., announced a proposed revision to standard 510(k) pathway. Under the existing 510(k) regulatory approval process, a medical device can be found compliant if substantial equivalence is established with an existing, compliant, device that’s already being sold in the United States.
The FDA’s proposed revision requires companies seeking approval of an equivalent device to select a predicate that is current (within the last ten years) in an effort to keep pace with technological advances. According to Gottlieb, FDA data shows that approximately 20 percent of 510(k)s are cleared based on a predicate over 10 years old. The proposed revision would bring US approval standards closer in line with those recently adopted by the EU.
Proposed Rule on De Novo Classification Process
The proposed rule on the de novo classification was recently added to the Federal Register for formal comment. The changes would establish a pathway for the de novo classification to become part of the Medical Device Classification Procedures.
Under current rules, companies hoping to bring novel devices to market cannot use the 510(k) pathway because, as a new device, no equivalent devices exist. The de novo classification process is an alternative route that generally requires the firm to undergo costly, time-consuming, clinical trials. The proposed rule would allow for the classification of new types of medical devices as well as establish the processes and requirements for accepting, granting, declining, and withdrawing requests under the de novo classification process.
You can submit a comment regarding the proposed rule here. Comments must be submitted by March 7th, 2019.
Final Guidance Issued for Breakthrough Medical Devices
The 21st Century Cures Act passed into law on December 13th, 2016 was passed to help stimulate medical product development and bring much needed medical innovation to patients more efficiently. The act seeks to preserve the standards for regulatory clearance while expediting the development, evaluation, and review of medical device submissions.
The final guidance lays out the framework for the program’s tenets, including timely communication, efficient and flexible clinical study design, review team support, senior FDA management engagement, and priority review. The 30-page document also discusses the importance of balancing pre- and post-market data collection.
Some of the criteria for enrolling a new device in the program are:
- Whether or not the device could provide more effective treatment or diagnosis relative to the current standard of care.
- Whether the disease or condition being treated is “life-threatening or irreversibly debilitating.”
- Whether or not there are already existing alternatives to the new device.
- Whether the device offers significant, demonstrable, advantages over approved or cleared alternatives.
- Whether or not the device’s availability is in the best interest of potential patients.
- Whether or not the device represents a “breakthrough” technology.
The FDA states that approval or denial for breakthrough devices will occur within 60 days of its receipt.
Report on Enforcement and Quality
Again, in November 2018, the FDA released its report on enforcement and quality that included data on inspections of both US and foreign medical devices. Despite there being more than 21,000 registered device manufacturers spread between 106 countries, the FDA has increased its number of device inspections 46 percent since 2007. Similarly, the FDA increased its scrutiny of foreign companies, increasing the number of foreign device inspections a whopping 243 percent in the same 11-year period. Additionally, the FDA reported that it had also received and classified 600 MDSAP audits from 2013 to 2017.
The report goes on to detail the FDA’s risk-based enforcement approach, focus on adverse event reporting, and the steps it has taken to promote overall device quality.
Read the full report here.
What do you think of the proposed changes?
Have an opinion about the FDA’s recent changes or revisions? Let us know on LinkedIn or you can offer your comments by emailing [email protected].
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