mdi ConsultantsFDA Update – July 13, 2020
COVID-19 Update – FDA prepares for resumption of domestic inspections with new risk assessment system
As a follow up to the update of July 10 on this item we have broken out some of the more critical areas on the FDA On-Sight Inspectional restart.
The FDA is working towards resuming on-site inspections the week of July 20.
The FDA has adjusted their processes and guidance as necessary in order to maintain the appropriate level of review to ensure the safety of consumer products, including hand sanitizer, diagnostic tests, as well as more.
To assist investigators, the FDA has developed a rating system to help determine when and where it is safest to conduct prioritized domestic inspections. Known as, the COVID-19 Advisory Rating system (COVID-19 Advisory Level) uses real-time data to qualitatively assess the number of COVID-19 cases in a local area based on nation and state data. To assist state partners who carry out inspections of FDA-regulated entities on the agency’s behalf, the FDA is making the Advisory Level data available to their state partners.
The Advisory Level is based upon the outcome of three metrics:
- Phase of the State (as defined by the White House guidelines)
- Statistics measured at the country level to gauge the current trend
- Intensity of infection
Each of these metrics is taken into consideration in order for the FDA to identify regulatory activities that can occur within the given area. The three main categories of regulatory activity at the country level are:
- Mission critical inspections only
- All in inspections with caveats to help protect staff who have self-identified as being in vulnerable population
- Resumption of all regulatory activities
This restart will depend on the data about the virus’ trajectory in a given state and locality as well as the rules and guidelines that are put in place by state and local governments. Downward trends in new cases of COVID-19 and hospitalizations in a given area are needed in order to move to the next phase.
Prioritized domestic inspections will be pre-announced to FDA-regulated business in order to ensure the safety of the investigator and the company’s employees.
Please visit the FDA’s website to read the full news release.
If you have any further questions about this update or what this means for your company, please email mdi Consultants at [email protected] RE: Inspections.