FDA Plans to Restart Inspections: Update

by | Jul 17, 2020 | FDA, Medical Devices, notified body, Requirements

Back in May, the FDA announced its intention to re-start domestic routine inspections (which you can read more about in our blog here). Last week, the FDA announced that it is planning to restart some on-site surveillance activities the week of July 20. This comes four months after putting all routine domestic inspections on hold due to COVID-19. In line with its update in May, the agency reiterated it will be following CDC guidelines to implement the plan safely, keeping the safety of FDA and industry staff as the top priority.

In order to determine when and where it is safest to resume inspections, the agency has developed the COVID-19 Advisory Rating system. This rating system assesses the number of COVID-19 cases in a local area and compares it against state and national data. The phase of the state as defined by White House and CDC guidelines, trending of cases, and intensity of infection for a particular geographic area are all taken into consideration in the rating system. The agency will use these metrics to determine which regulatory activities can resume on a county by county basis. The FDA has broken the regulatory activities down into 3 phases:1

  1. Mission-critical inspections only
  2. All inspections with caveats to help protect staff who have self-identified as being in a vulnerable population
  3. Resumption of all regulatory activities

The FDA stated that all investigators will be equipped with personal protective equipment and will be following all local, state, and CDC guidance. Additionally, the agency will pre-announce all routine domestic inspections to ensure firms will have the necessary staff on-site since many work teams have converted to telecommuting. Although the plan is to begin onsite inspections the week of July 20th, the agency recognizes that many factors could affect the ability to safely resume regulatory activities. In line with the CDC and most state and local guidelines, the FDA must see downward trends in new cases of COVID-19 and hospitalizations in a given area before they will begin considering onsite inspections.

Despite planning to resume normal regulatory activities, the agency cited its success in ensuring quality for regulated industries during the pandemic, despite not conducting onsite inspections. The FDA attributed this to its success with remote assessments and its adjusted processes and guidelines.2 If you need help preparing for upcoming FDA inspections, EMMA International can help get you ready. Call us at 248-987-4497 or email info@emmainternational.com to get connected with our team of FDA experts.

1FDA (July 2020) FDA prepares for resumption of domestic inspections with new risk assessment system retrieved on 07/15/2020 from: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-prepares-resumption-domestic-inspections-new-risk-assessment-system

2Rachal (July 2020) FDA plans to restart domestic inspections, contingent on local coronavirus trends retrieved on 07/15/2020 from: https://www.medtechdive.com/news/fda-plans-to-restart-domestic-inspections-contingent-on-local-coronavirus/581408/

Madison Wheeler

Madison Wheeler

Director of Technical Operations - Ms. Wheeler serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Ms. Wheeler also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Ms. Wheeler holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.

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