Medical device manufacturer can now ask for FDA feedback after inspection

The FDA has notified in a draft that in coming times, they will offer nonbinding feedback after completion of their inspection at medical device manufacturer.

The FDA explained the complete procedure of nonbinding feedback in a 8 page document. The person to whom the Form FDA 483 belongs can apply for the feedback. Any other responsible person from the inspected company can also apply for the same. The time limit for requesting for nonbinding feedback is 15 working days after the completion of the inspection. A separate document with separate “cover letter” should be sent to the FDA for this while replying to the 483 document. Following things should be mentioned in the cover letter:

  1.  Header with a request for feedback
  2.  Name, address and contact details of the applicant
  3.  Name, address and FDA Establishment Identification (FEI) number along with the date of inspection
  4.  Justification regarding eligibility

The FDA reviews the request and respond within 45 days. In the feedback the regulatory body explains whether the mentioned actions to tackle inspectional observations are adequate, partially adequate, or inadequate. This feedback helps the inspected company to overcome the defects.