Nonbinding Feedback After Certain FDA Inspections of Device Establishments.

When a company is issued a FDA-483 List of Observations, at the close of an inspection of their operations, the consequences of not implementing a timely and most importantly, proper corrections can put the company in a precarious situation.

If FDA is not satisfied with how the company decided to handle the post-inspection compliance activities, an escalation of FDA enforcement will follow.  WOULDN’T it be “nice” to know if FDA is in agreement with your proposed corrective action plan before you actually implement it and submit a formal FDA-483 response?

FDA thought so too. To that end the, FDA has recently issued a draft guidance entitled, “Nonbinding Feedback After Certain FDA Inspections of Device Establishments” to comply with the FDA Reauthorization Act of 2017.  This draft guidance has presented a method for medical device manufacturers to request nonbinding feedback from the FDA. These non-binding feedback would be in response to certain observations and the FDA may document this on the 483 during an establishment inspection.  The FDA believes that timely, nonbinding feedback will assist manufacturers in determining whether their proposed corrective actions to address inspectional observations are adequate to avoid unnecessary investments on potential solutions.

The guidance details how an owner, operator, or agent in charge of a device establishment can submit a request for nonbinding feedback following the issuance of a Form 483.  A request for nonbinding feedback would have to be made in a timely manner (submitted no later than 15 business days after the issuance of a Form 483).

The FDA has recommended that if a company submits a FDA-483 response, the response as well as a request for nonbinding feedback be included in the same submission but as two separate documents.  Each request must contain a cover letter, followed by the inspectional observations that are being referenced, and a justification of why the requestor believes it is eligible for nonbinding feedback.

It is very important to note the FDA will only process those requests for feedback that pass the following three eligibility criteria for non-binding feedback:

• If the observations in a Form 483 require resolution because conditions result in the release of a violative product that may cause death or serious injury,
• If the observations in a Form 483 indicate that the quality system deficiencies can result in the production of nonconforming finished devices, and
• if the observations in a Form 483 relate to an emerging safety issue that can result in the release of devices that can cause serious injury or death.

OUCH!!! – In other words, if a company is interested in obtaining an FDA feedback on their corrective actions plan, this can only happen if the company self-admits in writing to FDA that the 483 observations are directly responsible for release of a violative product that can cause death or serious injury, or production of a non-conforming finished device or can lead to an emerging safety issue.

If the eligibility criteria are not met by a request, the FDA will notify the requestor within 45 calendar days.  If the FDA accepts the request, they are required to provide nonbinding feedback within 45 calendar days of the FDA’s receipt of the request.

FDA is estimating that 220 companies a year will request this type of FDA feedback.  Although this is just a draft guidance at the moment, we would strongly caution any of our clients and the medical industry for that matter, to carefully review all the implications of participating in this program before proceeding with it.  Although the FDA is attempting to work with the industry, possibly in an attempt to reduce the number of warning letters, it could be deadly for any company to admit that their devices are being manufactured out of compliance and could cause serious injury or even death.

The FDA is accepting comments on the new draft guidance document for 60 days starting on February 19, 2019 in the Federal Register under docket number FDA-2018-D-4711.  We encourage companies to submit their comments and express their concerns or raise questions that are important from the industry perspective. If this draft were to be implemented, we would recommend that you discuss your decision to use this guidance with your attorney’s before making any acknowledgement as to the regulatory condition of your company. It could put you in a very compromised position in the event any of products were involved in an Medical Device Reporting (MDR) situation.

 

? For any questions about how mdi can assist your company with a Form 483 response letter or comments or your regulatory requirement feel free to contact us at  info@mdiconsultants.com or use our contact form.