Through audits or inspections, FDA may find that a medical device manufacturer is in violation of the federal Food, Drug, and Cosmetic Act (FDCA). Violations may include inadequate maintenance of complaint files, inappropriate claims about what the product does, flawed design controls, and other problems. FDA issues Warning Letters to companies when there is indication that a serious violation has occurred.
FDA Warning Letters include a detailed explanation of the specific violation and require an immediate response from the manufacturer explaining the corrective action that will be taken. It is important to note that Warning Letters are issued only for violations of regulatory significance, meaning they may lead to enforcement actions if corrective actions are not taken.
In Fiscal Year 2018, the most common quality system violations noted in FDA Warning Letters were related to procedures under the medical device quality system regulation 21 CFR Part 820 for Design Controls (820.30), Complaint Files (820.198), and Corrective and Preventive Action (820.100).
For a medical device company, FDA Warning Letters can delay or prevent premarket approval of medical devices. In addition, Warning Letters are published on the FDA website to protect patients and encourage manufacturers to take prompt action. Further, there are several potential legal ramifications. The FDA Warning Letter:
Enforcement actions may be taken if the violations are not addressed in a timely and thorough manner.
Unlike an FDA Warning Letter, Form 483 does not represent an FDA determination of violations. Instead it is meant to be a guide for corrective actions to be taken by the manufacturer based on an FDA inspectional review.
FDA inspects manufacturers of Class II and III medical devices at least every two years. In addition, inspections may occur under a variety of circumstances:
A written response to Form 483 Inspectional Observations is required within 15 working days. Not all Form 483 Observations result in a Warning Letter, but a company’s response may be used to gauge its willingness to comply with FDA regulations or to determine the need for follow up action. If a company’s response to issues documented with Form 483 is considered to be inadequate, or the violations are of a particularly serious nature, then an FDA Warning letter may be issued.
FDA Warning letters represent violations that may lead to regulatory action if not addressed properly. Like Form 483 observations, Warning Letters require a response within 15 working days. The response should include:
A primary goal of the company should be to reassure FDA that the product or practice in question is safe and effective, so all responses should be crafted with this in mind. It should be straightforward and clearly demonstrate how the issues raised in the FDA Warning Letter will be corrected. Unsupported claims should be avoided in the response to an FDA Warning Letter.
The quality and thoroughness of the response will often determine whether or not escalation to further regulatory or legal action is necessary.
Understanding FDA Warning Letters and how to appropriately respond to them is critical for any medical device company. But taking proactive steps to prevent the violation from occurring is a more effective, safe, and cost-saving approach. By focusing on quality, and not solely compliance, medical device companies decrease the likelihood of receiving complaints and investigations that escalate to Form 483 observations and FDA Warning Letters.
Greenlight Guru's medical device QMS software is an excellent starting point for medical device manufacturers who want to be sure they produce the safest and highest quality medical devices. Regulatory standards and best practices are built into the purpose-built software, so your team can focus on innovating products and improving the lives of patients.