FDA Proposes More Formalized Form 483 Communications for Medical Devices
Regulatory Updates | Medical Devices
EMERGO BY UL SUMMARY OF KEY POINTS:
- US FDA proposes more transparent process for managing requests for feedback related to Form 483 observations;
- Requests for feedback to FDA from medical device manufacturers must meet eligibility criteria in order to receive responses;
- FDA will respond to requests for feedback and proposed corrective actions within 45 days.
The US Food and Drug Administration plans to formalize processes for managing feedback requests received from medical device companies cited for deficiencies following establishment inspections, helping firms to determine adequate responses and corrective actions.
New draft guidance from the agency would set up a standardized process through which companies that have received FDA Inspectional Observation Form (Form 483) inspectional observations may submit requests for nonbinding feedback, as well as for how the agency reviews and answers these requests.
Manufacturers may receive Form 483 notices following onsite inspections by FDA staff that identify quality system deficiencies or violations of the US Food, Drug and Cosmetics Act. Companies must respond to a Form 483 and describe planned courses of action to address cited observations within timeframes set by FDA.
Parameters of the Form 483 feedback request system
Establishing a process for timely nonbinding feedback is intended to help companies identify proper actions to rectify inspectional observations and avoid investing in corrective efforts that do not satisfy Form 483 issues. In general, FDA is required to provide nonbinding feedback within 45 days of receiving a request from a company.
The agency’s proposed system for managing Form 483 feedback requests includes recommendations for firms that have received Form 483 notices:
- Requests for nonbinding feedback should be submitted by the owner, operator or agent in charge of the company that receives a Form 483 notice;
- Feedback requests must be made in a timely manner, which means within 15 business days after issuance of a Form 483 notice.
- Feedback requests should be sent to the FDA contact designated to receive such submissions.
- Requests should include cover letters that provide company and establishment information and contact details, as well as justifications for how the requests meet eligibility criteria.
What qualifies as a request for nonbinding feedback
The new guidance lists three major eligibility criteria requests for nonbinding feedback must meet in order to qualify as such.
- First, a request must pertain to a Form 483 observation that requires corrective action because the identified issue has or may cause death or serious injury.
- Second, the Form 483 observation related to a request shows that a manufacturer’s quality system deficiencies have or will result in a defective or nonconforming device.
- Third, the Form 483 observation in question should related to an emerging safety issue that could result in commercialization of devices that may cause serious injury or death.
Companies submitting requests for nonbinding feedback should include justifications as to how their requests meet at least one of the criteria identified above; FDA is not obligated to respond to requests that fail to meet at least one of these criteria.
Finally, requests for feedback must include proposed actions by the manufacturer to address Form 483 observations. Descriptions and timelines of proposed actions as well as any pertinent supporting documentation should also be included.
How FDA will review and respond to Form 483 feedback requests
Once FDA receives a request for nonbinding feedback, the agency will first determine whether the request meets eligibility criteria; submitters of requests that do not meet eligibility requirements will be notified by FDA within 45 calendar days.
Qualified requests for feedback will receive responses from FDA within 45 calendar days of receipt of such requests. FDA responses will provide determinations as to whether submitters’ proposed corrective actions are adequate, partially adequate or inadequate.
In cases where the agency deems a proposed action partially adequate or inadequate, feedback will include reasons why the action in question does not appear adequate as well as recommendations to improve the proposed action.
However, the guidance notes that implementing proposed actions based on FDA nonbinding feedback may not prevent additional Form 483 observations, warning letters or other regulatory actions.
“It is the responsibility of the owners, operators, and agents of the device establishment to ensure compliance with applicable laws and regulations administered by FDA,” states the guidance.