FDA has the authority to regulate categories of cosmetics, drugs, devices, biologics, and foods. However, during the process, the FDA gives providence to the public and companies to weigh in regarding the process, and the CDRH petition is one of the ways to do so. Through this petition, there is an open dialogue between the industry and the FDA on the regulations from a practical standpoint, considering the industry’s observed practices.
For stakeholders in the industry, the CDRH petition provides an opportunity to address various issues, such as product recalls, revision of regulations for making them more stringent or lenient, around manufacturing processes and substances, and new or revised warning labels.
The Process to File A CDRH Petition
Anyone can prepare and file a CDRH petition, and they do not have to be a US citizen. If you are a petitioner, you can seek the assistance of a Regulatory Expert to compile necessary documentation and information for the petition.
If you are a trade association, you may file a CDRH petition on behalf of your members. The members are also free to file a petition on their own if they want to.
Once the applicant submits the application for a petition along with all the required documents, FDA will proceed to review the content of the petition. The FDA commissioner must take final action on a CDRH petition within 180 days of its submission. However, the FDA holds the discretion to deny a petition at any time if it does not fulfill the requirements set forth by the FDA.
CDRH Petition Checklist
All CDRH petitions must adhere to a certain format, and include a:
- “Action Requested” section, where you must state the action you are requesting the FDA commissioner to take. For example, revoke issues or amend a regulation, etc.
- “Statement of Ground” where you must provide legal and factual information to support your petition, even if some of it is unfavorable to your petition.
- “Assessment of environmental impact”; if a petition includes any environmental concern, it must include an assessment of environmental impact.
- “Economic Impact information” is only required if the FDA commissioner requests it after reviewing the petition.
- The petitioner must sign the undertaking to certify that the submitted petition includes all relevant documents and information to the best of his knowledge.
Submission: FDA does not accept email petitions. Petitions can either be mailed to the Division of Dockets Management, Food and Drug Administration or sent electronically. If you are a person, an organization, or association thinking about filing a CDRH petition, get an expert to help you. Elexes is a leading expert in regulatory affairs. Feel free to get in touch with Elexes to address the quality and regulatory requirements in your niche.