FDA ratifies more than 200 petitions annually and only a few are successfully filed in the system. Anyone can file a petition to the CDRH; individuals, companies or non-governmental organizations. If there is a regulation pertaining to certain medical devices that you want to request to issue, amend or revoke, you can consider filing a petition for such purposes. The agency spends substantial time, manpower and finance attending to these petitions and setting guidelines in deciding what to accept.
Hence, only those who meet the requirements are considered.
What kind of CDRH Petition Have Been Filed So Far and Why?
Individuals submit petitions, but a majority of these come from industry or consumer groups. Common among the CDRH petitions are:
This is usually submitted by an individual or group to challenge a decision, raise an issue or request a review from the FDA. A Citizen petition when approved can:
● Warn about the labeling of certain medical devices.
● Disapprove a medical device product application.
● Request a change of products from prescription to over-the-counter status.
2. Request For Administrative Reconsideration
As per section 515(d)(4) of the FD&C Act, an applicant whose PMA has been rejected may file a petition requesting that the rejection be reviewed.
FDA accepts the petition when the prerequisite conditions have been followed
● If the petition proves that a vital piece of information and/or data previously in the administrative records were not sufficiently considered during the review process
● Position of petitioner is not insignificant and is solicited in good faith
● Reconsideration is not overshadowed by public health or other public well-being
● The petition demonstrates sound public policy grounds for reconsideration
3. Request for Administrative Stay of Action
This submission is allowed when a petitioner seeks to delay the effective date of an administrative action, such as the approval of a similar medical device or drug. Consideration will be given:
● If a request is filed within 30 days of an action. The commissioner can give an extension only if it serves a good cause
● The petition should clearly state the purpose or why the stay was requested and the grounds for requesting it
Impact of Approved Petitions on Patients and End Users
Oftentimes a petition may take weeks to more than a year to be processed by the FDA. This could be because of the issue’s complexity or due to certain delays at the agency.
Usually, when FDA accepts or rejects a submitted petition, it contacts the petitioner directly. If unsatisfied with the response, the petitioner may decide to take the case to court.
The following are two approved petitions that have made a difference:
Docket No: FDA-2012-P-0747
Petitioner: Leroy Leslie Hamilton Phd
Petitioner Type: Individual
Product Issue: Petitioner conducted an impartial investigation to determine whether Form FDA 3429 General Device Classification questionnaire is in compliance with the definition of class III.
Receipt Date: 7/10/12
Decision Date: 3/4/13
FDA investigated Form FDA 3429 and has determined that changes should be effected and closely aligned the form with section 513(a)(l)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Docket No: FDA-2009-P-0282
Petitioner: Pepper Hamilton, LLP
Petitioner Type: Individual
Product Issue: Petitioner requested an investigation on remote medication management systems for a determination of seizure, injunction and/or other appropriate relief since such devices being unapproved or misbranded.
Category: Medical Device
Receipt Date: 6/25/2009
Decision Date: 12/30/2009
FDA reviewed and investigated the petition. FDA had determined that the manufacturers or distributors violate the Federal Food, Drug and Cosmetic Act and decided to take appropriate action.
How Elexes Can Help?
If you need any assistance in submitting a petition for your medical devices and diagnostic tool, please feel free to email us at email@example.com.
Elexes is dedicated towards bringing functional and safe healthcare technologies to the market and helping ensure that the existing devices are in compliance. We will go the extra mile with you to get the right products to the market and keep them there.