October 25 2022
Who can submit a PMA?
The PMA applicant is usually the person who owns the rights, or otherwise has authorized access, to the data and other information to be submitted in support of FDA approval of the PMA. This person may be an individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit, or other legal entity. Often times the applicant is the inventor/developer and ultimately the manufacturer. If the applicant does not reside or have a place of business within the U.S., the PMA must be countersigned by an authorized representative who does. [§814.20]
Filing a PMA (21 CFR. 814.42)
During the administrative and limited scientific review, FDA determines whether a PMA is suitable for filing by reviewing the PMA submission for information required by the FD&C Act, the PMA regulations (21 CFR 814), and the PMA Acceptance and Filing Review Policy.
The filing of an application means that FDA has made a threshold determination that the application is sufficiently complete to begin an in-depth review. Within 45 days after a PMA is received by FDA, the agency will notify the applicant whether the application has been filed. The letter will include the PMA reference number and the date FDA filed the PMA. Expedited review status, if appropriate, may be communicated at this time. The date of filing is the date that a PMA accepted for filing was received by the agency. The 180-day period for review of a PMA starts on the date of filing.
Steps in the PMA Application Process
Statistical review for filing
Review of manufacturing information for compliance with the Quality System regulation (21 CFR 820).
PMA filing decision
Quality System Inspection(s) by the FDA field personnel. An FDA manufacturing inspection is may be conducted for all original PMAs and may be conducted for PMA supplements requesting approval of alternate or additional manufacturing and sterilization facilities.
Bioresearch Monitoring (BIMO) Audit (audit of clinical study data)
Substantive review coordination and completion
Early Collaboration & Day-100 Meetings
Applicants are encouraged to contact the FDA to obtain further guidance prior to the submission of a PMA application. This will be especially beneficial to new applicants who have not previously had contact with the FDA and for applicants proposing to study new technologies or new uses for existing technologies.
Early interaction with the FDA should help to increase the applicant's understanding of the FDA's requirements, regulations, and guidance documents, and will allow the FDA's personnel to familiarize themselves with the new technologies.
Increased interaction between the FDA and applicants should help to facilitate the regulatory process and minimize delays in the development of useful devices intended for human use.
A Pre-Submission provides the applicant with the opportunity to obtain the FDA's feedback prior to the submission of a marketing application.
During the Pre-Submission, the applicant will interact directly with the appropriate review Division. The applicant may request a formal written response, a face-to-face meeting, or a teleconference to address their concerns, questions, etc. Details about how to submit a Pre-Submission to the FDA for feedback.
In addition, the applicant may request a "determination" meeting with FDA. This meeting held early in device development will provide the applicant with the agency`s determination of the type of valid scientific evidence that will be necessary to determine if the device is effective for its intended use. FDA's determination is to be written, shared with the applicant within 30 days following the meeting.
The applicant may request a meeting (100-Day Meeting) to discuss the review status of the application. The meeting request should be submitted with the PMA or as an amendment to the PMA no later than 70 days from FDA receipt of the PMA accepted for filing or 70 days from submission of the amendment making the PMA filable ("filing date").
In the written request, the applicant should specify the type of meeting desired, e.g., face-to-face, teleconference, or videoconference, provide a list of the persons who will attend for the company, and identify several possible dates for the meeting. After a letter filing the application has been issued, the reviewing division will contact the applicant to set up the meeting if requested.
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