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Overview

The review of a premarket approval application (PMA) is a four-step review process consisting of:

• administrative and limited scientific review by FDA staff to determine completeness (acceptance and filing reviews);
• in-depth scientific, regulatory, and Quality System review by appropriate FDA personnel (substantive review);
• review and recommendation by the appropriate advisory committee (panel review); and
• final deliberations, documentation, and notification of the FDA decision.

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.

FDA will refuse to file the application for substantive review if a PMA application does not meet a minimum threshold of acceptability. If the information or data are presented unclearly or incompletely or are not capable of withstanding rigorous scientific review, FDA may consider the PMA incomplete and not file it. If FDA refuses to file a PMA, FDA will notify the applicant of the reasons for the refusal. This notice will identify the deficiencies in the application that prevent filing and will include the PMA reference number. FDA will advise the manufacturer of what information must be provided, or steps to be taken, to make the application fileable.

If FDA refuses to file the PMA, the applicant may:

• The applicant may resubmit the PMA with additional information necessary to comply with the requirements of section §515(c)(1)(A)-(G) of the FD&C Act and 21 CFR 814.20. A resubmitted PMA must include the PMA reference number of the original submission. If the resubmitted PMA is accepted for filing, the date of filing is the date FDA receives the resubmission;

• The applicant may request in writing within 10 working days of the date of receipt of the notice refusing to file the PMA, an informal conference with the Director of the Office of Device Evaluation to review FDA`s decision not to file the PMA. FDA will hold the informal conference within 10 working days after receiving the request and will make its decision on filing within 5 working days after the informal conference. If FDA then accepts the PMA for filing, the date of filing will be the date of the decision to accept the PMA for filing. If FDA does not reverse its decision, the applicant may request reconsideration of the decision from the Director of the Center for Devices and Radiological Health. The Director`s decision will constitute final administrative action for the purpose of judicial review.

Should the applicant decide to request a meeting concerning a refuse-to-file decision, the applicant must choose either: 1) an informal conference at which the decision not to file the application will be reviewed; or 2) a meeting with the ODE division to discuss the specific deficiencies and the measures necessary to correct these deficiencies. Please be advised that FDA will not typically grant requests for an informal conference and a meeting with the reviewing ODE division regarding this decision due to resource limitations. Applicants should either request an informal conference or schedule a meeting with the reviewing ODE division to discuss the preparation of an appropriate response.

FDA may refuse to file a PMA if FDA determines that any of the following applies:

• The application is incomplete because it does not contain all the information required under section 515(c)(1) (A)-(G) of the FD&C Act;
• The PMA does not contain each of the items required under Sec. 814.20 and justification for omission of any item is inadequate;
• The applicant has a pending Premarket Notification 510(k) with respect to the same device, and FDA has not determined whether the device falls within the scope of Sec. 814.1(c).
• The PMA contains a false statement of material fact.
• The PMA is not accompanied by a statement of either certification or disclosure as required by 21 CFR 54 Financial Disclosure by Clinical Investigators.

In-depth review (21 CFR 814.44)

FDA will begin substantive review of the PMA after it is accepted for filing (§814.42). During the review process, FDA will notify the PMA applicant via major/minor deficiency letters of any information needed by FDA to complete the review of the application. The applicant may request to meet with FDA within 100 days of the filing of the PMA to discuss the review status of the application. The procedure for 'Day-100 Meetings' can be found in the guidance document 'Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies - for Use by CDRH and Industry; Final'

If the applicant on their own initiative or at FDA`s request submits a PMA amendment (§814.37) which contains significant new data from a previously unreported study, significant updated data from a previously reported study, detailed new analyses of previously submitted data, or significant required information previously omitted, the review period may be extended up to 180 days.

Panel Review (21 CFR 814.44)

FDA may refer the PMA to an outside panel of experts (advisory committee). In general, all PMAs for the first-of-a-kind device are taken before the appropriate advisory panel for review and recommendation. However, as soon as FDA believes that (1) the pertinent issues in determining the safety and effectiveness for the type of medical device are understood and (2) FDA has developed the ability to address those issues, future PMAs for devices of that type are not be taken before an advisory panel unless a particular application presents an issue that can best be addressed through panel review.

The PMA, or relevant portions, may be forwarded to each member of the appropriate FDA advisory committee for review. During the review process, FDA may communicate with the applicant [§814.37(b)] or with the advisory committee to respond to questions that may be raised by committee members or to provide additional information to the panel. FDA will maintain a record of all communications with the applicant and with the advisory committee.

If the PMA is referred to an advisory committee, the committee must hold a public meeting to review the PMA in accordance with 21 CFR 14. The advisory committee must submit a final report to FDA that includes the committee's recommendation and the basis for such recommendation on the PMA. The advisory committee report and recommendation may be in the form of a meeting transcript signed by the chairperson of the committee.

The following document provides guidance for panel review.

FDA takes into consideration the transcript of the meeting, the panel`s recommendation(s), and other information in reaching a final decision on the PMA. FDA informs the applicant whether FDA agrees with the panel`s recommendation or disagrees and what additional information is needed from the applicant (approvable/not approvable decision). If the application is approvable, the applicant must agree to the 'Conditions of Approval.'

Standard Conditions of Approval

The 'Conditions of Approval' are the standard postapproval conditions imposed by FDA. These are applicable to all original PMAs and PMA supplements. As a condition of approval the sponsor agrees to abide by advertising and final printed labeling requirements and to submit adverse event reports, annual reports, and PMA supplements for certain changes. Additional specific conditions may be required for implanted devices. Applicants should carefully read the conditions of approval attached to the FDA approval letter. The 'Conditions of Approval' is available on the Internet.

Steps in the PMA Application Process

• ODE filing review
• OSB statistical review for filing
• OC review of manufacturing information for compliance with the Quality System regulation (21 CFR 820).
• PMA filing decision
• Day-100 Meeting
• Quality System Inspection(s) by the FDA field personnel. An FDA manufacturing inspection is 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 in areas such as:
  • Preparation of FDA Summary of Safety and Effectiveness Data (SSED)
  • Nonclinical Studies
    [Microbiological, Toxicological, Immunological, Biocompatibility, Shelf Life, Analytical (for IVDs), Animal, Engineering (Stress, Wear, Fatigue, etc.)]
  • Clinical Studies
  • Panel Meeting Decision and Mailing (if panel meeting is appropriate)
  • Panel Date (if appropriate)
  • Transcripts Received, Reviewed and Placed in Administrative Record
  • QS/GMP Clearance
  • Final Response from OC for GMP/BIMO
  • Final ODE Decision Memo
  • Approval Package
  • Approval Order, SSED, Final Draft Labeling

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.

The applicant may request feedback from the FDA through a Pre-Submission . 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 are provided in the FDA guidance Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.

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, and is binding upon the Agency, unless it would be contrary to public health. Additional information on determination meetings can be found in 'Early Collaboration Meetings under the FDA Modernization Act (FDAMA)'.

For certain medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions, the Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions guidance document introduces a new, voluntary program: the Expedited Access Pathway. The Expedited Access Pathway program intends to proactively work with sponsors to try to reduce the time and cost from development to marketing decision. Additional information about this and other aspects of the EAP program can be found at the Expedited Access Pathway Program webpage.

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'). This 30 day lead time is needed to allow FDA sufficient time to schedule the meeting. 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. For further information, please refer to the Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies - for Use by CDRH and Industry.

For general questions relating to the PMA laws, regulations, policies, and administrative issues, please contact the Division of Industry and Consumer Education (DICE) at 1-800-638-2041 or 301-796-7100, or via email at DICE@fda.hhs.gov. Or, you may contact the PMA Staff at (301) 796-5640.

FDA Action On a PMA

Within 180 days of the date of filing of the PMA (§814.40), FDA will complete its review of the PMA and of the advisory committee`s report and recommendation and issue one of the following:

• an approval order under §814.44(d),
• an approvable letter under §814.44(e),
• a not approvable letter under §814.44(f), or
• an order denying approval under §814.45.

Approval Order

After FDA reviews the committee`s final report, the FDA will issue an order to the applicant that the PMA is approved if none of the reasons in §814.45 (Denial of approval for a PMA) for denying approval of the application applies. FDA will approve an application on the basis of draft final labeling. Approval will be based on the condition that the applicant submits to FDA a copy of the final printed labeling before marketing.

FDA will notify the public of the approval. The announcement of the decision and the availability of a summary of the safety and effectiveness data (SSED) on which the decision is based will be published on the Internet. The summary will include information about any adverse effects of the device on health. The announcement also provides the applicant and other interested persons an opportunity for administrative review of the FDA approval under section 515(d)(3) of the FD&C Act. On a quarterly basis, FDA will publish a list of approvals announced during that quarter in the Federal Register. When a notice of approval is published, data and information in the PMA file will be available for public disclosure in accordance with §814.9.

Approvable Letter

FDA will send the applicant an approvable letter if the application substantially meets the requirements of the FD&C Act, and FDA believes that it can approve the application if specific additional information is submitted or specific conditions are agreed to by the applicant. The approvable letter will describe the information that FDA requires to be provided by the applicant or the conditions that the applicant is required to meet to obtain approval. FDA may require, for example, as a condition of approval:

• the submission of certain information identified in the approvable letter, such as final draft labeling;
• an FDA inspection that finds the manufacturing facilities, methods, and controls in compliance with the Quality System regulations (21 CFR 820) and, if applicable, verification of records pertinent to the PMA;
• restrictions imposed on the sale, distribution, or use of the device under section 515(d)(1)(B)(ii) or 520(e) of the FD&C Act; or
• postapproval requirements.

The applicant may have to agree to a postapproval study, restrictions on prescription use, or restrictions on the training of individuals who may use the device before approval. The applicant may also be notified of required postmarket surveillance and/or tracking requirements.

In response to an approvable letter, the applicant may:

• amend the PMA as requested;
• consider the approvable letter to be a denial of the PMA (21 CFR 814.45) and request administrative review [section 515(d)(3) of the FD&C Act] by filing a petition for reconsideration (21 CFR 10.33); or
• withdraw the PMA.

Not approvable letter

FDA will send the applicant a not approvable letter if FDA believes that the application may not be approved for one or more of the reasons given in §814.45(a) or if FDA is unable to reach an approvable decision due to a lack of significant information in the application. The not approvable letter will describe the deficiencies in the application, including each applicable ground for denial under section 515(d)(2)(A)-(E) of the FD&C Act. When practical, FDA will identify what is necessary to make the PMA approvable. In response to a not approvable letter, the applicant may:

• amend the PMA as requested [such an amendment will be considered a major amendment under §814.37(c)(1)];
• consider the not approvable letter to be a denial of approval of the PMA (§814.45) and request administrative review under section 515(d)(3) of the FD&C Act by filing a petition for reconsideration (21 CFR 10.33); or
• withdraw the PMA.

FDA will consider a PMA to have been withdrawn voluntarily if:

• the applicant fails to respond in writing to a written request for an amendment within 180 days after the date FDA issues such a request;
• the applicant fails to respond in writing to an approvable or not approvable letter within 180 days after the date FDA issues such a letter; or
• the applicant submits a written notice to FDA that the PMA has been withdrawn.

Service of orders (21 CFR 814.17)

Any FDA orders, such as approval or denial, will be emailed to the PMA applicant or its designated agent. A PMA applicant or its designated agent may arrange to pick up the FDA order at 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 by contacting the PMA Staff at 301-796-5640.

Denial of approval of a PMA (§814.45)

FDA may deny approval of a PMA if the applicant fails to follow the requirements of the PMA regulation or if FDA determines that any of the grounds for denying approval of a PMA specified in section 515(d)(2)(A)-(E) of the FD&C Act applies. In addition, FDA may deny approval of a PMA for any of the following reasons:

• The PMA contains a false statement of material fact.
• The device`s proposed labeling does not comply with the requirements in Part 801, Labeling, or Part 809, In Vitro Diagnostic Products for Human Use.
• The applicant does not permit an authorized FDA employee to inspect the facilities and controls in which the device will be manufactured or to have access to and to copy and verify all records pertinent to the application
• An essential nonclinical laboratory study described in the PMA was not conducted in compliance with the good laboratory practice (GLP) regulations in 21 CFR 58 and no reason for the noncompliance is provided, or, if it is, the differences between the practices used in conducting the study and the good laboratory practice regulations do not support the validity of the study.
• Any clinical investigation involving human subjects described in the PMA that is subject to the Institutional Review Board regulations in 21 CFR 56 or to the Informed Consent regulations in 21 CFR 50 and was not conducted in compliance with these regulations such that the rights or safety of human subjects were not adequately protected.

FDA will issue any order denying approval of a PMA in accordance with §814.17. The order will inform the applicant of the deficiencies in the PMA, including each applicable ground for denial under section 515(d)(2) of the FD&C Act and the regulations under Part 814, and, where practical, will identify measures required to place the PMA in approvable form. The order will include a notice of an opportunity to request review under section 515(d)(3) of the FD&C Act.

FDA will use the criteria specified in §860.7 (Determination of Safety and Effectiveness) in deciding whether to approve or deny approval of a PMA. FDA may use information other than that submitted by the applicant in making such determination.

FDA will publish a Federal Register notice of an order denying approval of the PMA. The notice will be placed on the Internet and will state that a detailed summary of information concerning the safety and effectiveness of the device, including information about any adverse effects on health, is available on the Internet and has been placed on public display. FDA will publish in the Federal Register after each quarter a list of the denials announced in that quarter. When a notice of denial of approval is made publicly available, data and information in the PMA file will be available for public disclosure in accordance with §814.9.

FDA will issue an order denying approval of a PMA after an approvable or not approvable letter has been sent and the applicant has:

• submitted the requested amendment but any ground for denying approval under section 515(d)(2) of the FD&C Act still applies; or
• notified FDA in writing that the requested amendment will not be submitted; or
• petitioned for review under section 515(d)(3) of the FD&C Act by filing a petition in the form of a petition for reconsideration (21 CFR10.33).

Withdrawal of approval of a PMA (21 CFR 814.46)

FDA may issue an order withdrawing approval of a PMA if FDA determines from any information available that:

• any of the grounds under section 515(e)(1)(A)-(G) of the FD&C Act applies;
• any postapproval requirement imposed by the PMA approval order or by regulation has not been met;
• an essential laboratory study described in the PMA was not conducted in compliance with the GLP regulations in 21 CFR 58 and no reason for the noncompliance is provided or, if it is, the differences between the practices used in conducting the study and the GLP regulation do not support the validity of the study; or
• any clinical investigation involving human subjects described in the PMA that is subject to the IRB regulations in 21 CFR 56 or to informed consent regulations in 21 CFR 50, was not conducted in compliance with these regulations, such that the rights or safety of human subjects were not adequately protected.

FDA may seek advice on scientific matters from any appropriate FDA advisory committee in deciding whether to withdraw approval of a PMA. FDA may also use information other than that submitted by the applicant in deciding whether to withdraw approval of a PMA.

Before issuing an order to withdraw approval of a PMA, FDA will issue the holder of the approved application a notice of opportunity for an informal hearing under 21 CFR 16. If the applicant does not request a hearing or, if after the 21 CFR 16 hearing is held, FDA decides to proceed with the withdrawal, FDA will issue an order withdrawing approval of the application. The order (§814.17) will state each ground for withdrawing approval and will include a notice of an opportunity for administrative review under section 515(e)(2) of the FD&C Act.

FDA will publish a Federal Register notice of an order withdrawing approval of a PMA. The notice will state that a detailed summary of information concerning the safety and effectiveness of the device, including information about any adverse effects on health, has been placed on public display and that copies are available upon request. When a notice of withdrawal of approval is published, data and information in the PMA file will be available for public disclosure under §814.9.

Temporary Suspension of Premarket Approval (§814.47)

If, after providing the sponsor with an opportunity for a regulatory informal hearing regarding the proposed withdrawal of PMA approval, and FDA determines there is a reasonable probability that continued distribution of a PMA-approved device would cause serious adverse health consequences or death, FDA shall by order temporarily suspend the PMA. In cases where there are sufficient grounds, FDA will proceed expeditiously to withdraw the PMA approval.

References

References for the PMA Review Process

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