FDA will send the applicant an approval letter if the application substantially meets the requirements of the FD&C Act, and FDA believes that it may approve the application if specific additional information is submitted or if certain conditions are agreed to by the applicant. The approval letter describes the information that the FDA requires from the applicant or the conditions that the applicant must meet to obtain approval. For example, the FDA may require as a condition of approval: As of December 26, 2007, PMA applications must include Form FDA-3674. If your MAP contains data from a clinical trial, you must determine if your study is eligible for inclusion in the ClinicalTrials.gov Clinical Trials Registry database. Based on this layout, select the 9.B. or 9.C. check box and complete the appropriate sections of the form. An applicable product clinical trial is a prospective clinical health outcomes study that compares an intervention with a device to a human control (other than a small clinical trial to determine the feasibility of a device or a clinical trial to test prototype devices when the primary outcome measure is related to feasibility rather than health outcomes). See Part VIII – Clinical investigation databases. Currently, the FDA reviews legislation and develops clinical trial guidelines that meet the definition of “applicable” trials and must report to ClinicalTrials.gov. Until the FDA publishes these guidelines, the ART sponsor is responsible for determining whether its studies meet the applicable study definition and are therefore subject to reporting requirements. Human clinical trials conducted in the United States and U.S. territories must comply with Good Clinical Practice regulations.
These regulations include the Investigative Device Exemption (IDE) at 21 CFR 812, the protection of human subjects at 21 CFR 50, and institutional review committees at 21 CFR 56. An approved pre-market approval (MAP) application – such as an approved New Drug Application (NDA) – is actually a private licence granted to the applicant to market a particular medical device. A Class III product that does not meet the requirements of the AMP is considered adulterated under paragraph 501(f) of the Act and cannot be marketed. Pre-market approval requirements apply differently to previous variations, post-change devices and Class III transitional products. AMP post-approval approval requirements are requirements that apply to a product after it has been approved as part of a pre-market approval (AMP) application. The holder of an approved AMP must comply with all applicable post-market requirements required by product regulations. For more information, see Device Instructions on post-market requirements. Tip: The applicant`s summary section should objectively link the product`s medical claims to the tested assumptions and conclusions based on the results of all studies and investigations.
Biased presentation of study data and inclusion of advertising claims should be avoided. In preparing the abstract section, the applicant should be able to identify and address gaps in accountability, incomplete reporting, and gaps in study planning that would be revealed during a thorough scientific review. A properly developed applicant summary section can serve as a basis for summarizing FDA safety and efficacy data and facilitate the FDA and panel review process. A complete and explicit presentation of clinical trials and supporting data is required to meet the legal requirements of the FD&C Act. For a more detailed discussion of the design, documentation and submission of a clinical trial to demonstrate safety and efficacy, see “Statistical Guidance Document for Clinical Trials of Non-Diagnostic Medical Devices”. The 1976 amendments to medical devices in the federal Food, Drugs and Cosmetics Act (the Act) established three regulatory categories for medical devices. All three classes are based on the level of control needed to ensure that different types of devices are safe and effective. The most regulated devices are in Class III.
The amendments define a Class III device as one that supports or preserves human life or that is essential to prevent adverse effects on human health or that poses a potential and unreasonable risk of disease or injury. There is insufficient information on a Class III device so that performance standards (Class II) or general controls (Class I) cannot provide reasonable assurance that the device is safe and effective for its intended use. According to Article 515 of the Act, all Class III devices are subject to approval requirements before being placed on the market. Pre-market approval by the FDA is the necessary scientific review process to ensure the safety and effectiveness of Class III devices. Humanitarian use of equipment814.100 – Purpose and scope814.104 – Initial requests814.106 – HDE amendments and new applications HDE814.108 – Additional requests814.112 – Filing an HDE814.114 – Time limit for reviewing an HDE814.116 – Procedure for reviewing an HDE814.118 – Refusal of approval or withdrawal of approval of an HDE814.120 – Temporary suspension of approval of an HDE814.124 – Institutional Review Committee Requirements814.126 – Requirements and post-approval reports Before that changes affecting the safety or efficacy of the product can be made, the PMA holder must submit an ART supplement to the FDA for review and approval of that change. The exception is a type of amendment for which a “special MQP supplement – Pending Amendments” is permitted under Article 814.39(d) or another submission under Article 814.39(e). An ART supplement or other submission must comply with the applicable requirements under § 814.39 of the Final Premarket Approval Rule for Medical Devices. The holder of an approved AMP must meet the medical device reporting (MDR) requirements outlined in 21CFR 803. In addition, the AMP holder must: Modular AMP is the appropriate application method for products that have not yet completed the clinical trial. Candidates complete individual “modules”, with final confirmation given once all sections have been completed. For more information on the specific requirements of a modular PMA, see the FDA`s Modular Premarket Approval Application Review.
The existence of this PMA and the data and other information contained therein are confidential, and the protections afforded to such confidential information by 18 U.S.C. 1905, 21 U.S.C. 331(j), 5 U.S.C. 552 and other applicable laws are hereby asserted. [Tip: Confidentiality requests can only be invoked if the requester has met the applicable requirements. 814.20 – Application814.15 – Search outside the United States.814.39 – PMA supplements814.82 – Post-approval requirements814.84 – Reports FDA may deny approval of an AMP if the applicant does not comply with the requirements of the PMA regulations or if the FDA determines that one of the reasons for denying approval of an AMP under Section 515(d)(2)(A)-(E) of the FD&C The law applies. In addition, the FDA may deny approval of an ART for any of the following reasons: The applicant may be required to accept a post-approval study, restrictions on the use of prescriptions, or restrictions on the training of those authorized to use the device prior to approval. The applicant may also be informed of the necessary post-market surveillance and/or follow-up requirements. Applicants are advised to contact the FDA for more information before submitting an ART application. This will be particularly beneficial for new applicants who have not yet had contact with the FDA, and for applicants who propose to study new technologies or applications for existing technologies.
Early interaction with the FDA should help improve the applicant`s understanding of FDA requirements, regulations, and guidance, and allow FDA staff to become familiar with new technologies.