2024 FDA 年度注册费7653$， 无优惠和减免， 510（K）技术审评费 小规模5440$, 相比2023 分别递增17.87% 和9.52%！
2023 FDA 年度注册费6493$， 无优惠和减免， 510（K）技术审评费 小规模4967$，相比2022 分别递增14.47% 和55.90%！
2022 FDA 年度注册费5672$， 无优惠和减免， 510（K）技术审评费 小规模3186$
两个费用，年年递增，需要申请美国FDA医疗器械产品注册和备案和朋友，请联系深圳市思博达彭先生或登录公司网站www.bccgd.com。
赠送510K电子递交申报格式部分内容供参考，更多更详细的请联系深圳市思博达彭先生或登录公司网站www.bccgd.com。
Structure of the current eSTAR 510(k) Electronic Submission Template
1、Submission Type
Identification of key information that may be useful to FDA in the initial processing and review of the 510(k) submission, including content from current Form FDA 3514, Section A.
2、Cover Letter / Letters of Reference
Attach a cover letter and any documents that refer to other submissions.
3、Submitter Information
Information on submitter and correspondent, if applicable, consistent with content from current Form FDA 3514, Sections B and C.
4、Pre-Submission Correspondence & Previous Regulator Interaction
Information on prior submissions for the same device included in the current submission, such as submission numbers for a prior not substantially equivalent (NSE) determination, prior deleted or withdrawn 510(k), Q-Submission, Investigational Device Exemption (IDE) application, premarket approval (PMA) application, humanitarian device exemption (HDE) application, or De Novo classification request.
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9、Predicates and Substantial Equivalence34
Identification of a predicate device (e.g., 510(k) number, De Novo number, reclassified PMA number, classification regulation reference, if exempt and limitations to exemption are exceeded, or statement that the predicate is a preamendments device).
The submission should include a comparison of the predicate and subject device and a discussion why any differences between the subject and predicate do not impact safety and effectiveness [see section 513(i)(1)(A) of the FD&C Act and 21 CFR 807.87(f)]. A reference device should also be included in the discussion, if applicable. See “The 510(k) Program: evaluating Substantial Equivalence in Premarket Notifications [510(k)].”
10、Design/Special Controls, Risks to Health, and Mitigation Measures
Applicable to Special 510(k) submissions only.
Identification of the device changes and the risk analysis method(s) used to assess the impact of the change(s) on the device and the results of the analysis.
Risk control measures to mitigate identified risks (e.g., labeling, verification). See “The Special 510(k) Program
11、Labeling
Submission of proposed labeling in sufficient detail to satisfy the requirements of 21 CFR 807.87(e). Generally, if the device is an in vitro diagnostic device, the labeling must also satisfy the requirements of 21 CFR 809.10. Additionally, the term “labeling” generally includes the device label, instructions for use, and any patient labeling. See “Guidance on Medical Device Patient Labeling.”
12、Reprocessing
Information for assessing the reprocessing validation and labeling, if applicable. See “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
13、Sterility
Information on sterility and validation methods, if applicable. See “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile
14、Shelf Life
Summary of methods used to establish that device performance is maintained for the entirety of the proposed shelf-life41(e.g., mechanical properties, coating integrity, pH, osmolality), if applicable
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