Is the 510(k) Pathway Robust Enough for the Era of AI?
Author:
Affiliation:
1. Haywards Heath
Publisher
Anderson Publishing, Ltd.
Reference8 articles.
1. FDA.gov. The 510(k) program: evaluating substantial equivalence in premarket notifications. 2023. https://www.fda.gov/media/82395/download. Accessed Feb. 6, 2023.
2. The FDA and the vaginal mesh controversy—further impetus to change the 510(K) pathway for medical device approval;Jacoby;JAMA Intern Med.,2016
3. The 510(K) ancestry of transvaginal mesh;Rosh;JAMA Surgery,2021
4. Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process;Heneghan;BMJ Open,2017
5. Artificial intelligence performance in detecting tumor metastasis from medical radiology imaging: a systematic review and meta-analysis;Zheng;Eclinical medicine,2021
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