Jiangsu Shenli Medical Production Co., Ltd.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

FDA has determined, based on information provided by your firm and information available on the Agency's public databases, that the Jiangsu Shenli Medical Production Co. Ltd. piston syringes configurations listed in **Table 1** are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(0(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g).

Passage 2

The devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution these devices with (1) major changes or modifications to the intended use, and/or (2) a change or modification in the device that could significantly affect the safety or effectiveness of the device without submitting a premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(i)-(ii).

Passage 3

Based on FDA's evaluation of your firm's activities, there is evidence that your firm is engaged in the distribution of syringes for use within the United States with substantially different technological characteristics, namely sizes other than 5 mL, luer slip instead of luer lock tips, syringes intended for specific drugs, different colors (i.e., colorants), and control syringes, each of which constitute a significant change or modification in design that could significantly alter the safety or effectiveness of the device.

Passage 4

Your firm's failure to submit 510(k)s for these devices has prevented FDA from evaluating the risks posed by these substantially different technological characteristics or from determining that there is reasonable assurance of the safety and effectiveness of these modified devices such that they may be legally marketed syringes.