| Action | Practice of dry needling |
| Stage | Proposed |
| Comment Period | Ended on 7/26/2019 |
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An acupuncture needle is a restricted medical device under section 520(e) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. § 360j(e)) [1].
The U.S. Food and Drug Administration (FDA) restricted the sale, distribution, and use of an acupuncture needle “to prescription use” [2]. In addition, FDA further restricted the sale, distribution, and use of an acupuncture needle “to qualified practitioners of acupuncture as determined by the States” [3]. (FDA determined that this restriction is required for the safe and effective use of an acupuncture needle [2].) Therefore, it is a violation of Federal law when an acupuncture needle is purchased, possessed, or used by unqualified practitioners of acupuncture, such as physical therapists [4].
1. See 21 U.S.C. § 360j(e); 21 CFR § 807.3(i); 21 CFR § 880.5580(b)(1); 21 CFR § 801.109; see also 61 Fed.Reg. 64616 (Dec. 6, 1996).
2. See 61 Fed.Reg. 64616 (Dec. 6, 1996); see also 21 U.S.C. § 360j(e); 21 CFR § 807.3(i); 21 CFR § 880.5580(b)(1); 21 CFR § 801.109.
3. See 61 Fed.Reg. 64616 (Dec. 6, 1996) (emphasis added); see also 21 U.S.C. § 360j(e); 21 CFR § 807.3(i); 21 CFR § 880.5580(b)(1); 21 CFR § 801.109.
4. See 21 U.S.C. §§ 331(a)–(c), (g), and (k); 21 U.S.C. §§ 352(q) and (r).