Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1these products would be adulterated under section 501(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 351(f)(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 under section 520(g) of the Act, 21 U.S.C. § 360j(g). These products would also be misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the products into interstate commerce for commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).
Passage 2The labels and packages of the Banda-SiL products do not bear such a UDI.
Passage 3has not submitted to GUDID any information required by 21 CFR Part 830, subpart E, respecting these products.
Passage 4your firm’s medical device registration has been inactive since 2022 and your firm has not fulfilled annual device registration and listing requirements for fiscal year 2024.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 3.2(e)
- 21 CFR 801.20(a)
- 21 CFR 801.3
- 21 CFR 801.40(a)(1)
- 21 CFR 801.40(a)(2)
- 21 CFR 801
- 21 CFR 807.81(b)
- 21 CFR 830
- 21 CFR 830.300(a)
- 21 CFR 830.3