{"id":82373,"date":"2026-07-02T00:05:32","date_gmt":"2026-07-02T00:05:32","guid":{"rendered":"https:\/\/english.saigonbiz.com\/vn\/memphis-surgeon-seeks-to-overturn-conviction-citing-fda-guidance-on-medical-devices-with-national-experts-aghast-at-overzealous-persecution-despite-fda-safe-harbor\/"},"modified":"2026-07-02T00:05:32","modified_gmt":"2026-07-02T00:05:32","slug":"memphis-surgeon-seeks-to-overturn-conviction-citing-fda-guidance-on-medical-devices-with-national-experts-aghast-at-overzealous-persecution-despite-fda-safe-harbor","status":"publish","type":"post","link":"https:\/\/english.saigonbiz.com\/vn\/memphis-surgeon-seeks-to-overturn-conviction-citing-fda-guidance-on-medical-devices-with-national-experts-aghast-at-overzealous-persecution-despite-fda-safe-harbor\/","title":{"rendered":"Memphis Surgeon Seeks to Overturn Conviction, Citing FDA Guidance on Medical Devices with\u00a0National Experts Aghast at Overzealous Persecution Despite FDA Safe Harbor"},"content":{"rendered":"
\n

Sworn Declarations from Former FDA Counsel and Renowned Device Regulation Expert Expose Clear Regulatory Carve-Outs for Outpatient Clinics; Emergency Motion Seeks to Strike Verdict Before July 7 Sentencing<\/em><\/p>\n

MEMPHIS, Tenn., July 01, 2026 (GLOBE NEWSWIRE) — Memphis surgeon Dr. Sanjeev Kumar has filed an emergency post-conviction motion asking a federal judge to set aside his conviction, arguing that the Department of Justice’s prosecution conflicts with the U.S. Food and Drug Administration’s published guidance on the reprocessing of single-use medical devices.<\/p>\n

The motion, filed June 30 in the U.S. District Court for the Western District of Tennessee, seeks relief before Dr. Kumar’s July 7 sentencing hearing. It argues that FDA guidance exempts outpatient physician offices from certain enforcement priorities applicable to hospitals and third-party reprocessors.<\/p>\n

The filing includes sworn declarations from Stephen D. Terman, former Associate Chief Counsel for Enforcement at the FDA, and Dr. Edward R. Teitel, a surgeon and FDA regulatory attorney. According to the motion, both experts conclude that outpatient physician practices fall within FDA guidance excluding “health care facilities that are not hospitals” from the enforcement framework at issue in the case.<\/p>\n

The defense also argues that several medical devices cited in the indictment are Class I hysteroscopy accessories exempt from certain FDA premarket and labeling requirements. The motion contends the government’s legal theory is inconsistent with FDA regulations and guidance governing those devices.<\/p>\n

Dr. Kumar asks the court to vacate the jury’s verdict or, alternatively, allow him to remain on bond while pursuing post-conviction relief and an appeal. Defense counsel has requested an expedited hearing before the scheduled sentencing proceedings.<\/p>\n

References<\/strong><\/p>\n

    \n
  1. United States v. Sanjeev Kumar<\/em>, No. 25-cr-20032, U.S. District Court for the Western District of Tennessee, Emergency Post-Conviction Motion filed June 30, 2026.<\/li>\n
  2. Declaration of Stephen D. Terman in support of Defendant’s Emergency Post-Conviction Motion, filed June 30, 2026.<\/li>\n
  3. Declaration of Edward R. Teitel, M.D., J.D., in support of Defendant’s Emergency Post-Conviction Motion, filed June 30, 2026.<\/li>\n
  4. U.S. Food and Drug Administration,\u00a0Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals<\/strong>, August 14, 2000.<\/li>\n
  5. 21 C.F.R. \u00a7 884.1690 (Gynecologic endoscopy accessories; Class I device classification and applicable exemptions).<\/li>\n
  6. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. \u00a7\u00a7 301 et seq.<\/li>\n<\/ol>\n
    CONTACT: Contact:\r\nPatrick Collins\r\nMMG Memphis\r\nEmail:\u00a0patrick@mmgmemphis.com\r\nCell: (901) 219-9944<\/pre>\n
    \"\"<\/div>\n","protected":false},"excerpt":{"rendered":"
    Sworn Declarations from Former FDA Counsel and Renowned Device Regulation Expert Expose Clear Regulatory Carve-Outs for Outpatient Clinics; Emergency Motion Seeks to Strike Verdict Before July 7 Sentencing MEMPHIS, Tenn., July 01, 2026 (GLOBE NEWSWIRE) — Memphis surgeon Dr. Sanjeev Kumar has filed an emergency post-conviction motion asking a federal judge to set aside his […]\n","protected":false},"author":1,"featured_media":85254,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[],"class_list":["post-82373","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-people"],"yoast_head":"\nMemphis Surgeon Seeks to Overturn Conviction, Citing FDA Guidance on Medical Devices with\u00a0National Experts Aghast at Overzealous Persecution Despite FDA Safe Harbor - Biz and Live in Saigon<\/title>\n<meta name=\"robots\" content=\"index, follow, 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