Upon application of a State or a political subdivision thereof, the Secretary may, by regulation promulgated after notice and opportunity for an oral hearing, exempt from subsection (a), under such conditions as may be prescribed in such regulation, a requirement of such State or political subdivision applicable to a device intended for human use if— (1) the requirement is more stringent than a requirement under this chapter which would be applicable to the device if an exemption were not in effect under this subsection; or (2) the requirement— (A) is required by compelling local conditions, and (B) compliance with the requirement would not cause the device to be in violation of any applicable requirement under this chapter.2221 U.S.C. § 360k(a).23Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 345, 121 S. Ct. 1012, 1015, 148 L. Ed. 2d 854 (2001) (quoting and citing 21 U.S.C. § 360e(b)(1)(A)-(B)).24See generally id.25Id. at 346.26Id. (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 67 S. Ct. 1146, 91 L. Ed. 1447 (1947)).27Id. at 348.

BackgroundIn 2007, Congress enacted certain provisions of FDAAA to make clinical trial information more accessible to patients, health care providers, researchers, and the general public. To this end, FDAAA requires sponsors of certain clinical trials to register trials and to report two classes of results—“Basic Results” and “Expanded Results”—to ClinicalTrials.gov, a public database administered by the NIH. FDAAA requires “Responsible Parties”—sponsors or sponsor-designated principal investigators—to submit to NIH certain information about clinical trial results (referred to in the statute as “Basic Results”1) for “each applicable clinical trials [or “ACT”] for a drug that is approved under [21 U.S.C. § 355] or licensed under [42 U.S.C. § 262] or a device that is cleared under [21 U.S.C. § 360(k)] or approved under [21 U.S.C. § 360e or § 360j(m)].”2 The statutory text did not specify the date on which a product’s marketing status should be assessed for purposes of triggering the Basic Results reporting requirements.

Section 513 of the FDC Act (21 U.S.C. § 360c), added by the Medical Device Amendments of 1976 (“MDA”), requires FDA to classify all devices into one of three risk-based categories: Class I, Class II, or Class III. Devices assigned to Class III, representing the highest risk, must obtain premarket approval from the agency before they can be marketed. 21 U.S.C. § 360e(a). However, under section 515(b)(1) of the Act (21 U.S.C. § 360e(b)(1)), devices initially assigned to Class III, which were marketed prior to the May 28, 1976 enactment of the MDA – so-called “preamendments” devices, do not require submission of a premarket approval application (“PMA”) until after FDA issues a final rule requiring a PMA for that device, or, FDA publishes a final classification placing the device in Class III.

rmit scientific evaluation,” and with weaknesses in study design are not scientifically sound. Will FDA object to SIUU communications based on such studies that are not scientifically sound?FDA’s recommendation for firm-generated presentations of scientific information is limited to presentations that accompany reprints. Will FDA object to firm-generated presentations of scientific information that are not accompanied by a reprint, or that present scientifically sound and clinically relevant information not contained in the reprint?FootnotesAvailable at: www.fda.gov/regulatory-information/search-fda-guidance-documents/communications-firms-health-care-providers-regarding-scientific-information-unapproved-usesAvailable at: www.fda.gov/regulatory-information/search-fda-guidance-documents/distributing-scientific-and-medical-publications-risk-information-approved-prescription-drugs-and-devicesSee, e.g., Sections 505(a), 515(a), 501(f)(1), and 301(a) and (d) of the FDCA (21 U.S.C.A. 355(a), 360e(a), 351(f)(1) and 331(a) and (d)).See, e.g., FDA’s 2021 Intended Use Final Rule, 86 FR 41383 at 41386-41388.See the FDA Guidance, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers.”See, e.g., Washington Legal Foundation v. Henney, 202 F. 3d 331 (D.C. Cir. 2000); Unites States v. Caronia, 703 F.3d 149 (2d Cir. 2012).

ocess.” What is needed is a judge willing to study the statute and regulations, as well as the actual facts of the case presented, and, perhaps after asking the FDA for its views, to label these aspects of Lohr as the derelicts they are and bury them at sea. So far, no court has been willing even to ask the FDA for its views.[1] This article is based on Luther T. Munford, Courts v. FDA: A Lesson from Pelvic Mesh Litigation on Relative Competence to Decide a Legal Question, 76 Food & Drug L.J. 6 (2021) [hereinafter “Courts v. FDA”]. The authors and their firm, Butler Snow LLP, represent Ethicon in the pelvic mesh litigation discussed in this article. The views expressed in this article are those of the authors and are not made on behalf of Ethicon or any party.Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).Lambert v. California, 355 U.S. 225, 232 (1957) (Frankfurter, J. dissenting). 21 U.S.C. §360c(a)(1)(C)(ii)(II). 21 U.S.C. §360c(f)(1)(A)(ii)(II). 21 U.S.C. §360(k); 21 C.F.R. §807.100. 21 U.S.C. §360e; 21 C.F.R. §807.97.See Jeffrey K. Shapiro, Substantial Equivalence Premarket Review: The Right Approach for Most Medical Devices, 69 Food & Drug L.J. 365, 367–68 (2014) (suggesting the triage analogy). 21 U.S.C. §360c(f)(1)(A)(i). 21 U.S.C. §360(k).Medtronic, Inc. v. Lohr, 518 U.S. 470, 495–97 (1996).Id. at 490, 493, 478-479. 21 U.S.C. §§360c(a)(3)(B), 360c(f)(1)(A)(ii)(II).; 21 C.F.R. §807.81(a)(3). This is especially true since Congress in 1990 promulgated a statutory definition of substantial equivalence and prohibited marketing without FDA clearance. See FDA, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (July 27, 2014), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-substantial-equivalence-premarket-notifications-510k (“The 510(k) Program”).Riegel v. Medtronic, Inc., 552 U.S. 312, 322 (2008) (approval of Class III device triggers express preemption).Talley v. Danek Medical, Inc., 179 F.

As a result, they are governed by a distinct set of federal laws. Under 21 U.S.C. § 360e(1)(A)(ii)(III), anyone who receives a vaccine authorized under EUA must be informed "of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks." Courts have not interpreted this language, and experts have provided multiple interpretations.

In the new FAQs, NIH signals its acceptance of the Seife decision—which Ropes & Gray previously analyzed in an alert available —and confirms that certain trial results, previously thought to be exempted from FDAAA’s reporting requirements, will need to be reported after all.Seife v. HHSIn Seife, the U.S. District Court for the Southern District of New York ruled that the Department of Health and Human Services (“HHS”) had, through rulemaking, impermissibly narrowed the scope of clinical trials for which results must be reported, holding that HHS’s interpretation of FDAAA ran counter to the unambiguous language of the statute. In relevant part, FDAAA requires that “Responsible Parties”—sponsors or sponsor-designated principal investigators—report “Basic Results” for “each applicable clinical trial [or “ACT”] for a drug that is approved under [21 U.S.C. § 355] or licensed under [42 U.S.C. § 262] or a device that is cleared under [21 U.S.C. § 360(k)] or approved under [21 U.S.C. § 360e or § 360j(m)].”2 In the Federal Register preamble to the 2016 final rulemaking—but not in the final regulatory text—NIH provided its interpretation that “the marketing status of a product will be determined based on its marketing status on the primary completion date [of the ACT].”

[xviii] Riegel, 552 U.S. at 323. [xix] Id.See 21 U.S.C. 360e(d). [xx] Id.

Last year, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA) to revise and extend the user fee programs for drugs, medical devices and biosimilar biological products. Section 902 of FDARA requires FDA to publicly report, annually, information related to inspections of facilities necessary for approval of these medical products.Not later than March 1 of each year, the Secretary of Health and Human Services shall post on the internet website of the Food and Drug Administration information related to inspections of facilities necessary for approval of a drug under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), approval of a device under section 515 of such Act (21 U.S.C. 360e), or clearance of a device under section 510(k) of such Act (21 U.S.C. 360(k)) that were conducted during the previous calendar year. Such information shall include the following:(1) The median time following a request from staff of the Food and Drug Administration reviewing an application or report to the beginning of the inspection, and the median time from the beginning of an inspection to the issuance of a report pursuant to section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(b)).

Moreover, a recall is not a withdrawal of FDA approval. Compare: 21 U.S.C. § 360h(e); 21 C.F.R. §§ 810.10-18 (governing recalls), with 21 U.S.C. § 360e(e); 21 C.F.R. § 814.46 (governing withdrawal of approval). Or is the Guvenoz opinion saying that all it takes to nullify preemption is for the plaintiff to allege that the product should be withdrawn, whether or not the FDA ever gets around to ordering it?