42 CFR 405.201 - Scope of subpart and definitions
| Cite as | 42 CFR 405.201 |
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48 practice notes
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Yale-New Haven Hosp., Inc. v. Thompson, No. 3:99CV2546 (GLG).
...depending on whether initial questions as to the device's safety and effectiveness have been resolved. 42 C.F.R. §§ 405.201(b); 405.203. The intermediaries may approve coverage for any non-experimental/investigational IDE device in Category B if all other coverage requirements have been met......
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Harris v. Olszewski, No. 04-2479.
...a definition of "medical devices" that incorporates the definition of "devices" found in the FDCA. See 42 U.S.C. § 1395y(m)(2); 42 C.F.R. § 405.201(b). Having failed to enact a definition of "medical devices" that precludes the phrase from covering "incontinence products," having used a phr......
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U.S. v. Medtronic Inc., Civil Action No. H–08–3408.
...devices as to which the initial questions about the devices' safety and effectiveness had been resolved. See 42 C.F.R. §§ 405.201(b), 405.203, 405.211(b). In contrast to the total exclusion from coverage of such devices under the Manual provision, the new regulations classified such devices......
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Yale-New Haven Hosp. v. Leavitt, Docket No. 05-1224-CV-LEAD.
...that constituted refinements or replications of technologies that had already been demonstrated as being safe and effective.3 42 C.F.R. §§ 405.201(b), 405.211(b). The FDA classified all other devices in Category A (experimental/investigational), which continued to be excluded from Medicare ......
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16 cases
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Almy v. Sebelius, Civil Action No. RDB–08–1245.
...Instead, FDA approval is considered a necessary, but not sufficient, factor for purposes of determining Medicare coverage. See 42 C.F.R. § 405.201(a)(1) ( “CMS uses the FDA categorization of a device as a factor in making Medicare coverage determinations.”); see also 68 Fed. Reg. 55634, 556......
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United States ex rel. Modglin v. Djo Global Inc., Case No. CV 12–07152 MMM (JCGx).
...submit premarket approval (“PMA”) applications to the FDA and obtain premarketing clearance before offering the devices for sale.16 42 C.F.R. § 405.201(b). Class III devices that do not have PMA approval cannot be marketed and are considered “adulterated.” 21 U.S.C. § 351(f)(1)(B) (“A ... d......
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Yale-New Haven Hosp., Inc. v. Thompson, 3:99CV2546 (GLG).
...depending on whether initial questions as to the device's safety and effectiveness have been resolved. 42 C.F.R. §§ 405.201(b); 405.203. The intermediaries may approve coverage for any non-experimental/investigational IDE device in Category B if all other coverage requirements have been met......
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United States ex rel. Modglin v. DJO Global Inc., Case No. CV 12–07152 MMM (JCGx).
...must submit premarket approval ("PMA") applications to the FDA and obtain premarket clearance before offering the devices for sale.23 42 C.F.R. § 405.201(b). Class III devices that do not have PMA approval cannot be marketed and are considered "adulterated." 21 U.S.C. § 351(f)(1)(B) ("A .........
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9 firm's commentaries
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Updated FDA Guidance Helps Device Study Sponsors Better Anticipate Coverage For Investigational Devices
...10, 2013 Final Rule, published with FDA's concurrence, that centralized IDE review.6 Under the 2013 Final Rule, as codified at 42 C.F.R. 405.201(b): "Category A (Experimental) device refers to a device for which 'absolute risk' of the device type has not been established (that is, initial q......
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CMS Proposes to Expand the Scope of Medicare Coverage Determinations
...Integrity Manual, § 13.5.4, available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/pim83c13.pdf. [4] 42 C.F.R. §§ 405.201 – [5] 21 U.S.C. § 360e-3(b). [6] This includes premarket approval, Section 510(k) designated devices, and De Novo classification. [7] If, ......
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CMS Updates Policies and Procedures for National Coverage Determinations and Announces a New Expedited Process for Removing Certain Older NCDs
...can be safe and effective because, for example, other manufacturers have obtained FDA approval or clearance for that device type. 42 C.F.R. § 405.201(b). 5 In rare situations, CMS may issue a proposed decision concurrently with the opening of an NCD. This generally occurs when CMS determine......
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The Undefined, Definition of “Medical Necessity”
...determinations by commercial insurers as a factor in making Medicare coverage determinations. The Proposed Definition (To be Codified in 42 CFR 405.201) “We are proposing to codify the longstanding Program Integrity Manual definition of “reasonable and necessary” into our regulations at 42 ......
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