21 C.F.R. §807.20 - Who must register and submit a device list?
| Cite as | 21 C.F.R. §807.20 |
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8 cases
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Connell v. Lima Corporate
...The district court also held that Lima was not a manufacturer of the Hip Stem under the BAAA given the FDA's determination pursuant to 21 C.F.R. § 807.20 that Lima "was exempt from FDA's registration and listing requirements as an entity that manufactured ‘devices for another party who both......
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In re Cryomedical Sciences, Inc. Securities Litigation
...propagation, compounding, or processing" of a device to register with the Food and Drug Administration ("FDA"). 21 U.S.C. § 360(b); 21 C.F.R. § 807.20(a).2 Such persons are required to file a list of devices which are being "manufactured, prepared, propagated, compounded, or processed ... f......
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Rebotix Repair LLC v. Intuitive Surgical, Inc., 8:20-cv-2274-VMC-TGW
...its remanufactured device into commercial distribution in the United States. 21 C.F.R. § 807.81(a)(2); 21 C.F.R. § 820.3(o); 21 C.F.R. § 807.20(a). [3] With the Court's permission, the parties first temporarily filed under seal their summary judgment motions, Daubert motions, the responses ......
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Cooney v. Howmedica Osteonics Corp. (In re Stryker Lfit V40 Femoral Head Prods. Liab. Litig.), MDL No. 17-md-2768-IT
...(i) A change or modification in the device that could significantly affect the safety or effectiveness of the device . . . .Page 6 21 C.F.R. § 807.20(a), in turn, provides that a person required to register his establishment is:An owner or operator of an establishment . . . who is engaged i......
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4 firm's commentaries
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Product Liability Update: October 2017
...plaintiffs’ motion, the manufacturers first argued plaintiffs’ claims against the distributor were preempted by 21 C.F.R. §§ 807.81 and 807.20(a)-(c), United States Food and Drug Administration (“FDA”) regulations which the manufacturers asserted prohibited a medical device distributor from......
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Shortages of PPE Drive FDA Guidance and Emergency Use Authorizations
...on the product, entities including manufacturers, initial importers, and repackers are typically required to register with FDA under 21 CFR § 807.20(a). Verify that products listed by the manufacturers correspond with the products for purchase and check the authenticity of any representatio......
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Product Liability Update: October 2017
...plaintiffs' motion, the manufacturers first argued plaintiffs' claims against the distributor were preempted by 21 C.F.R. §§ 807.81 and 807.20(a)-(c), United States Food and Drug Administration ("FDA") regulations which the manufacturers asserted prohibited a medical device distributor from......
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FDA Issues Draft Guidance On Transfer Of A 510(k) Clearance
...information annually, and new establishments are required to register and list within 30 days of entering into an operation described in 21 CFR 807.20(a). These provisions assure that FDA's database is reasonably Interestingly, the draft guidance states that if two or more firms claim to be......