9Reprocessors and repackagers may sterilize, refurbish, or repackage previously used devices. There are special requirements for those who reprocess single-use medical devices. Section 502(v); 21 USC 352(v) (2006).
Page 44 Suggested Citation:"3 Components of US Medical-Device Regulation." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150. × SaveCancel
name and all places of business.10 Any additional place of business must be registered immediately.11 Registration is also required for establishments outside the United States where devices are made for importation into the United States.12 Registration is to be electronic.13
Listing of Products
Each registered person must file with the FDA a list identifying each device made or processed for commercial distribution in the United States.14 The label and labeling15 for each listed device and a representative sample of other labeling must be provided.16 The FDA may request a registrant to provide a statement as to why it believes that any product listed is not subject to a performance standard or a premarket approval (PMA) application requirement.17 If a device previously listed is no longer made, the registrant must provide a notice of discontinuance regarding the product.18 Listings are to be electronic.19
If the FDA determines that a device’s potential for harm or collateral measures necessary for its use are such that there cannot be reasonable assurance of its safety and effectiveness without the restriction, the agency is authorized to require that the device be restricted to sale, distribution, or use, only on the written or oral authorization of a healthcare practitioner or “upon such other conditions as [the FDA] may prescribe.”39 The statute goes on to suggest both the types of other conditions that the FDA might consider and limitations of these conditions if used:
No condition … may restrict the use of a device to persons with specific training or experience in its use or to persons for use in certain facilities unless [the FDA] determines that such a restriction is required for the safe and effective use of the device. No such condition may exclude a person
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34FFDCA § 519(a), 21 USC § 360i(a) (2006). See 21 CFR pt. 803 (2009) (implementing regulations).
Page 47 Suggested Citation:"3 Components of US Medical-Device Regulation." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150. × SaveCancel
from using a device solely because the person does not have the training or experience to make him eligible for certification by a certifying board recognized by the American Board of Medical Specialties or has not been certified by such a Board.40
That authority is exercised at the FDA’s discretion and may by imposed in any of three ways: by regulation issued through a notice-and-comment rule-making (usable for devices in any class),41 as part of a performance standard established by notice-and-comment rule-making (usable only for Class II devices),42 or as a condition for the approval of a PMA application (usable only for Class III devices).43
Although the language is quite similar to that used by the FDA to determine whether a device should be a prescription device,44 the designations as “restricted device” and “prescription device” are technically distinct. Numerous devices are recognized as “prescription devices” by their manufacturers and the FDA through labeling and fall under exemptions from the “adequate directions for use” requirements.45 Those devices, however, are not “restricted devices” unless separately designated by the FDA.
The FDA has generally used the restricted-device authority via the PMA application process and rarely by regulation (Hutt et al., 2007). Only a very few Class II devices are formally “restricted.”46
As early as 1983, however, the FDA was being criticized in Congress for failing to use its power to impose other conditions on use:
The legislative history [of the 1976 amendments] explains that Congress sought to supersede and add to the existing authority used by the FDA to limit sale or use of certain devices except by prescription. Authority beyond prescription was necessary because many … believed that major problems arose from misuse of devices by practitioners, and not just from manufacturing or design defects. Establishing conditions under which devices could be used, or limiting or describing the facilities where they could be used, or the training or qualification of those who use them in treatment, was envisioned as a way to address user-related problems. Controls such as these were not contemplated by the lone previously existing authority to limit devices to a practitioner’s prescription.47
47Subcomm. on Oversight and Investigations of the H. Comm. on Energy and Commerce, 98th Cong., Medical Device Regulation: The FDA’s Neglected Child (Comm. Print 98-F).
Page 48 Suggested Citation:"3 Components of US Medical-Device Regulation." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150. × SaveCancel
Once a device is designated as a restricted device, two additional important legal consequences—apart from limiting access to the device to or through physicians—result:
路上和办事的地方都人少了很多。办公机构都雇了很多人消毒，凡是门把手还有扶梯人摸到的地方都是湿的，估计一会走一遍。进门也要先消毒手才可以进去。
这里有做服装的公司停产改做口罩供应当地医院，因为厂里需要保持人之间的距离裁布料没有问题（都是机器裁一裁厚厚一落），现在呼吁社会家庭有缝纫机的来领料回家加工。回头让老婆大人也去领一包回来缝。
逛坛子也只找和家人有关的。太不关心自己了
昨天去机场接人，一路上都没几辆车。很爽，但同时真担心经济啊。如果这个样子持续一个月，美国经济就彻底衰退，那个不是每人发几千块能搞掂的。God bless America.
只要挺过去，没准人类能柳暗花明。
请医院直接和供货商联系，咱们出钱买口罩和防护服，让供货商直接把防护用品交给医院的进货部门。
搞不清现在一些医院是不知道国内有多余口罩，还是没有足够的资金去买。
Mandates
Registration of Manufacturers
A US-located manufacturer, processor, packager (or reprocessor and repackager9) of a medical device must register with the FDA the business’s
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1Federal Food, Drug, and Cosmetic Act [hereinafter FFDCA] § 501(a)(1); 21 USC § 351(a)(1) (2006).
2FFDCA § 501(a)(4), 21 USC § 351(a)(4)(B) (2006).
3FFDCA § 501(a)(3), 21 USC § 351(a)(3) (2006).
4FFDCA § 501(e), 21 USC § 351(a)(1) (2006).
5FFDCA § 502(a), 21 USC § 352(a) (2006).
6FFDCA § 502(c), 21 USC § 352(c) (2006).
7FFDCA § 201(n), 21 USC § 321(n) (2006).
8FFDCA § 502(j), 21 USC § 352(j) (2006).
9Reprocessors and repackagers may sterilize, refurbish, or repackage previously used devices. There are special requirements for those who reprocess single-use medical devices. Section 502(v); 21 USC 352(v) (2006).
Page 44 Suggested Citation:"3 Components of US Medical-Device Regulation." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150. × Save Cancelname and all places of business.10 Any additional place of business must be registered immediately.11 Registration is also required for establishments outside the United States where devices are made for importation into the United States.12 Registration is to be electronic.13
Listing of Products
Each registered person must file with the FDA a list identifying each device made or processed for commercial distribution in the United States.14 The label and labeling15 for each listed device and a representative sample of other labeling must be provided.16 The FDA may request a registrant to provide a statement as to why it believes that any product listed is not subject to a performance standard or a premarket approval (PMA) application requirement.17 If a device previously listed is no longer made, the registrant must provide a notice of discontinuance regarding the product.18 Listings are to be electronic.19
Controls Applicable Only to Higher-Risk Devices
Restricted Devices
If the FDA determines that a device’s potential for harm or collateral measures necessary for its use are such that there cannot be reasonable assurance of its safety and effectiveness without the restriction, the agency is authorized to require that the device be restricted to sale, distribution, or use, only on the written or oral authorization of a healthcare practitioner or “upon such other conditions as [the FDA] may prescribe.”39 The statute goes on to suggest both the types of other conditions that the FDA might consider and limitations of these conditions if used:
No condition … may restrict the use of a device to persons with specific training or experience in its use or to persons for use in certain facilities unless [the FDA] determines that such a restriction is required for the safe and effective use of the device. No such condition may exclude a person
___________________
34FFDCA § 519(a), 21 USC § 360i(a) (2006). See 21 CFR pt. 803 (2009) (implementing regulations).
35FFDCA § 519(a)(8), 21 USC § 360i(a)(8) (2006).
3621 CFR pt. 803, subpts. D–E (2009).
37FFDCA § 519(b), 21 USC § 360i(b) (2006).
3821 CFR pt. 803, subpt. C (2006).
39FFDCA § 520(e), 21 USC § 360j(e) (2006).
Page 47 Suggested Citation:"3 Components of US Medical-Device Regulation." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150. × Save Cancelfrom using a device solely because the person does not have the training or experience to make him eligible for certification by a certifying board recognized by the American Board of Medical Specialties or has not been certified by such a Board.40
That authority is exercised at the FDA’s discretion and may by imposed in any of three ways: by regulation issued through a notice-and-comment rule-making (usable for devices in any class),41 as part of a performance standard established by notice-and-comment rule-making (usable only for Class II devices),42 or as a condition for the approval of a PMA application (usable only for Class III devices).43
Although the language is quite similar to that used by the FDA to determine whether a device should be a prescription device,44 the designations as “restricted device” and “prescription device” are technically distinct. Numerous devices are recognized as “prescription devices” by their manufacturers and the FDA through labeling and fall under exemptions from the “adequate directions for use” requirements.45 Those devices, however, are not “restricted devices” unless separately designated by the FDA.
The FDA has generally used the restricted-device authority via the PMA application process and rarely by regulation (Hutt et al., 2007). Only a very few Class II devices are formally “restricted.”46
As early as 1983, however, the FDA was being criticized in Congress for failing to use its power to impose other conditions on use:
The legislative history [of the 1976 amendments] explains that Congress sought to supersede and add to the existing authority used by the FDA to limit sale or use of certain devices except by prescription. Authority beyond prescription was necessary because many … believed that major problems arose from misuse of devices by practitioners, and not just from manufacturing or design defects. Establishing conditions under which devices could be used, or limiting or describing the facilities where they could be used, or the training or qualification of those who use them in treatment, was envisioned as a way to address user-related problems. Controls such as these were not contemplated by the lone previously existing authority to limit devices to a practitioner’s prescription.47
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40Id.
41Id.
42FFDCA § 514(a)(1), (b), 21 USC § 360d(a)(1), (b) (2006).
43FFDCA § 515(d)(1)(B)(ii), 21 USC § 360e(d)(1)(B)(ii) (2006).
4421 CFR § 801.109(a) (2009).
45See above regarding “Labeling with Adequate Instructions for Use.”
4621 CFR § 801.420, 21 CFR § 809.30, 21 CFR § 864.4020(d).
47Subcomm. on Oversight and Investigations of the H. Comm. on Energy and Commerce, 98th Cong., Medical Device Regulation: The FDA’s Neglected Child (Comm. Print 98-F).
Page 48 Suggested Citation:"3 Components of US Medical-Device Regulation." Institute of Medicine. 2011. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press. doi: 10.17226/13150. × Save CancelOnce a device is designated as a restricted device, two additional important legal consequences—apart from limiting access to the device to or through physicians—result:
给他们双方接上头，咱们网友捐款，你俩负责医院拿到口罩。然后搞个清单，收到捐款数目，口罩价格，买到口罩数目，医院和供货商签字，对网友透明就行了。能买多少是多少，了却这桩心事。
我设想，供货商的可靠性由医院去决定，咱们就没这方面的责任了。
我老公说这样做的也可以的
不知道我得罪了何方神圣。那天我卖的几千个口罩才$1.81到门价，现在工厂已经涨价到13.5人民币一个了。