FDA法规小分享

唐静波

大家一起学习FDA注册吧，我们公司有技术老师可以做国外注册，有需求的也可以找我哟
今天记录的是一些定义，做个小笔记，大家也可以一起讨论下：

• Note：If a device requires premarket notification clearance or approval it can ONLYbe listed AFTER the premarket submission [510(k), PMA, PDP, HDE] is cleared orapproved. If this is your only device listing, please do not register yourestablishment until after your premarket submission is cleared or approved.
• U.S.agent：The U.S. agent cannot use a post office box as an address. The U.S.agent cannot use just an answering service. They must be available to answerthe phone or have an employee available to answer the phone during normalbusiness hours.
• Premarketnotification – 510(k)：“Substantial Equivalence”- Compare 1) intended use; 2)device feactures; 3) performance testing.
• 510(k)：Premarket notification, for low and moderate risk devices;
• PMA：Premarket Approval Application, for highest risk devices;
• DeNovo： Device has no existing classification regulation; Marketing process fornovel devices; Alternative to PMA;
  

唐静波

• Traditional 510(k)
  

1) Required elements (21 CFR 807.87)
2) Relies on the demonstration of substantial equivalence
3) The Traditional 510(k) method can be used under any circumstance. The Abbreviated 510(k) and Special 510(k) methods can only be used if certain criteria are met.

• Abbreviated 510(k)
  

1) Required elements (21 CFR 807.87)
2) Relies on the use of guidance documents, special controls, and recognized standards
3) Under certain conditions, sponsors may not need to submit test data in an Abbreviated 510(k).

• Special 510(k) 1) Required elements (21 CFR 807.87)
  

2) Device modification to manufacturer’s own legally marketed device
3) Modification does NOT affect the intended use or fundamental scientific technology
4) No data is evaluated by FDA
If the low or moderate risk device with no identifiable predicate device: Consider de novo.