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Mber 0910 0078; the collections of information in 21 CFR part 807, subpart E have been approved under OMB control number 0910 0120; the collections of information in 21 CFR part 814, subpart B have been approved under OMB control number 0910 0231; and the collections of information under 21 CFR part 801 have been approved under OMB control number 0910 0485. XI. Proposed Effective Date FDA is proposing that any final rule based on this proposal become effective on the date of its publicat.

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Preamendments Related content

102 PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS
shall include a copy of the most cur- rent status report submitted to the agency under...
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Clinical Trials Registration and Results...
Sep 21, 2016 — This final rule details the requirements for submitting registration and...
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Bioresearch Monitoring - Chapter 48
Sep 26, 2018 — (see 21 CFR Part 812). a. Determine if the IRB is reviewing any such...
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21 CFR 312.60 An investigator is responsible for ensuring that an investigation is conducted ing to the signed investigator statement (the FDA's 1572 form), the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the ...

Under 21 CFR 312.32(c), as it currently exists, a sponsor must provide expedited reporting to FDA and to all participating investigators of any “suspected adverse reaction that is both serious and unexpected” (a serious and unexpected suspected adverse reaction (SUSAR)).

Title 21 of the CFR is reserved for rules of the Food and Drug Administration. Each title (or volume) of the CFR is revised once each calendar year.

21 CFR Part 11 provides an opportunity for medical device companies to reap the organizational benefits of paperless record-keeping systems. It also helps the FDA ensure that when medical device companies use electronic record-keeping systems, that document security and authenticity are adequately maintained.

21 CFR Part 11 is a U.S. federal regulation specifying FDA guidelines for electronic Records and Signatures. The regulation applies to pharmaceutical companies and medical device manufacturers, and it requires the companies to implement controls that ensure the integrity of their documents.

(a) This part contains procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the Food and Drug Administration of investigational new drug applications (IND's).

The purpose of an IDE under 21 CFR Part 812 is to encourage the discovery and development of useful devices, with the proviso that “protection of the public health and safety” is preserved. FDA wants revolutionary new devices to be tested, as long as safety and ethics are kept a priority.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232