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Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices
Federal Register · Rule · Aug 16, 2011
Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed rule and consideration of any comments received, issue a final rule to require premarket … The comment period closed November 23, 2010. FDA received no comments on the proposed rule.
76 FR 50663Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 16, 2005
In brief, section 401 of FDAMA amended the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360aaa through 360aaa-6) to permit drug, biologic, and device manufacturers to disseminate certain written … at the end of each 6-month period), and if the volume of disseminated materials is small.
70 FR 35099Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 25, 2023
Subsequent to the close of the 60-day notice public comment period, additional comments were received from internal and external stakeholders through our solicitation of feedback external to the PRA public … comment opportunity.
88 FR 73347Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 10, 2021
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. … New Animal Drugs for Investigational Use—21 CFR Part 511 OMB Control Number 0910-0117—Extension FDA has the authority under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to approve new animal
86 FR 30953Health and Human Services DepartmentFood and Drug AdministrationRevocation of Food Standards for 11 Products Not Currently Sold
Federal Register · Rule · Jul 17, 2025
The comment period for the direct final rule runs concurrently with the companion proposed rule. … Review Act/Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801, Pub.
90 FR 33268Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jul 20, 2004
(Comment 1) One comment stated that the adjusted penalties were not severe enough to “keep crooked manufacturers from stopping their criminal acts which injure the American people.” … (1) 333(b)(2)(A) Violation of certain requirements of the Prescription Drug Marketing Act (PDMA) 50,000 For each of the first two violations in any 10-year period 2004 55,000 (2)
69 FR 43299Health and Human Services DepartmentFood and Drug AdministrationApproved Tobacco Retailer Training Program; Request for Comments
Federal Register · Notice · Dec 9, 2009
(the Tobacco Control Act). … Under each schedule, violators are subject to increasing penalties for repeated violations within prescribed time periods.
74 FR 65129Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Dec 17, 2019
for the efficient enforcement of the FD&C Act. … Mandates Reform Act of 1995 (Pub.
84 FR 68829Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 9, 2013
FDA-2013-N-0795] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act AGENCY … Third-party reviewers should maintain records of their 510(k) reviews and a copy of the 510(k) for a reasonable period of time, usually a period of 3 years.
78 FR 41065Health and Human Services DepartmentFood and Drug AdministrationFDA Modernization Act of 1997; Guidance Documents for the Medical Device Industry; Availability
Federal Register · Notice · Feb 25, 1998
After the close of the comment period, written comments may be submitted at any time to Ron Jans (address below) ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and … To submit comments after the close of the comment period contact: Ron Jans, Center for Devices and Radiological Health (HFZ-205), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301
63 FR 9570Health and Human Services DepartmentFood and Drug AdministrationFood Additives Permitted for Direct Addition to Food for Human Consumption; Olestra
Federal Register · Rule · Aug 5, 2003
The treatment periods were separated by 7-day washout periods. … Although section 409 of the act establishes no comment period for food additive petitions, and the agency generally does not solicit comments in notices announcing the filing of a food additive petition
68 FR 46364Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 27, 2013
Act) (Pub. … of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 387f(d)), as amended by the Tobacco Control Act, for retailers who have implemented a training program that complies with standards developed
78 FR 18609Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 5, 2005
Act (the act) (21 U.S.C. 360m), directing FDA to accredit persons in the private sector to review certain premarket applications and notifications. … Third-party reviews should maintain records of their 510(k) reviews and a copy of the 510(k) for a reasonable period of time, usually a period of 3 years.
70 FR 821Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 10, 2011
ACTION: Notice; request for comments. … It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments.
76 FR 27062Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 29, 2016
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk … In the Federal Register of July 26, 2016 (81 FR 48816), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
81 FR 96015Health and Human Services DepartmentFood and Drug AdministrationJason Oppenheimer: Final Debarment Order
Federal Register · Notice · Oct 1, 2025
SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jason Oppenheimer for a period of 5 years from importing or offering … In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that it considered applicable to Mr.
90 FR 47310Health and Human Services DepartmentFood and Drug AdministrationEffective Date of Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses
Federal Register · Proposed Rule · Jul 6, 2012
Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed rule and consideration of any comments received, issue a final rule to require premarket … The FD&C Act does not permit an extension of the 90-day period after issuance of a final rule within which an application or a notice is required to be filed.
77 FR 39953Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Mar 26, 2020
Paperwork Reduction Act of 1995 This guidance refers to previously approved FDA collections of information. … These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).
85 FR 17008Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 15, 2014
Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (Pub. … L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d).
79 FR 27873Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 9, 2016
As part of FDA's performance commitments, FDA is providing a period for public comment on the final assessment of the Program. … FDA will hold an open public comment period to give the public an opportunity to comment during the public meeting.
81 FR 89109Health and Human Services DepartmentFood and Drug Administration
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