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  7. FDAMA Implementation Chart of Completed Items
  1. Food and Drug Administration Modernization Act (FDAMA) of 1997

FDAMA Implementation Chart of Completed Items

FDAMA Implementation Chart of Completed Items

SECTIONDESCRIPTIONDOCUMENT TYPESTATUTORY DEADLINE
101Review performance goals; meeting management goals; clinical hold responses; major dispute resolution; special protocol assignments/agreements; electronic applications and submissions; simplification of action letters; discipline reviews/IR letters; two level resubmission class 1 & 2TaskPhased in over 5 years
COMPLETED
104Annual Report to Congress--PerformanceReportAnnually--60 days after end of fiscal year
12/16/1998
1/19/2000
3/19/2001
COMPLETED
104Annual Report to Congress--FinancialReportAnnually--120 days after end of fiscal year
2/16/2000
1/19/2001
COMPLETED
111Pediatric exclusivity guidance documentGuidance

None

COMPLETED
6/29/1998
Revised 10/8/1999

111**Pediatrics--list of approved drugs needing informationFR NoticeMay 20, 1998
Final list
COMPLETED
5/20/1998
111**Pediatrics--study and report to CongressTaskJan. 1, 2001
COMPLETED
January 2001
112**Fast Track--policies and procedures on fast track productsGuidance11/21/1998
COMPLETED
11/17/1998
112**Fast track--disseminate to physicians and others a description of sectionTaskCOMPLETED
(covered in previous guidance)
112**Fast track--develop program to encourage development of surrogate endpointsTaskNone
COMPLETED
NIH/FDA Conference
April 1999
Book/Article
March 2001
113**Draft guidance for industry on info program on clinical trials for serious or life-threatening diseases: establishment of a data bankGuidanceNone
Final
3/18/2002
NIH Press Release
(2-29-2000)
113Draft guidance on information program on clinical trials for serious or life-threatening diseases: implementation planGuidanceNone
Final
3/18/02
113bFeasibility of adding medical devices to clinical trial registry--report to CongressReportNone
COMPLETED
11-26-1999
114**Healthcare economic info--participate in Comptroller General study of programTaskMay 21, 2002
GAO will contact FDA when it plans to start this study.
115**Women and minorities in clinical trials--develop procedures (as appropriate)GuidanceNone
COMPLETED
(covered in existing guidance)
116**Changes to an approved NDA or ANDAGuidanceNone
COMPLETED
116Manufacturing changesGuidanceNone
COMPLETED 10/1/1999
116**Manufacturing changesRegulation

COMPLETED

12/13/2006

Final Rule

11/21/1999
Proposed Rule 6/28/1999
(64 FR 34608)
(69 FR 18728)
Guidance (Final) 11/19/1999
Revised Guidance (4/8/2004)

117Streamlining clinical research--revise 312, particularly clinical holdsRegulationNone
COMPLETED
Direct Final Rule: 12/14/1998
117Submitting and reviewing complete responses to clinical holdsGuidanceNone
COMPLETED
5/14/1998
118**Data requirements--provide guidance on the use of abbreviated study reports in an NDA and BLAGuidance11/21/1998
DRAFT 9/21/1998
COMPLETED
9/13/1999
119**Content and review of applications--guidance for reviewers setting standards for reviewGuidanceNone
COMPLETED
4-27-1999
(existing guidance sufficient)
119Formal meetings with sponsors and applicants of PDUFA productsGuidanceNone
Draft Published 3/19/1999
COMPLETED
Final 3/6/2000
119(a)Draft guidance for industry on special protocol assessmentGuidanceNone
Draft 2/8/2000
Final 5/16/2002
120Scientific advisory panels- guidance on statutory requirementsGuidanceNone
COMPLETED
11/2/1998
121**PET--revoke current PET rules and policiesRegulationSD: 12/21/1997
COMPLETED
12/19/1997
121PET--notice in FR terminating three previous docsFR Notice12/21/1997
COMPLETED 12/19/1997
121PET--505(b)(2) notice of safety and effectivenessFR NoticeNone
COMPLETED
3/7/2000
122**Radiopharmaceuticals--requirements for review of radiopharmaceuticalsGuidanceNone
Revised Draft
7/31/2000
Notice
Guidance
COMPLETED
Final Guidances (6/22/2004)
122**Radiopharmaceuticals--new requirements for review of radiopharmaceuticalsRegulation5/20/1999
COMPLETED
Proposed Rule
5/20/1998
Final Rule
5/17/1999
123**Biologics modernization--regulations for BLAsRegulationNone
COMPLETED (PR)
7/29/1998
FR 10/19/1999
125Antibiotics--conforming changes to regs to delete antibiotic monographsRegulationNone
COMPLETED
5/12/1998
125Antibiotics--antibiotic certification programRegulationNone
COMPLETED
1/5/1999
125Insulin--Conforming changes to regs to delete insulin certification programRegulationNone
COMPLETED
5/13/1998
125Antibiotic guidance documentGuidanceNone
COMPLETED
6/11/1998
125(b)Drug master files for antibiotic drug substancesGuidanceNone
COMPLETED
11/26/1999
126Elimination of labeling requirementsGuidanceNone
COMPLETED
3/13/1998
Revised guidance COMPLETED
7/20/1998
126Elimination of certain labeling requirements--revise 201 and 329 regarding "Rx only"/"Caution: May be Habit-Forming" labelingRegulationNone
Proposed Rule
4-10-2000
Final Rule 2/1/2002
127**Pharmacy compounding--list of drugs that have been removed or withdrawn from the market that may not be compoundedRegulationNone
(effective 11/21/1998)
COMPLETED(FR) 3/8/1999
Additions
(PR) 1/4/2000
127Pharmacy compounding--establish compounding advisory committeeTaskNone
Notice COMPLETED
3/10/1998
127Pharmacy compounding--Section 127GuidanceNone
COMPLETED
11/20/1998
129**Sunscreens-complete final ruleRegulationCOMPLETED
FR 5/21/1999
FR Amended 6/7/2000
130Postmarketing studies--revise 314 and 601 to require annual progress reportsRegulationNone
COMPLETED
Proposed Rule
11/30/1999
FR 10-26-00
Delay of Effective Date
2/16/2001
Effective Date
4/30/2001
130Reports on status of postmarketing studiesGuidanceNone
Draft
4/3/2001
Final Guidance
130**Postmarketing approval studies--summary of annual reports and legislative recommendations submitted to CongressTaskAnnual Report
3/12/2002
COMPLETED
201**New Section in 812, allow minor manufacturing changes or minor changes to clinical protocolRegulation11/21/1998
COMPLETED
11/20/1998
201/205Early collaboration proceduresGuidanceNone
COMPLETED
2/19/98
Revised 2/28/2001
202PMA/510(k) expedited reviewGuidanceNone
COMPLETED
3/20/1998
203Humanitarian use--75 day review, repeal of 18 month termRegulationNone
COMPLETED
11/3/1998
Final Rule
204Procedures for declaration of conformityGuidanceNone
COMPLETED
2/19/1998
204List of recognized standardsFR NoticeNone
COMPLETED 10/16/1998
FR notice

 

7-12-1999
FR Notice
Modifications to list
11-14-2000
FR Notice
Modifications to list
5-4-2001
FR Notice
Modifications to list

205Evidence models for the least burdensome means to marketGuidanceNone
Draft
9/1/1999
205Manufacturing changes--30-day notice; 135-day review of supplementsRegulationNone
COMPLETED
10/8/1998
205PMA supplement manufacturing changes--30- day noticesGuidanceNone
COMPLETED
2/19/1998
205Scope of review--labeling changes; intended uses/510(k)sGuidanceNone
COMPLETED
2/19/1998
205Least burdensome provisions of FDAMA: concept and principlesGuidanceNone
Draft
5/3/ 2001
Notice Final Guidance (10/4/2002)
206Procedures for class II exemption petitionsGuidanceNone
COMPLETED
2/19/1998
206Codify classification regs re: exemptions, class IRegulationNone
Proposed Rule
11/10/1998
COMPLETED
Final Rule
1/13/2000
206Codify classification regs re: exemptions, class IIRegulationNone
COMPLETED
Final Rule
11/3/1998
206(c)(1)**General/specific useGuidance8/18/1998
COMPLETED
Draft guidance
5/22/1998
Final guidance
11/4/1998
206Day 1 guidanceGuidanceNone
COMPLETED
2/6/1998
 Overview of FDA Modernization Act of 1997/Medical Device ProvisionsGuidanceNone
COMPLETED
2/19/1998
206Class I & II exemptions from 510(k)FR Notice1/20/1998 (Class II)
COMPLETED
1/20/1998 (Class II)
COMPLETED
2/2/1998 (Class I)
207Content requirements for de novo classification requestsGuidanceNone
COMPLETED
2/19/1998
208Amended panel proceduresGuidanceNone
COMPLETED
3/20/1998
Revised 7/22/2000
209Procedures for PMA collaborative reviewGuidanceNone
COMPLETED
2/19/1998
210Guidance for staff, industry and third parties--implementation of third-party programsGuidanceNone
COMPLETED
10/30/1998
Revised 7/17/2000
Revised 3/7/2001
210**Third party pilot--accreditation proceduresFR Notice5/20/1998
COMPLETED
5/20/1998
210**FDA accepts accredited person recommendations on 510(k)sTask11/21/1998
COMPLETED
11/21/1998
210**Report to Congress on inclusion of certain devices within the accredited persons program--third-party review.TaskNov. 21, 2000

COMPLETED
November 2000

210Expand list of devices eligible for third-party reviewTaskNone
COMPLETED
5/20/1998
Updated 2/8/1999
Updated 1/26/2001
210List of accredited personsTaskCOMPLETED
10/2/1998
211Tracking listFR NoticeNone
COMPLETED
Revised 1/21/2000
Proposed Amendments
4/24/2000
212Postmarket surveillanceRegulationNone
PR 8/29/2000
FR 6/6/2002
212Guidance on procedures to determine application of postmarket surveillance strategiesGuidanceNone
COMPLETED
2/19/1998
212Guidance on procedures for review of postmarket surveillance submissionsGuidanceNone
COMPLETED
2/19/1998
Revised
11/2/1998
212SMDA to FDAMA: Guidance on FDA's transition plan for existing postmarket surveillance protocolsGuidanceNone
COMPLETED
11/2/1998
212Criteria and approaches for postmarket surveillanceGuidanceNone
COMPLETED
11/2/1998
213Reporting corrections and removalsRegulationNone
COMPLETED 8/7/1998
213Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, and distributor reportingRegulationNone
Proposed Rule
5/12/1998
Final Rule
1/26/2000Technical Amendment
5/8/2001
213(b)Establishment registration and device listingRegulationNone
COMPLETED
9/29/1998
213**Sentinel reportingReport11/21/1999
COMPLETED
9/20/1999
216Guidance on section 216 of FDAMAGuidanceNone
COMPLETED
8/8/2000
302Amend existing regulations on health claim and nutrient content claim petitions to make timeframes consistent with the statuteRegulationNone
COMPLETED
5/14/1998
303 and 304Notification of health claim or nutrient content claim based on authoritative statement of a scientific bodyGuidanceCOMPLETED
6/11/1998
305Amend existing regulation on referral statements on food labelsRegulationCOMPLETED
5/15/1998
306Amend existing regulation to conform to disclosure of radiation section--21 CFR 179.26RegulationNone
COMPLETED
8/17/1998
306 Conf. reportAct on language in conference report to publish proposed amendments to current regs relating to irradiated foodRegulationNone
COMPLETED
2/17/1999
307**Make final determination on irradiation petition (to be done by regulation)Regulation1/20/1998
COMPLETED
12/3/1997
309 Conf. reportResolve regulatory authority issues, arising from FQPA, for antimicrobials used as food contact substances (Jt. explanatory statement of the committee of conference)TaskNone
COMPLETED
10/30/1998 (P.L. 105-324) and 10-9-1998
309Create regulations to implement food contact substances premarket notification system: environmental regulationsRegulationNone
Direct Final Rule
5/10/2000
COMPLETED
309Food contact substance notification system: administrative guidance for main procedural regulationGuidanceNone
COMPLETED
Draft
7/12/2000
309Premarket notifications for food contact substances: chemistryGuidanceNone
COMPLETED
Draft
11/10/1999
309Premarket notifications for food contact substances: toxicologyGuidanceNone

COMPLETED
Draft
11/10/1999

309Food contact substance notification system: main procedural regulationRegulationCompleted
Proposed Rule
7/12/2000
Final Rule
5/21/2002
309**Provide reports (through FY 2003) to Congress on estimate of costs of carrying out the food contact substances notification programReportAnnually
COMPLETED
401**Information on off-label usesRegulation11/21/1998
11/20/1998 Final Rule
(63 FR 64556)
Sunset at Sep. 30, 2006
402Expanded access to investigational therapies and diagnosticsGuidanceNone
COMPLETED
2/19/1998
403(a)Supplemental applications-standards for prompt reviewGuidance5/20/1998
COMPLETED
5/14/1998
403(a)Supplemental applications--standards for prompt reviewNoticeNone
COMPLETED
FR Notice 2/7/2000
403(a)(c)Standards for prompt review of supplementsFR Notice5/20/1998
COMPLETED
5/20/1998
403(b)PMAs and PMA supplements: use of published literature, use of previously submitted materials, and priority reviewGuidance5/20/1998
COMPLETED
5/20/1998
403(b)(1)Clarify circumstances for using published material as basis for approving supplemental applicationsFR NoticeNone
COMPLETED
11/6/2000
403(b)(2)Clarify and facilitate submission of data for supplemental applicationsGuidance5/20/1998
FR Notice
2/8/2000
Final Guidance 10/28/2002
403(b)**Approval of supplemental applications--complete guidance to clarify requirements for submission of supplementsGuidance5/20/1998
COMPLETED
5/15/1998
403(c)**Designate an individual to encourage prompt review of supplements and to work with sponsorsTaskNone
COMPLETED
2/3/1999
403(c)Designate an individual to encourage prompt review of supplements and to work with sponsorsNoticeNone
COMPLETED
5/21/1998
403(c)Designate an individual to encourage prompt review of supplements and to work with sponsorsNoticeNone
COMPLETED
FR Notice 2/7/2000
404**Dispute resolution--procedures and special advisory committeeRegulation

11/21/1998

COMPLETED (FR) 11/17/1998

404Handbook of existing appeals processesGuidance

None

COMPLETED 2/19/1998

404Formal dispute resolution above division levelGuidance

None
Draft Published 3/19/1999

COMPLETED
Final 3/6/2000

404Draft guidance on resolving scientific disputes concerning the regulation of medical devices; administrative procedures on use of the medical devices dispute resolution panelGuidanceNone
Draft Published 4/27/1999
405Training for GGPsTaskNone
405**Good guidance practicesRegulation

July 1, 2000

COMPLETED
FR 9/18/2000

406**Agency plan for statutory complianceReport

11/21/1998

COMPLETED 11/20/1998

FR 11/24/1998
Correction (12/17/1998):

406Mechanisms for meeting review time periodsReport

7/1/1999

COMPLETED 7/1/1999

407**Multicenter report on information systems.Report

11/21/1998

COMPLETED 12/17/1998

408**Conduct training and education programs for employees, work with CDC on fellowship and training programs.Task

None

COMPLETED

409**Centers for Education, Research and Therapeutics (CERTS)--establish demo programTask

None

COMPLETED 9/29/1999

410**Plan for mutual recognition of GMP inspectionsFR Notice

5/20/1998

COMPLETED 5/20/1998

412National uniformity--revise part 201--labeling provisions (OTC products)Regulation

None

COMPLETED

413National uniformity--labeling provisions (OTC products)GuidanceCOMPLETED 4/9/1998
413Notice asking manufacturers to provide FDA with information on mercury compounds in drugs and foodsFR Notice

None

COMPLETED 12/14/1998
FR Notice 4/29/1999

413**Mercury compounds--develop list and analysisTask

11/21/1999

COMPLETED
11/19/1999

417Registration of foreign establishments US Agent-807.40Regulation

None

COMPLETED
PR 5/14/1999
Final rule
11/27/01

 H. Report allergenic patch test kits; requests for comments or data 105-307, Sec. 17FR Notice

None

COMPLETED 10/1/1998

FR Notice


FDAMA