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U.S. Department of Health and Human Services

Regulatory Information

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FDAMA Implementation Chart of Completed Items

 

SECTION DESCRIPTION DOCUMENT TYPE STATUTORY DEADLINE
101 Review 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 & 2 Task

Phased in over 5 years

COMPLETED

104 Annual Report to Congress--Performance Report

Annually--60 days after end of fiscal year
12/16/1998
1/19/2000
3/19/2001

COMPLETED

104 Annual Report to Congress--Financial Report

Annually--120 days after end of fiscal year
2/16/2000
1/19/2001

COMPLETED

111 Pediatric exclusivity guidance document Guidance

None

COMPLETED
6/29/1998

Revised 10/8/1999

111** Pediatrics--list of approved drugs needing information FR Notice

May 20, 1998

Final list 
COMPLETED
5/20/1998

111** Pediatrics--study and report to Congress Task

Jan. 1, 2001

COMPLETED
January 2001

112** Fast Track--policies and procedures on fast track products Guidance

11/21/1998

COMPLETED 11/17/1998

112** Fast track--disseminate to physicians and others a description of section Task COMPLETED
(covered in previous guidance)
112** Fast track--develop program to encourage development of surrogate endpoints Task

None

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113** Draft guidance for industry on info program on clinical trials for serious or life-threatening diseases: establishment of a data bank Guidance

None
Final
3/18/2002
NIH Press Release
(2-29-2000)



113 Draft guidance on information program on clinical trials for serious or life-threatening diseases: implementation plan Guidance

None
Final
3/18/02

 

113b Feasibility of adding medical devices to clinical trial registry--report to Congress Report

None

COMPLETED
11-26-1999

114** Healthcare economic info--participate in Comptroller General study of program Task

May 21, 2002

GAO will contact FDA when it plans to start this study.

115** Women and minorities in clinical trials--develop procedures (as appropriate) Guidance

None

COMPLETED
(covered in existing guidance)

116** Changes to an approved NDA or ANDA Guidance

None

COMPLETED

116 Manufacturing changes Guidance

None

COMPLETED 10/1/1999

116** Manufacturing changes Regulation

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)

117 Streamlining clinical research--revise 312, particularly clinical holds Regulation

None

COMPLETED
Direct Final Rule: 12/14/1998

117 Submitting and reviewing complete responses to clinical holds Guidance

None

COMPLETED
5/14/1998

118** Data requirements--provide guidance on the use of abbreviated study reports in an NDA and BLA Guidance

11/21/1998
DRAFT 9/21/1998

COMPLETED 9/13/1999

119** Content and review of applications--guidance for reviewers setting standards for review Guidance

None

COMPLETED 4-27-1999
(existing guidance sufficient)

119 Formal meetings with sponsors and applicants of PDUFA products Guidance

None
Draft Published 3/19/1999

COMPLETED
Final 3/6/2000

119(a) Draft guidance for industry on special protocol assessment Guidance

None
Draft 2/8/2000

Final 5/16/2002

120 Scientific advisory panels- guidance on statutory requirements Guidance

None

COMPLETED 11/2/1998

121** PET--revoke current PET rules and policies Regulation

SD: 12/21/1997

COMPLETED 12/19/1997

121 PET--notice in FR terminating three previous docs FR Notice

12/21/1997

COMPLETED 12/19/1997

121 PET--505(b)(2) notice of safety and effectiveness FR Notice

None

COMPLETED
3/7/2000

 

122** Radiopharmaceuticals--requirements for review of radiopharmaceuticals Guidance

None

Revised Draft
7/31/2000
Notice
Guidance

COMPLETED

Final Guidances (6/22/2004)

 122** Radiopharmaceuticals--new requirements for review of radiopharmaceuticals Regulation

5/20/1999

COMPLETED
Proposed Rule
5/20/1998
Final Rule
5/17/1999

123** Biologics modernization--regulations for BLAs Regulation

None

COMPLETED (PR) 7/29/1998
FR 10/19/1999

125 Antibiotics--conforming changes to regs to delete antibiotic monographs Regulation

None

COMPLETED 5/12/1998

125 Antibiotics--antibiotic certification program Regulation

None

COMPLETED 1/5/1999

125 Insulin--Conforming changes to regs to delete insulin certification program Regulation

None

COMPLETED 5/13/1998

125 Antibiotic guidance document Guidance

None

COMPLETED 6/11/1998

125(b) Drug master files for antibiotic drug substances Guidance

None

COMPLETED 11/26/1999

126 Elimination of labeling requirements Guidance

None

COMPLETED 3/13/1998

Revised guidance COMPLETED 7/20/1998

126 Elimination of certain labeling requirements--revise 201 and 329 regarding "Rx only"/"Caution: May be Habit-Forming" labeling Regulation

None
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 compounded Regulation

None
(effective 11/21/1998)

COMPLETED(FR) 3/8/1999
Additions
(PR) 1/4/2000

127 Pharmacy compounding--establish compounding advisory committee Task

None

Notice COMPLETED 3/10/1998

127 Pharmacy compounding--Section 127 Guidance

None

COMPLETED 11/20/1998

129** Sunscreens-complete final rule Regulation COMPLETED
FR 5/21/1999
FR Amended 6/7/2000
130 Postmarketing studies--revise 314 and 601 to require annual progress reports Regulation

None

COMPLETED

Proposed Rule
11/30/1999

FR 10-26-00
Delay of Effective Date
2/16/2001
Effective Date
4/30/2001

130 Reports on status of postmarketing studies Guidance None
Draft
4/3/2001
Final Guidance
130** Postmarketing approval studies--summary of annual reports and legislative recommendations submitted to Congress Task

Annual Report
3/12/2002

COMPLETED

201** New Section in 812, allow minor manufacturing changes or minor changes to clinical protocol Regulation

11/21/1998

COMPLETED 11/20/1998

201/205 Early collaboration procedures Guidance

None

COMPLETED 2/19/98
Revised 2/28/2001

202 PMA/510(k) expedited review Guidance

None

COMPLETED 3/20/1998

203 Humanitarian use--75 day review, repeal of 18 month term Regulation

None

COMPLETED 11/3/1998
Final Rule

204 Procedures for declaration of conformity Guidance

None

COMPLETED 2/19/1998

204 List of recognized standards FR Notice

None

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

205 Evidence models for the least burdensome means to market Guidance

None

Draft
9/1/1999

205 Manufacturing changes--30-day notice; 135-day review of supplements Regulation

None

COMPLETED 10/8/1998

205 PMA supplement manufacturing changes--30- day notices Guidance

None

COMPLETED 2/19/1998

205 Scope of review--labeling changes; intended uses/510(k)s Guidance

None

COMPLETED 2/19/1998

205 Least burdensome provisions of FDAMA: concept and principles Guidance

None

Draft
5/3/ 2001
Notice Final Guidance (10/4/2002)

206 Procedures for class II exemption petitions Guidance

None

 

COMPLETED 2/19/1998

206 Codify classification regs re: exemptions, class I Regulation

None

Proposed Rule 11/10/1998

COMPLETED
Final Rule 1/13/2000

206 Codify classification regs re: exemptions, class II Regulation

None

COMPLETED
Final Rule 11/3/1998

206(c)(1)** General/specific use Guidance

8/18/1998

COMPLETED

Draft guidance 5/22/1998

Final guidance 11/4/1998

206 Day 1 guidance Guidance

None

COMPLETED 2/6/1998

  Overview of FDA Modernization Act of 1997/Medical Device Provisions Guidance

None

COMPLETED 2/19/1998

206 Class I & II exemptions from 510(k) FR Notice

1/20/1998 (Class II)

COMPLETED 1/20/1998 (Class II)

COMPLETED 2/2/1998 (Class I)

207 Content requirements for de novo classification requests Guidance

None

COMPLETED 2/19/1998

208 Amended panel procedures Guidance

None

COMPLETED 3/20/1998
Revised 7/22/2000

209 Procedures for PMA collaborative review Guidance

None

COMPLETED 2/19/1998

210 Guidance for staff, industry and third parties--implementation of third-party programs Guidance

None

COMPLETED 10/30/1998
Revised 7/17/2000
Revised 3/7/2001

210** Third party pilot--accreditation procedures FR Notice

5/20/1998

COMPLETED 5/20/1998

210** FDA accepts accredited person recommendations on 510(k)s Task

11/21/1998

COMPLETED 11/21/1998

210** Report to Congress on inclusion of certain devices within the accredited persons program--third-party review. Task

Nov. 21, 2000

COMPLETED
November 2000

210 Expand list of devices eligible for third-party review Task

None

COMPLETED 5/20/1998
Updated 2/8/1999
Updated 1/26/2001

210 List of accredited persons Task COMPLETED 10/2/1998
211 Tracking list FR Notice

None

COMPLETED
Revised 1/21/2000
Proposed Amendments
4/24/2000

212 Postmarket surveillance Regulation None
PR 8/29/2000
FR 6/6/2002
212 Guidance on procedures to determine application of postmarket surveillance strategies Guidance

None

COMPLETED 2/19/1998

212 Guidance on procedures for review of postmarket surveillance submissions Guidance

None

COMPLETED 2/19/1998
Revised 11/2/1998

212 SMDA to FDAMA: Guidance on FDA's transition plan for existing postmarket surveillance protocols Guidance

None

COMPLETED 11/2/1998

212 Criteria and approaches for postmarket surveillance Guidance

None

COMPLETED 11/2/1998

213 Reporting corrections and removals Regulation

None

COMPLETED 8/7/1998

213 Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, and distributor reporting Regulation

None

Proposed Rule
5/12/1998
Final Rule
1/26/2000Technical Amendment
5/8/2001

213(b) Establishment registration and device listing Regulation

None

COMPLETED 9/29/1998



213** Sentinel reporting Report

11/21/1999

COMPLETED 9/20/1999

216 Guidance on section 216 of FDAMA Guidance

None

COMPLETED
8/8/2000

302 Amend existing regulations on health claim and nutrient content claim petitions to make timeframes consistent with the statute Regulation

None

COMPLETED 5/14/1998

303 and 304 Notification of health claim or nutrient content claim based on authoritative statement of a scientific body Guidance

COMPLETED 6/11/1998

 

305 Amend existing regulation on referral statements on food labels Regulation

COMPLETED 5/15/1998

 

306 Amend existing regulation to conform to disclosure of radiation section--21 CFR 179.26 Regulation

None

COMPLETED 8/17/1998

306 Conf. report Act on language in conference report to publish proposed amendments to current regs relating to irradiated food Regulation

None

COMPLETED 2/17/1999

307** Make final determination on irradiation petition (to be done by regulation) Regulation

1/20/1998

COMPLETED 12/3/1997

309 Conf. report Resolve regulatory authority issues, arising from FQPA, for antimicrobials used as food contact substances (Jt. explanatory statement of the committee of conference) Task

None

COMPLETED 10/30/1998 (P.L. 105-324) and 10-9-1998

309 Create regulations to implement food contact substances premarket notification system: environmental regulations Regulation

None

Direct Final Rule
5/10/2000

COMPLETED

309 Food contact substance notification system: administrative guidance for main procedural regulation Guidance

None

COMPLETED
Draft
7/12/2000

309 Premarket notifications for food contact substances: chemistry Guidance

None

COMPLETED
Draft
11/10/1999

309 Premarket notifications for food contact substances: toxicology Guidance

None

COMPLETED
Draft
11/10/1999

309 Food contact substance notification system: main procedural regulation Regulation

Completed

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 program Report

Annually

COMPLETED

401** Information on off-label uses Regulation

11/21/1998
11/20/1998 Final Rule
(63 FR 64556)

Sunset at Sep. 30, 2006

402 Expanded access to investigational therapies and diagnostics Guidance

None

COMPLETED 2/19/1998

403(a) Supplemental applications-standards for prompt review Guidance

5/20/1998

COMPLETED 5/14/1998

403(a) Supplemental applications--standards for prompt review Notice

None

COMPLETED
FR Notice 2/7/2000

403(a)(c) Standards for prompt review of supplements FR Notice

5/20/1998

COMPLETED 5/20/1998

403(b) PMAs and PMA supplements: use of published literature, use of previously submitted materials, and priority review Guidance

5/20/1998

COMPLETED 5/20/1998

403(b)(1) Clarify circumstances for using published material as basis for approving supplemental applications FR Notice

None

COMPLETED
11/6/2000

403(b)(2) Clarify and facilitate submission of data for supplemental applications Guidance

5/20/1998

FR Notice
2/8/2000

Final Guidance 10/28/2002

403(b)** Approval of supplemental applications--complete guidance to clarify requirements for submission of supplements Guidance

5/20/1998

COMPLETED 5/15/1998

403(c)** Designate an individual to encourage prompt review of supplements and to work with sponsors Task

None

COMPLETED 2/3/1999

403(c) Designate an individual to encourage prompt review of supplements and to work with sponsors Notice

None

COMPLETED 5/21/1998

403(c) Designate an individual to encourage prompt review of supplements and to work with sponsors Notice

None

COMPLETED
FR Notice 2/7/2000

404** Dispute resolution--procedures and special advisory committee Regulation

11/21/1998

COMPLETED (FR) 11/17/1998

404 Handbook of existing appeals processes Guidance

None

COMPLETED 2/19/1998

404 Formal dispute resolution above division level Guidance

None
Draft Published 3/19/1999

COMPLETED
Final 3/6/2000

404 Draft guidance on resolving scientific disputes concerning the regulation of medical devices; administrative procedures on use of the medical devices dispute resolution panel Guidance None
Draft Published 4/27/1999
405 Training for GGPs Task None
405** Good guidance practices Regulation

July 1, 2000

COMPLETED
FR 9/18/2000

406** Agency plan for statutory compliance Report

11/21/1998

COMPLETED 11/20/1998

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

406 Mechanisms for meeting review time periods Report

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 program Task

None

COMPLETED 9/29/1999

410** Plan for mutual recognition of GMP inspections FR Notice

5/20/1998

COMPLETED 5/20/1998

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

None

COMPLETED

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

None

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

413** Mercury compounds--develop list and analysis Task

11/21/1999

COMPLETED
11/19/1999

417 Registration of foreign establishments US Agent-807.40 Regulation

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. 17 FR Notice

None

COMPLETED 10/1/1998

FR Notice


FDAMA