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US FDA Good Guidance Practices (GGP) Documents
Radsafers,
The following is extracted from the US Food and Drug
Administration's Web site at URL:
http://www.fda.gov/cdrh/ggpmain.html
Several of these documents (there are many more than
shown here) are of relevance to the radiation protection
community, though some are moving into the "out-of-date"
zone.
S.,
MikeG.
----------
Good Guidance Practices (GGP) Documents
The following is the current comprehensive list of all CDRH
guidance documents. The term guidance document refers to
documents prepared for CDRH staff, regulated industry and
the public that relate to either: the processing, content,
and evaluation of regulatory submissions; the design,
production, manufacturing, and testing of regulated products;
or inspection and enforcement procedures. Guidance documents
do not create or confer any rights for or on any person and
do not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the
requirements of the applicable statue, regulations, or both.
Some of these documents exist on the Web and a link to them
has been established. In the future, links to all of these
documents will be made available. Documents listed below with
a document number can be requested using the CDRH Facts-On
Demand (FOD) system by dialing 800-899-0381. Information
regarding the GGP procedures can be found in the Federal
Register notice of February 27, 1997, (62 FR 8961) entitled
The Food and Drug Administration's Development, Issuance, and
Use of Guidance Documents.
DOCUMENT TITLE DOC # DATE OFFICE
...
Clarification of Radiation Control
Regulations for Diagnostic X-Ray
Equipment (FDA 89-8221) 758 3/1/89 OC\DOEI
A Guide for the Submission of
Abbreviated Radiation Safety
Reports on Cephalometric X-Ray
Devices: Defined as Dental Units
with an Attachment for Mandible
Work that Holds a Cassette and
Beam Limiting Device 977 3/1/96 OC\DOEI
A Guide for the Submission of
Abbreviated Radiation Safety
Reports on Image Receptor Support
Devices for Mammographic X-Ray
Systems 979 3/1/96 OC\DOEI
"A Guide for the Submission of an
Abbreviated Radiation Safety
Report on X-Ray Tables, Cradles,
Film Changers or Cassette Holders
Intended for Diagnostic Use" 978 3/1/96 OC\DOEI
"All Diagnostic Ultrasound
Manufacturers and
Importers-Exemption from
Reporting under 21 CFR 1002," 313 2/24/86 OC\DOEI
Guide for the Submission of Initial
Reports on Diagnostic X-Ray
Systems and their Major
Components 257 1/1/82 OC\DOEI
...
Manufacturers/Assemblers of
Diagnostic X-ray Systems:
Enforcement Policy for
Positive-Beam Limitation (PBL)
Requirements in 21 CFR 1020.31(g) 116 10/13/93 OC\DOEI
...
Letter to Ophthalmologists about
Lasers for Refractive Surgery 6/27/97 OC\DOEII
...
Manufacturers and Users of Lasers
for Refractive Surgery 10/10/96 OC\DOEII
...
Guide for Preparing Product
Reports for Lasers and Products
Containing Lasers 277 9/1/95 OC\DOEII
...
Compliance Guide for Laser
Products (FDA 86-8260) 278 9/1/85 OC\DOEII
...
Open Door Operation of Microwave
Ovens as a Result of Oven
Miswiring 646 3/28/80 OC\DOEIII
Guide for Preparing Abbreviated
Reports of Microwave and RF
Emitting Electronic Products
Intended for Medical Use 399 9/1/96 OC\DOEIII
...
"Abbreviated Reports on Radiation
Safety for Microwave Products
(Other Than Microwave Ovens)- E.G.
Microwave Heating, Microwave
Diathermy, RF Sealers, Induction,
Dielectric Heaters, Security
Systems" 236 8/1/95 OC\DOEIII
...
Abbreviated Reports on Radiation
Safety of Non-Medical Ultrasonic
Products 951 8/1/95 OC\DOEIII
...
Guidance for the Submission of
Cabinet X-Ray System Reports
Pursuant to 21-CFR 1020.40 241 2/1/75 OC\DOEIII
Guide for Preparing Annual Reports
on Radiation Safety Testing of
Electronic Products (General) 243 10/1/87 OC\DOEIII
...
Guide for Preparing Annual Reports
on Radiation Safety Testing of
Sunlamps and Sunlamp Products
(replaces FDA 82-8127) 262 9/1/95 OC\DOEIII
Guide for Preparing Product
Reports on Sunlamps and Sunlamp
Products (21-CFR 1002) 279 9/1/95 OC\DOEIII
Guide for Preparing Reports on
Radiation Safety of Microwave
Ovens 239 3/1/85 OC\DOEIII
Guide for Submission of
Information on Accelerators
Intended to Emit X-Radiation
Required Pursuant to 21-CFR
1002.10 235 4/1/71 OC\DOEIII
Guide for Submission of
Information on Analytical X-Ray
Equipment Required Pursuant to
21-CFR 1002.10 240 4/30/74 OC\DOEIII
Guide for Submission of Information
on Industrial Radiofrequency
Dielectric Heater and Sealer
Equipment Pursuant to 21 CFR
1002.10 and 1002.12 (FDA 81-8137) 254 9/1/80 OC\DOEIII
Guide for Submission of Information
on Industrial X-Ray Equipment
Required Pursuant to 21-CFR
1002.10 237 3/1/73 OC\DOEIII
Guide for the filing of Annual
Reports for X-Ray Components and
Systems 253 7/1/80 OC\DOEIII
Guide for the Submission of
Initial Reports on Computed
Tomography X-Ray Systems 271 9/1/84 OC\DOEIII
...
Imports Radiation-Producing
Electronic Products (FDA 89-8008) 756 11/1/88 OC\DOEIII
...
"Reporting and Compliance Guide
for Television Products including
Product Report, Supplemental
Report, Radiation Safety
Abbreviated Report, Annual
Report, Information and Guidance" 260 10/1/95 OC\DOEIII
...
Revised Guide for Preparing Annual
Reports on Radiation Safety
Testing of Laser and Laser Light
Show Products (replaces FDA
82-8127) 264 9/1/95 OC\DOEIII
...