Electronic Products Exemptions Found in Parts 1000 – 1040

PART 1002 RECORDS AND REPORTS

SUMMARY

Subpart A: General Provisions

Section 1002.1:  Applicability

Subpart F: Exemptions from Records and Reports Requirements

Section 1002.50:  Special exemptions

Section 1002.51:  Exemptions for manufacturers of products intended for the US Government

PART 1003 NOTIFICATION OF DEFECT OR FAILURE TO COMPLY

SUMMARY

Subpart B: Discovery of Defect or Failure to Comply

Section 1003.11:  Determination by Secretary that product fails to comply or has a defect 

Subpart D: Exemptions from Notification requirements   

Section 1003.30:  Application for exemption from notification Requirements

Section 1003.31:  Granting the exemption

PART 1010 PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL

SUMMARY

GOVERNMENT EXEMPTION DISCUSSION 

GOVERNMENT EXEMPTION CONCLUSION 

Subpart A – General Provisions

Section 1010.5:  Exemptions for products intended for United States Government use

Subpart C – Exportation of Electronic Products

Section 1010.20: Electronic products intended for export

PART 1020 PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS

SUMMARY

Section 1020.30: Diagnostic x-ray systems and their major Components

Section 1020.31: Radiographic equipment

Section 1020.32: Fluoroscopic equipment

PART 1030 PERFORMANCE STANDARDS FOR MICROWAVE and RADIO FREQUENCY EMITTING DEVICES

SUMMARY

Section 1030.10:  Microwave ovens

ATTACHMENTS

Attachment 1: Request Letter to Mr. John Villforth, Director, Bureau of Radiological Health from George Marienthal, Deputy Assistant Secretary of Defense (Environment and Safety), July 2, 1976.

Attachment 2:  Response Letter to George Marienthal, Deputy Assistant Secretary of Defense (Environment and Safety) from Mr. John Villforth, Director, Bureau of Radiological Health, July 29, 1976.

Attachment 3:  FDA Notices to the Laser Industry No. 9, “Exemption of Certain Military Laser Products from the FDA Radiation Safety Performance Standard for Laser Products”, August 23, 1975.

Attachment 4: FDA Notices to the Laser Industry No. 15, “Exemption of Certain Military Laser Products from the FDA Radiation Safety Performance Standard for Laser Products”, December 8, 1976.

Attachment 5: Response letter to George W. Siebert, Director of Safety and Occupational Health Policy, Office of the Assistant Secretary of Defense from Mr. John Villforth, Director Center for Devices and Radiological Health regarding the elimination of annual report requirement.

Attachment 6: FDA Notices to the Laser Industry No. 25, “Exemption of Certain Laser Products Used Exclusively by the Department of Energy or Its Contractors, and by the National Oceanic and Atmospheric Administration, U.S. Department of Commerce”, September 14, 1979.

Attachment 7: FDA Notices to the Laser Industry No. 52, “Guidance on the Department of Defense Exemption from the FDA Performance Standard for Laser Products (Guidance for Industry and FDA”, July 26, 2001.

Attachment 8: Federal Food Drug and Cosmetic Act,  Sections 534 (a)(5) and 538(b).

PART 1002 RECORDS AND REPORTS

SUMMARY:

Subpart A – General Provisions

Part 1002 describes the requirements of manufacturers of electronic products with respect to records and reporting.  The general provisions state that manufacturers, dealers, and distributors are subject to the provisions of Part 1002 as set forth by Table 1 – “Records and Reporting Requirements by Product.

Manufacturers may be granted an exemption by the Director, CDRH from the provisions of Part 1002 under 1002.50 and 1002.51, found in Subpart F – Exemptions from Records and Reports Requirements.

However, all manufacturers are subject to 1002.20, “Reporting of accidental radiation occurrences”.   There are no exemptions from this section, unless exempted by the Director of CDRH (see Subpart F).

Subpart F – Exemptions from Records and Reports Requirements

Section 1002.50 states that a manufacturer can request an exemption from any records and reporting requirements listed in Table 1, but the request must specify each requirement from which an exemption is requested along with a justification and supporting documentation showing that the product does not pose a public health risk.  The manufacturer must also ensure that their product meets at least one of the four criteria found in this section.

The Director, CDRH has the authority to deny or grant exemption requests from all or part of the provisions of Part 1002 provided they are in keeping with the purposes of the Act, and must provide written notification of it.  Written notification of granted exemptions must include the product or products for which the exemption was granted, the requirements from which the product is exempted, and conditions of the exemption necessary to protect public health.

The Director may also exempt certain classes of products from the requirements found in Table 1, provided the exemption is in keeping with the purposes of the Act.

Manufacturers of electronic products for which there are no applicable performance standards are also exempt from records and reporting requirements if:

a) The product was granted clinical, investigational device exemption (IDE) under Section 812.30, or

b) The product is a medical device and was granted a premarket approval (PMA) in accordance with Section 814.449(d).

There are three sections of Subchapter J which discuss exemptions for manufacturers of products intended for the U.S. Government.  Section 1002.1(c)(3) states that the requirements of Part 1002 as specified in Table 1 of that section are not applicable to manufacturers of electronic products that are intended for use by the U.S. Government and whose function or design cannot be divulged by the manufacturer for reasons of national security, as evidenced by government security classification.

Section 1002.51 states that a manufacturer may be granted an exemption from the records and reporting requirements for an electronic product intended for sole or predominant use by departments or agencies of the US government with prescribed procurement provisions which govern product radiation emissions.

Section 1010.5 specifically exempts electronic products or classes of products from provisions of performance standards for electronic products intended for use by departments or agencies of the United States.  The exemption may be granted to manufacturers, but is typically granted to U.S. Government departments or agencies, who then administer this exemption to their vendors.  This will be discussed in more detail in Part 1010.    

Links to relevant sections of 21 CFR 1002

• 21 CFR 1002

  • Subpart A—General Provisions

    • Sec. 1002.1 Applicability - See 1002.1(b)
  • Subpart F – Exemptions From Records and Reports Requirements
    • Sec. 1002.50 Special exemptions
    • Sec. 1002.51 Exemptions for manufacturers of products intended for the U.S. Government

PART 1003 NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY

SUMMARY:

Subpart B—Discovery of Defect or Failure to Comply

If the Secretary, DHHS determines that an electronic product fails to comply with 21 CFR or has a defect, he or she shall immediately notify the manufacturer in writing detailing the nature of the discovery and the methods used to detect it.  The manufacturer may present its views and evidence to rebut the notice, and will also be given an opportunity for a regulatory hearing on the matter. 

Upon receiving the notice, the manufacturer must provide production and distribution numbers of the products in question.  If after the time period specified by the notice the Secretary finds that the manufacturer is still not in compliance with 21 CFR or there is a defect, the manufacturer must notify affected people as per Section 1003.21 in 14 days unless the manufacturer has applied for an exemption from the time period specified in notification.

Subpart D – Exemptions From Notification Requirements

The Secretary may exempt a manufacturer from the original time period to present its views and present evidence in rebuttal to the notification if he or she finds that the application for a time extension is based on reasonable grounds.

If within the time extension the manufacturer proves to the Secretary's satisfaction that the defect or failure to comply does not create a significant risk of injury, including genetic injury, to any person, the Secretary shall issue an exemption from the requirement of notification to the manufacturer and shall notify the manufacturer in writing.

Links to relevant sections of 21 CFR 1003

• 21 CFR 1003

  • Subpart B—Discovery of Defect or Failure to Comply
    • Sec. 1003.11 Determination by Secretary that product fails to comply or has a defect - See 1003.11(c)
  • Subpart D – Exemptions
    • Sec. 1003.30 Application for exemption from notification requirements
    • Sec. 1003.31 Granting the exemption

PART 1010—PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL

SUMMARY:

Subpart A – General Provisions

This part describes the general performance standards for electronic products including manufacturer certification labeling of products and identification labeling of products, and instructions for determining the applicability and application for variances to the performance standards.  Performance standards for specific types of electronic products are found in Parts 1020, 1030, and 1040 for ionizing radiation emitting products, microwave and radio frequency-emitting products, light-emitting products, and sonic, infrasonic, and ultrasonic radiation-emitting products; respectively. 

Section 1010.5, describes the criteria, means, application procedures, and amendment procedures for obtaining exemptions for electronic products or class of products from the provisions of performance standards for electronic products intended for United States Government use.  The Director, CDRH may grant exemptions from any performance standard under Subchapter J of Chapter I for an electronic product or a class of electronic products when he or she determines that they are intended for sole or predominant use by departments or agencies of the United States provided:

a) The procuring agency prescribes procurement specifications for the product or class of products governing emissions of electronic radiation and these products, or

b) The product or class of products is intended for research, investigations, studies, demonstration, or training, or for reasons of national security.

This section also recommends that the US Government department or agency which intends to procure or manufacture an electronic product which must deviate from FDA regulations or standards consult with CDRH about the exemption being sought as early as possible in the development of the specifications for the product. The application for exemption must be very specific and include certain applicable elements found in this section.  Among those 13 elements is a time limit for the exemption.  Should a time limit extension or an amendment to the exemption be necessary, these can be requested through a separate application process.Once the Director has granted an exemption, a written notice specifying the exemptions and all conditions or terms will be sent to the requesting department or agency.  The department or agency will be the administrator of the exemption to the vendors.  The Director also has the authority to amend or withdraw any exemption whenever he or she determines that action is necessary to protect public health and communicated immediately to the department or agency holding the exemption.  Any equipment covered by the exemption shall also bear a specific caution label or tag stating that the equipment has been granted an exemption from 21 CFR.  See 1010.5(f) for specific language.

Subpart C--Exportation of Electronic Products

The performance standards of Part 1010 do not apply to electronic products intended solely for export, which meet all applicable requirements of the export country, and is properly labeled for export as per this section.

GOVERNMENT EXEMPTION DISCUSSION:

While government departments have been granted exemptions for laser products on a case by case basis, these will not be discussed in detail here.  This discussion will provide examples of exemptions given to departments and agencies of the United States, which have resulted in these departments and agencies administering their own exemptions for a range of laser products.  Laser industry notices which highlight key points as to their granting and enforcement will also be discussed.

Department of Defense Exemption.  The first exemption granted by the Director of the Bureau of Radiological Health (predecessor to Center for Devices and Radiological Health) was under 1010.5 Exemptions for products intended for United States Government use, and it was granted to the Department of Defense (DOD) in July 1976 (see Attachments 1 and 2).  It is identified specifically as Exemption No. 76EL-01DOD and found in Policy Statement #9, which is currently disseminated to the laser industry as FDA Notices to the Laser Industry No. 9, “Exemption of Certain Military Laser Products from the FDA Radiation Safety Performance Standard for Laser Products” (see Attachment 3). The DOD exemption was from the provisions of 21 CFR 1040.10 and 1040.11, the laser performance standards and the provisions of 21 CFR 1002, records and reporting requirements.  However, the exemption did not include 1002.20 Reporting of accidental radiation occurrences (ARO).

The basis for the request for exemption was due to labeling requirements of the laser, which did not lend themselves to DOD camouflage requirements or covert operations.  The exemption was limited only to those laser products used for combat, combat training, and classified interests of national defense. The exemption would not apply to other laser products such as those used in classroom training, demonstrations, industrial operations, scientific investigations, and medical purposes.  The Director also accepted the DOD laser user safety and control procedures as adequate.  Therefore, the exemption was granted with the following additional conditions:

1) DOD must establish monitoring procedures to assure that:

1. Only laser products designed, purchased, made, and classified by the DOD for combat, combat training operations, or in the interests of national defense conform to conditions of the exemption,
2. Permanent records will be maintained of the status of all exempted laser products, including their final disposition, and
3. The exempted products will not be disposed of through excess or surplus property channels without advance authorization by the FDA,

2) DOD will provide an annual report to FDA summarizing the internal records maintained on the exempted products identifying types of laser products and manufacturers,
3) DOD procurement specifications for such exempted products will include the radiation safety provisions of 21 CFR 1040.10 and 1040.11 to the extent practical,

4) Any substantive amendments to the radiation safety and control procedures accepted by the Director will be submitted to the FDA for review,

5) All exempted products must be clearly identified either by a specific caution label or other means as found in Attachments 2 and 3, and that a list of products identified by other than the specified caution label be included in the annual report (from DOD) along with the alternate means and the bases for such alternate means.

The exemption may be withdrawn or amended if any of these terms are not adhered to or if other information becomes available indicating that the public’s health and safety are not adequately protected from radiation emitted from exempted electronic products.

DOD Exemption in Practice.  Five months later in December 1976, it became known to FDA that manufacturers of certain laser products for the DOD were claiming exemptions from 21 CFR 1410.10 and 1410.11 citing Policy Statement #9 (Attachment 3).  Upon contacting the DOD, FDA learned that procedures for processing exemptions had not been implemented as of December 7, 1976 nor had DOD authorized an exemption for any laser product.  

Therefore, FDA issued Policy Statement #15, which is currently disseminated to the laser industry as FDA Notices to the Laser Industry No. 15, “Exemption of Certain Military Laser Products from the FDA Radiation Safety Performance Standard for Laser Products” (see Attachment 4) In this statement, manufacturers were instructed to secure a written confirmation of their exemption from the DOD along with terms of the exemption for their specific laser products.  All non-exempted laser products manufactured on or after August 2,1976 had to be certified by their manufacturers in compliance with 21 CFR 1040.10 and 1040.11. Manufacturers in violation of these requirements may have been subjected to penalties described by Section 360C (most likely updated to Section 303) of the Act.  The statement also ordered that the introduction of all military laser products into general commerce which were not in compliance with the Federal standard be terminated immediately until an exemption authorization was secured from DOD.

DOD Exemption Amendment.  In January 1986, DOD requested an amendment to exemption 76EL-01DOD, which would eliminate the annual report requirement. At the time the exemption was granted, the performance standard for light-emitting products (Section 1040) had not yet been in effect, and the Director retained the annual report requirement as a prudent measure to assure public health without being able to reasonably foresee the magnitude of potential problems and challenges associated with the performance standard. 

After 10 years of experience administering these regulations and receiving 9 annual reports from DOD, the Director decided that annual reports were no longer needed as a monitoring tool and revoked the annual report requirement effective September 1, 1985.  However, while annual reports were no longer required, the information contained in the annual reports must still be collected and maintained, as this information may be requested by FDA to verify manufacturer DOD exemption claims (See Attachment 5).

2002 DOD Exemption Guidance. In July 2002, a guidance document was written to laser manufacturers regarding DOD exemption 76EL01DOD and was disseminated to the laser industry as FDA Notices to the Laser Industry No. 52, “Guidance on the Department of Defense Exemption from the FDA Performance Standard for Laser Products (Guidance for Industry and FDA” (see Attachment 6).  The purpose of this guidance document was to clarify and update the conditions for the DOD guidance procured for combat or combat training, or that are for reasons of national security.  This guidance was directed specifically to manufacturers regarding the DOD exemption, supplements Laser Notices #9 and #15, and identifies the current military services resources for the administration of this exemption. 

The coordinating group for laser safety issues within the DOD is the Laser Systems Safety Working Group (LSSWG).  The LSSWG was concerned that laser products were offered to various DOD purchasing authorities and procured without appropriate control measures implemented to assure the safest possible use.

The guidance consists of three basic precepts:

1) Manufacturers must obtain an exemption letter from an authorized DOD procurement office and retain it for subsequent sales. 

2) Any subsequent modification to a military exempt laser product by the manufacturer requires a new DOD exemption letter.  Any manufacturer selling a product that is not FDA compliant to the DOD or falsely labels a laser product as exempt without a DOD exemption letter is in violation of Federal law; and

3) Once the DOD exemption is applied to a laser system, the system cannot be sold, surplused, or distributed to organizations outside the DOD, unless it fully complies with FDA regulations in 21 CFR.

DOE and NOAA Exemptions.  Robert Britain, Director of Compliance, Bureau of Radiological Health approved an exemption for the Department of Energy (DOE) in 1978 and the National Oceanic and Atmospheric Administration (NOAA) in 1979 under Section 1010.5. These exemptions were identified specifically as Nos. 78EL-01DOE, and 79EL-01NOAA for DOE and NOAA, respectively. Both exemptions were the subject of Policy Statement #25, which was disseminated as a memorandum to the laser industry as FDA Notices to the Laser Industry No. 25, “Exemption of Certain Laser Products Used Exclusively by the Department of Energy or Its Contractors, and by the National Oceanic and Atmospheric Administration, U.S. Department of Commerce” (see Attachment 7). These exemptions are for exclusive use by NOAA and DOE or its contractors at DOE designated, government-owned, contractor-operated facilities in unique research applications or as components in larger research and development systems.  The exemptions are from the provisions of the laser products performance standard, 21 CFR 1040.10 and 1040.11 and associated reporting and recordkeeping requirements of 21 CFR 1002 with the exception of 1002.20 relating to accidental radiation occurrences.

As conditions of the exemptions, all exempted products are to be clearly identified by legible labels or inscriptions upon final assembly as per wording set forth in the exemption letter. Additionally, DOE and NOAA will report annually to FDA on the type of devices procured under the exemption and their manufacturers. Finally, the exemption may be withdrawn or amended if any of the terms of the agreement between FDA and these agencies are not adhered to.

GOVERNMENT EXEMPTION CONCLUSION:

Exemptions have been granted to the Government departments and agencies who requested them under 1010.5, and DOD, DOE, and NOAA became the administrators of their exemptions to the vendors from whom electronic products would be procured.  The DOD exemption letter is readily available, and it outlines the conditions under which their exemption is granted.  Laser Notices 9, 15, and 52 communicate information about the DOD exemption and how it affects manufacturers.  Similarly, Laser Notice 25 communicates updated information about the DOE and NOAA exemptions to manufacturers. 

One item missing from both the DOD exemption request letter and the FDA letter granting the exemption was the period of time the exemption was to be in effect, but the inference from the letter was that it would be indefinite.  

Evidence to date states that all original exemptions contain language requiring these Government agencies and departments to furnish annual reports summarizing the internal records maintained on the exempted products, identifying types of laser products and manufacturers (including those manufactured by the government departments and agencies) as well as a list of those products which are identified by means other than the label and wording specified by the exemption, and if different, information that forms the basis for different means of identification.  Additionally, any substantive amendments to the radiation safety procedures enclosed in the exemption request letter must be submitted to FDA for review.  

Links to relevant sections of 21 CFR 1010

• 21 CFR 1010

  • Subpart A – General Provisions
    • Sec. 1010.5 Exemptions for products intended for United States Government use
  • Subpart C -  Exportation of Electronic Products
    • Sec. 1010.20 Electronic products intended for export

PART 1020 – PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS

SUMMARY:

Sec. 1020.30 Diagnostic x-ray systems and their major components.

(q) Modification of certified diagnostic x-ray components and systems.

Certified diagnostic x-ray comp components and systems in accordance with 1010.2 of this chapter may only be modified if a variance has been granted or an exemption under Section 534(a)(5) or 538(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) has been granted (see Attachment 8). 

Sec. 1020.31 Radiographic equipment. 

This exemption is for radiation therapy simulation systems from the visual definition requirement of this section.

Sec. 1020.32 Fluoroscopic equipment. 

(a)Primary protective barrier

Radiation therapy simulation systems shall be exempt from the limitation of useful beam requirement provided the systems are intended only for remote control operation and the manufacturer sets forth instructions for assemblers with respect to control location as part of the information, and the manufacturer provides precautions concerning the importance of remote control operation to users.

(d)Air kerma rates.

Fluoroscopic radiation therapy simulation systems are exempt from the requirements set forth in this section.

Links to relevant sections of 21 CFR 1020

• 21 CFR 1020

  • Sec. 1020.30 Diagnostic x-ray systems and their major components - See 1020.30(q)(1)
  • Sec. 1020.31 Radiographic equipment - See 1020.31(d)(2)(ii)
  • Sec. 1020.32 Fluoroscopic equipment - See 1020.32(a)(1) and (d)(4)

PART 1030 – PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS

SUMMARY:

Sec. 1030.10 Microwave ovens.

(c) Requirements

(6) Warning labels.

Upon application, the Director, CDRH may grant an exemption from one or more of the statements (radiation safety warnings) specified in this paragraph and it must be based upon a determination by the Director that the microwave oven model for which the exemption is sought should continue to comply with paragraphs (c) (1), (2), and (3) of this section under the adverse condition of use addressed by such precautionary statement(s).

Links to relevant sections of 21 CFR 1030

• 21 CFR 1030
  • Sec. 1030.10 Microwave ovens - See 1030.10(c)(6)(iv)