FDA Electronic Device Compliance

FDA Compliance Lawyers for Electronic Device Manufacturers, Importers, and Other Companies

**Attorney Nick Oberheiden**
FDA Electronic Device Compliance Team Lead

**Attorney Lynette Byrd**
FDA Electronic Device Compliance Team Lead
Former DOJ Attorney

Attorney John Sellers — **John W. Sellers**
FDA Electronic Device Compliance Team Lead
Former Senior DOJ Trial Attorney

The U.S. Food and Drug Administration (FDA) regulates radiation-emitting electronic devices under the Health and Safety Act of 1968. Its regulatory jurisdiction extends to all industries—from consumer electronics to medical equipment and airport screening technology. While the FDA’s jurisdiction in this area is limited to electronics “manufacturers,” this term is defined broadly to include importers, assemblers, and a variety of other companies.

Electronic devices that are subject to the FDA’s oversight include all devices sold in the U.S. that are radiation emitting electronic products. This includes: (i) ionizing electromagnetic or particulate radiation; (ii) non-ionizing electromagnetic radiation; and, (iii) sonic, infrasonic, and ultrasonic waves. If a product qualifies as a radiation-emitting electronic device and also qualifies as another type of FDA-regulated product (i.e., medical devices), then the product is subject to both applicable sets of laws, rules, and regulations.

Experienced FDA Compliance Counsel for Electronic Device Companies in the U.S. and Abroad

We provide comprehensive FDA electronics compliance services to manufacturers and other companies throughout the United States and worldwide. Our FDA compliance lawyers and consultants have extensive experience, including prior experience inside the FDA and other federal agencies. From developing custom-tailored policies and procedures to communicating with the FDA, we assist our clients with all aspects of compliance, and we are available to provide representation for FDA inspections, investigations, and enforcement proceedings as needed.

3 Key Areas of FDA Electronic Device Compliance

For electronic device manufacturers (as defined by the FDA), there are three key areas of FDA compliance. Each area requires equal focus and attention, as any compliance failure has the potential to trigger scrutiny from the FDA or its Center for Devices and Radiological Health (CDRH). The three key areas of FDA compliance for electronic device manufacturers are:

1. Performance Standards

Radiation-emitting electronic devices manufactured and sold in the United States must meet the FDA’s performance standards for radiation control. These standards are outlined in 21 C.F.R. Sections 1010 to 1050, and they establish requirements pertaining to the design, testing, and labeling of covered devices that emit radiation. This includes (but is by no means limited to) devices such as:

Body and baggage screening devices
Cell phones and other wireless devices
Laser-equipped devices
Microwaves
Sunlamps and tanning beds
Ultrasound devices
MRI and CT systems
Radiation therapy systems
Surgical lasers
X-ray systems

As explained in 21 C.F.R. Section 1010.2, “[e]very manufacturer of an electronic product for which an applicable standard is in effect . . . shall furnish to the dealer or distributor, at the time of delivery of such product, the certification that such product conforms to all applicable standards under this subchapter.” Thus, compliance with all applicable performance standards is a prerequisite for self-certification, which is the second key area of FDA electronic device compliance.

2. Self-Certification

All FDA-regulated electronic devices must be certified prior to distribution for sale in the United States. This is a self-certification process—the FDA does not clear or approve radiation-emitting electronic devices (unless these devices are also subject to the FDA’s medical device regulations). As further explained in 21 C.F.R. Section 1010.2:

“[C]ertification shall be based upon a test, in accordance with the standard, of the individual article to which it is attached or upon a testing program which is in accordance with good manufacturing practices. The [CDRH] may disapprove such a testing program on the grounds that it does not assure the adequacy of safeguards against hazardous electronic product radiation or that it does not assure that electronic products comply with the standards prescribed under this subchapter.”

The FDA’s electronic device regulations also allow for self-certification by other means when warranted, though here CDRH approval is required. Laser systems and certain other types of radiation-emitting electronic devices are subject to more stringent testing and self-certification requirements as well.

3. Record keeping and Reporting to the FDA

Electronic device manufacturers that are subject to the FDA’s oversight must also comply with the Administration’s record keeping and reporting requirements. Manufacturers must maintain records that are sufficient to demonstrate compliance with the applicable performance standards and certification requirements, and they must submit both initial and annual electronic product reports to the FDA.

Submitting an initial report is a prerequisite for bringing a new radiation-emitting electronic device to market. Manufacturers’ initial reports must include information sufficient to demonstrate compliance with the applicable performance standards and certification requirements, including:

The device’s radiation safety and effectiveness data specifications
The device’s labeling
Information about the manufacturer’s quality control testing program

Annual reports are due on September 1 for the prior one-year period from July 1 to June 30. Manufacturers’ annual reports must contain complete and accurate disclosures of information including (but not limited to):

Annual production data
Compliance testing results
Radiation concerns and consumer safety inquiries

Comprehensive FDA Compliance Services for Electronic Device Manufacturers

We assist electronic device manufacturers with FDA compliance throughout the product lifecycle. Our lawyers and consultants help manufacturers develop compliance testing and self-certification procedures, and we assist our clients with preparing compliant initial and annual reports for submission to the FDA. We also assist with ongoing compliance testing, market surveillance, recordkeeping, and all other necessary aspects of managing an FDA electronic device compliance program. Several members of our team have specific experience advising medical device manufacturers, and we can assist with all aspects of medical device compliance (including pre-market submissions) as well.

Our FDA compliance services for electronic device manufacturers include:

Drafting and implementation of FDA compliance policies and procedures
Internal FDA electronic device compliance training
Adherence to applicable FDA performance standards for radiation-emitting electronic devices
Development of compliant electronic device testing protocols and procedures
Radiation emission testing data analysis and reporting
FDA self-certification for radiation-emitting electronic devices
Recordkeeping for purposes of FDA compliance and reporting
Preparation and submission of initial and annual FDA electronic device reports
Ongoing compliance testing, market surveillance, and safety inquiry investigation and response
Defense against FDA inspections, investigations, and enforcement proceedings

We custom-tailor our FDA compliance services to individual manufacturers’ specific obligations and needs. Manufacturers’ obligations can vary widely based on the scope of their operations and the specific radiation-emitting products they sell. Our lawyers and consultants have an in-depth understanding of the FDA’s requirements and expectations, and we rely on this understanding to provide targeted, efficient, and cost-effective compliance representation.

Dr. Nick Oberheiden

Founder

Attorney-at-Law

Lynette S. Byrd

Former DOJ Trial Attorney

Partner

Brian J. Kuester

Former U.S. Attorney

Hon. Kevin McCarthy

55th Speaker, U.S. House of Representatives (ret.)

Government Consultant

Mike Pompeo

Of Counsel

Former U.S. Secretary of State

John W. Sellers

Former Senior DOJ Trial Attorney

Linda Julin McNamara

Federal Appeals Attorney

Nicholas B. Johnson

Former Prosecutor

Roger Bach

Former Special Agent (DOJ)

Chris J. Quick

Former Special Agent (FBI & IRS-CI)

Michael S. Koslow

Former Supervisory Special Agent (DOD-OIG)

Ray Yuen

Former Supervisory Special Agent (FBI)

FAQs: The FDA’s Regulation of Radiation-Emitting Electronic Devices

When Are Electronic Devices Subject to FDA Compliance?

Electronic devices are subject to FDA compliance when they emit ionizing, non-ionizing, sonic, infrasonic, or ultrasonic radiation. This applies to all types of products and equipment, from consumer electronics like microwave ovens to class II devices like blood pressure cuffs. Manufacturers must test their devices to determine what level of radiation they emit, and then they must take all necessary steps to comply with the applicable laws, rules, and regulations.an Investigational Device Exemption allows the device to be used in a clinical study to collect safety and effectiveness data ahead of approval from the FDA.

What Do Electronic Device Manufacturers Need to Do to Manage FDA Compliance Effectively?

For electronic device manufacturers, effectively managing FDA compliance starts with ensuring that their devices meet the applicable performance standards. Once their devices are compliant, manufacturers must then self-certify compliance before distributing their products for sale. Manufacturers of radiation-emitting electronic devices must meet FDA reporting requirements as well.

What Are the Risks of FDA Noncompliance for Electronic Device Manufacturers?

The risks of FDA noncompliance for electronic device manufacturers are many and varied. Noncompliant devices may be subject to voluntary or mandatory recalls, and the FDA may take additional enforcement action as well. Knowingly selling noncompliant radiation-emitting devices can even lead to criminal enforcement in some cases. Selling noncompliant devices presents civil liability risks as well, and manufacturers that sell dangerous radiation-emitting devices can face substantial damages in class action litigation.

What if My Company Manufacturers a Medical Device that Also Qualifies as an Electronic Device?

If your company sells a medical device that also qualifies as an electronic device under the FDA’s regulations, then the device must comply with both the FDA’s medical device and electronic device requirements. While the medical device requirements are more onerous in many respects (particularly for Class III devices), electronic device compliance presents its own unique set of challenges and must not be overlooked. At Oberheiden P.C., we provide full-service FDA compliance representation for medical device manufacturers.

Do I Need to Engage a Law Firm for FDA Electronic Device Compliance?

Due to the complexities of FDA electronic device compliance (and the potential ramifications of noncompliance), companies should engage experienced counsel to assist them with developing and implementing an effective compliance program. At Oberheiden P.C., we assist manufacturers of all sizes with all aspects of FDA compliance, and we develop custom-tailored solutions that are designed to help our clients efficiently meet all pertinent legal and regulatory requirements.

Speak with a Senior Lawyer at Oberheiden P.C. About FDA Electronic Device Compliance

Do you need to know more about FDA electronic device compliance? Do you have questions or concerns about your company’s FDA compliance program needs? If so, we invite you to get in touch. To speak with a senior FDA compliance lawyer at Oberheiden P.C. in confidence, please call 888-680-1745 or request a complimentary initial consultation online today.