Overview of FDA’s Device Regulations

April 23, 2003

FDA`s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions.

Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval. A description of device classification and a link to the Product Classification Database can be found at: http://www.fda.gov/cdrh/devadvice/313.html

The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are:

  • Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA),
  • Establishment registration on form FDA-2891,
  • Medical Device Listing on form FDA-2892,
  • Quality System (QS) regulation,
  • Labeling requirements, and
  • Medical Device Reporting (MDR)
Premarket Notification 510(k) – 21 CFR Part 807 Subpart E

If your device requires the submission of a Premarket Notification 510(k) you can not commercially distribute the device until you receive a letter of substantial equivalence from FDA authorizing you to do so. A 510(k) must demonstrate that the device is substantially equivalent to one legally in commercial distribution in the United States: (1) before May 28, 1976; or (2) to a device that has been determined by FDA to be substantially equivalent. Information on preparing a 510(k) submission can be found at: http://www.fda.gov/cdrh/devadvice/314.html.

On October 26, 2002 the Medical Device User Fee and Modernization Act of 2002 became law. It authorizes FDA to charge a fee for medical device Premarket Notifcation 510(k) reviews. A small business may pay a reduced fee. (Please note that a reduced fee for small businesses is not available in fiscal year 2003.) The payment of a premarket review fee is not related in any way to FDA’s final decision on a submission.

For fiscal year 2003 (October 1, 2002 through September 30, 2003), the fee for 510(k) review is $2187. The application fee applies to Traditional, Abbreviated, and Special 510(k)s. Additional information on medical device user fees, including how to qualify as a small business, is available at http://www.fda.gov/cdrh/devadvice/314a.html. Please note that FDA policy on issues related to medical device user fees is still under development. FDA will post policy issues with respect to user fees on the user fee website as it becomes available.

Most Class I devices and some Class II devices are exempt from the Premarket Notification 510(k) submission. A list of exempt devices is located at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm

If you plan to send a 510(k) application to FDA for a Class I or Class II device, you may find 510(k) review by an Accredited Persons beneficial. FDA accredited 12 organizations to conduct a primary review of 670 types of devices. By law, FDA must issue a final determination within 30 days after receiving a recommendation from an Accredited Person. You can find information on the Accredited Persons Program at http://www.fda.gov/cdrh/thirdparty. Please note that 510(k) review by an Accredited Person is exempt from any FDA fee; however, the third-party may charge a fee for its review.

Premarket Approval (PMA) – 21 CFR Part 814

Product requiring PMAs are Class III devices are high risk devices that pose a significant risk of illness or injury, or devices found not substantially equivalent to Class I and II predicate through the 510(k) process. The PMA process is more involved and includes the submission of clinical data to support claims made for the device. The PMA is an actual approval of the device by FDA. A description of the process and instructions for filing a PMA application can be found at: http://www.fda.gov/cdrh/devadvice/pma/.

Beginning fiscal year 2003 (October 1, 2002 through September 30, 2003), medical device user fees apply to original PMAs and certain types of PMA supplements. Small businesses are eligible for reduced or waived fees. Additional information on medical device user fees, including how to qualify as a small business, is available at http://www.fda.gov/cdrh/devadvice/pma/userfees.html. Please note that FDA policy on issues related to medical device user fees is still under development. FDA will post policy issues with respect to user fees on the user fee website as it becomes available.

Investigational Device Exemption (IDE) – 21CFR Part 812

Clinical trials using unapproved medical devices on human subjects are performed under an Investigational Device Exemption (IDE). Clinical studies with devices of significant risk must be approved by FDA and by an Institutional Review Board (IRB) before the study can begin. Studies with devices of nonsignificant risk must be approved by the IRB only before the study can begin.

A description of the IDE process and information on FDA requirements for conducting a clinical study of an unapproved medical device can be found at: http://www.fda.gov/cdrh/devadvice/ide/index.shtml

Establishment Registration form FDA-2891 – 21 CFR Part 807

Manufacturers (both domestic and foreign) and initial distributors (importers) of medical devices must register their establishments with the FDA. A description of the establishment registration process and instructions for completion of the Establishment Registration form FDA-2891 can be found at: http://www.fda.gov/cdrh/devadvice/341.html

Once a year, FDA sends the registration form FDA-2891(a) to all registered firms to be verified, corrected, and returned by the firm as a yearly registration.

In addition to registration, foreign manufacturers must also designate a U.S. Agent. Information on U.S. Agents can be found at http://www.fda.gov/cdrh/usagent/

Medical Device Listing form FDA-2892 – 21CFR Part 807

All medical devices that are manufactured and imported into the U.S. are required to be listed with the FDA on Medical Device Listing form FDA-2892. Firms that are required to list their devices are those that:

  • manufacture,
  • repackage and relabel,
  • develop specifications,
  • reprocess single-use devices,
  • remanufacture
  • manufacture accessories and components sold directly to the end user

A separate device listing form must be submitted for each type of device.

A description of the medical device listing process and instructions for how to obtain and submit a device listing for your firm can be found at: http://www.fda.gov/cdrh/devadvice/342.html

Quality System Regulation (QS)/Good Manufacturing Practices (GMP) – 21 CFR Part 820

The quality system regulation includes requirements related to the methods used in and the facilities and controls used for: designing, purchasing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices. Manufacturing facilities undergo FDA inspections to assure compliance with the QS requirements.

The quality system regulation includes design controls which must complied with during the design and development of the device. Information on design controls can be found in the following guidance documents:

Design Control Guidance for Medical Device Manufacturers

Do It By Design – An Introduction to Human Factors in Medical Devices

The guidance document, “Medical Device Quality Systems Manual: A Small Entity Compliance Guide” is available on the Internet at: http://www.fda.gov/cdrh/dsma/gmpman.html

Additional information on the QS requirements can be found at the following websites:
http://www.fda.gov/cdrh/devadvice/32.html or http://www.fda.gov/cdrh/dsma/cgmphome.html.

Labeling – 21 CFR Part 801

Labeling includes labels on the device as well as descriptive and informational literature that accompanies the device. Labeling requirements can be accessed on the web at: http://www.fda.gov/cdrh/devadvice/33.html

Medical Device Reporting – 21 CFR Part 803

Incidents in which a device may have caused or contributed to a death or serious injury must to be reported to FDA under the Medical Device Reporting program. In addition, certain malfunctions must also be reported. The MDR regulation is a mechanism for FDA and manufacturers to identify and monitor significant adverse events involving medical devices. The goals of the regulation are to detect and correct problems in a timely manner. Further information on the Medical Device Reporting process can be found at: http://www.fda.gov/cdrh/devadvice/351.html

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA)

On October 26, 2002 the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) became law. MDUFMA amends the Federal Food, Drug and Cosmetic (FFD&C) Act to provide FDA important new responsibilities, resources, and challenges. MDUFMA has three particularly significant provisions:

  • User fees for premarket reviews;
  • Establishment inspections may be conducted by accredited persons (third-parties);
  • New regulatory requirements for reprocessed single-use devices.

On November 7, 2002 the Center for Devices and Radiological Health created a new website at www.fda.gov/cdrh/mdufma/index.html that is dedicated to MDUFMA. Included on this website are links to reference materials and background information on MDUFMA, including a full text of the law, summary of the law, and the Legislative History of MDUFMA. In addition there is a Frequently Asked Questions (FAQ) document, which should help you address questions you may have regarding the new law. As FDA proceeds with implementation of MDUFMA, CDRH expects to update the website regularly.

On February 4, 2003 the FDA published a notice in the Federal Register (FR) announcing the establishment of a public docket to provide an opportunity for all interested persons to provide information and share views on the implementation of MDUFMA. Comments, written or electronic, may be submitted at any time. The address on where to send these comments and the MDUFMA docket number can be found in the FR notice at: http://www.fda.gov/OHRMS/DOCKETS/98fr/03-2604.htm

The FDA updated this article on April 23, 2003.