Skip to main content

Medical Device Regulation: Step 1

Step 1 - Determine whether your product is classified as a medical device.

The starting point is determining whether the product you plan to market is a medical device, as defined in section 201(h), or a radiation-emitting product, as defined in section 531 of the FD&C Act, or both. If your product meets either of these definitions, it will be subject to the provisions of the FD&C Act, that is, there are FDA regulatory requirements that must be met before a product can be marketed in the U.S. The purpose of Device Advice is to help you decide whether your product is subject to FDA regulations, and if so, to identify what these regulatory requirements are and help you comply with them.

Regulatory Requirements

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

FDA Guidance Documents

Guidance documents are documents prepared for FDA staff, regulated industry, and the public that describe the agency's interpretation of or policy on a regulatory issue. Guidance documents include, but are not limited to, documents that relate to:

  • the design, production, labeling, promotion, manufacturing, and testing of regulated products
  • the processing, content, and evaluation or approval of submissions
  • inspection and enforcement policies

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.

Find Federal Regulations

Other Important Databases