Description
FDA developedthis documentto provide guidance to industry and FDA staff about the regulation of accessories to medical devices. This guidance is intended to describe FDA’s policy concerning the classification of accessories and to discuss the application of this policy to devices that are commonly used as accessories to other medical devices. In addition, this guidance explains what devices FDA generally considers an “accessory” and describes the processes under Section 513(f)(6) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow requests for risk- and regulatory control-based classification of accessories.
Scope & Applicability
Product Classes
4The primary device that an accessory is intended to support
Generally recommended for Enhanced Documentation; Regulatory classification mentioned for implantable sensors and HPV tests; Mentioned in the context of an in vitro nucleic acid test for CMV DNA.
Low risk medical devices
Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders
Stakeholders
3Entity responsible for submitting applications under section 524B
Entity responsible for submitting NDINs
Manufacturers or other parties who submit a Q-Sub or marketing submission.; The entity responsible for the Q-Sub and drafting meeting minutes.
Regulatory Context
Attributes
3Specifications that are directly associated with the intended use of the device.
Technical characteristics ensuring the accessory works with parent devices
design features that must remain the same for protocol reuse
Identified Hazards
Hazards
1Probable risks associated with the use of the device.
Related CFR Sections (1)
- 21CFR820.3§ 820.3 Definitions.
The definitions in ISO 13485 and in Clause 3 of ISO 9000 (incorporated by reference, see § 820.7 ) apply to this part, except as specified in paragraph (b) of this section, and do not affect the meaning of similar terms defined in this title.Read full regulation →
See Also (8)
- Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic Product: Guidance for Industry (Status: Final)
- Remanufacturing of Medical Devices: Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff (Status: Final)
- 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes: Guidance for Industry and FDA Staff (Status: Final)
- Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19): Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff (Status: Final)
- Medical Device Classification Product Codes - Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)