510(k) third party review program: guidance for industry, Food and Drug Administration staff, and third party review organizations
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Devices and Radiological Health (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, March 12, 2020
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Device Approval United States United States. Department of Health and Human Services. United States. Food and Drug Administration.
- Genre(s):
- Technical Report
- Abstract:
- The 510(k) Third Party (3P510k) Review Program (formally known as the Accredited Persons (AP) Program) is authorized under section 523 of the Federal Food, Drug, and Cosmetic (FD&C) Act. Under this authority, FDA recognizes third parties to review premarket notification (510(k)) submissions and recommend the initial classification of certain devices. FDA's implementation of section 523 establishes a process for recognition of qualified third parties to conduct the initial review of 510(k) submissions for certain low-to-moderate risk devices eligible for review under the 3P510k Review Program within the Center for Devices and Radiological Health (CDRH). This guidance document also reflects amendments made to section 523 by the FDA Reauthorization Act of 2017 (FDARA), which directed FDA to issue guidance on the factors that will be used in determining whether a class I or class II device type, or subset of such device types, is eligible for review by an accredited person. For the current edition of the FDA-recognized standards referenced in this document, see the FDA Recognized Consensus Standards Database. For more information regarding use of consensus standards in regulatory submissions, please refer to FDA guidance entitled, "Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices". The objectives of this guidance are: (1) To describe the factors FDA will use in determining device type eligibility for review by 3P510k Review Organizations. (2) To outline FDA's process for the recognition, rerecognition, suspension, and withdrawal of recognition for 3P510k Review Organizations. (3) To ensure consistent quality of work among 3P510k Review Organizations through the Medical Device User Fee Amendments (MDUFA) IV commitments authorized under FDARA7to eliminate the need for routine, substantive re-review by FDA.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (38 pages))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 101772638 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/101772638