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Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception

FinalCenter for Biologics Evaluation and Research11/16/2017
Homologous UseMinimal ManipulationEstablishment Registration and Listing

Description

We, the Center for Biologics Evaluation and Research (CBER)1 at the FDA, are issuing this guidance to provide you, tissue establishments and healthcare professionals, with our current thinking on the scope of the exception set forth in Title 21 of the Code of Federal Regulations (CFR) Part 1271, specifically the exception set forth in 21 CFR 1271.15(b). This guidance does not address the other exceptions in 21 CFR 1271.15.  This guidance, presented in question and answer format, provides our current interpretation of this regulation and includes examples based on inquiries received by the Agency since the final rule, “Human Cells, Tissues, and Cellular and Tissue Based Products; Establishment Registration and Listing” (Establishment Registration and Listing final rule) was published on January 19, 2001 (66 FR 5447).

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

2
HCT/P

Human cells, tissues, and cellular and tissue-based products regulated as devices; Human cells, tissues, and cellular and tissue-based products regulated as medical devices; Human Cell, Tissue or Cellular or Tissue-Based Product

HCT/Ps

Human cells, tissues, or cellular or tissue-based products defined in 21 CFR Part 1271

Stakeholders

3
Establishment

Entities making donor eligibility determinations

healthcare professionals

Use of local healthcare professionals (HCPs) and facilities.

tissue establishments

Entities involved in the removal or processing of HCT/Ps.

Regulatory Context

Regulatory Activities

1
Registration

Requirement for facilities to register under section 415 of the FD&C Act

Technical Details

Substances

1
Adipose tissue

extracted from a horse for MSC isolation; Example of recovered tissue

Testing Methods

1
Centrifugation

Extraction of honey from a honeycomb may be facilitated by centrifugation

Processes

4
Enzymatic digestion

Processing of adipose tissue to isolate cellular components

Manufacture

The process for which all components must be listed

Implantation

Process for which local effects and biocompatibility are evaluated

Processing

Activity that triggers the requirement for facility registration.

Clinical Concepts

2
Parathyroidectomy

Surgical removal of parathyroid tissue

Craniotomy

Surgical procedure involving removal of bone flap

Identified Hazards

Hazards

3
Cross-contamination

Risk associated with construction, traffic flow, and shared equipment.; Risk from raw food to RTE food or from insanitary objects; Personnel handling RTE foods touch contaminated surfaces

Contamination

Microorganisms or particulate matter that could adversely affect the device.

communicable diseases

risks associated with HCT/P donation

View on FDA.govDownload PDF

Related CFR Sections (3)

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Unapproved new drugs
10
Misbranded drug
6
Unapproved new drug
6
Failure to validate aseptic processes
5
Unlicensed biological products
5
Failure to establish and follow appropriate written procedures designed to prevent microbiological contamination
4
Failure to establish and maintain procedures for donor eligibility
4
Failure to validate and approve a process
3
Failure to determine and document the eligibility of a cell or tissue donor
3
Failure to test a specimen from an anonymous or directed reproductive donor for evidence of infection
3

Recent Cases

Related Warning Letters (10)

Related MFDS Guidelines

Korean regulatory guidelines covering similar topics

See Also (8)