Description
In the Federal Register of July 8, 1997 (62 FR 36558), the Food and Drug Administration announced the availability of Revised Form FDA 356h Application to Market a New Drug, Biologic, or an Antibiotic for Human Use This document provides guidance on the content and format of information to be submitted to the Chemistry, Manufacturing, and Controls (CMC) section and Establishment Description section of a License Application for a biological in vitro diagnostic (IVD) product.
Scope & Applicability
Product Classes
2CMC information for IVD products; Specific product class mentioned in guidance references
IVDs requiring UDI on labels
Stakeholders
3Entity responsible for submitting NDINs
Entities responsible for manufacture and labeling of CSP; Must follow instructions for use provided by the device manufacturer; Blood establishments that manufacture licensed blood components
Assess the suitability and competence of potential contractors before outsourcing operations
Regulatory Context
Attributes
4Measurement of potency for biological products
Determined by the sponsor for the investigational product.; investigational product(s) are stable over the period of use and only used within the current shelf life
specifications for the purity, strength, and composition of dietary supplements
Measured during operations in manufacturing areas
Identified Hazards
Hazards
5Microorganisms or particulate matter that could adversely affect the device.
Validation for inactivating or removing pathogens
Potential for contamination of covered produce; Known or reasonably foreseeable hazards in water
Facilities designed to prevent cross-contamination
Potential contaminant from animal source materials
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 →
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See Also (8)
- Medical Device Accessories - Describing Accessories and Classification Pathways: Guidance for Industry and FDA Staff (Status: Final)
- Remanufacturing of Medical Devices: Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff (Status: Final)
- Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 130.400 Use of Microfiche and/or Microfilm for Method of Records Retention (Status: Final)
- CPG Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections (Status: Final)
- CPG Sec. 300.100 Inspection of Manufacturers of Device Components (Status: Final)
- Device Labeling Guidance #G91-1 (Blue Book Memo) (Status: Final)
- CPG Sec. 310.100 Pacemaker Reuse (Status: Final)