The International Medical Device Regulators Forum (IMDRF) has released a proposal that will guide devicemakers on producing a comprehensive Table of Contents for premarket IVD applications.
The guideline lists several elements manufacturers should include in their submissions, noting that common elements between IMDRF members as well as country-specific regulations or content need to be included.
The guideline’s hierarchy is as follows:
- Regional administrative;
- Submission context;
- Nonclinical evidence;
- Clinical evidence;
- Labeling and promotional materials;
- Quality management system procedures; and
- Quality Management System Device Specific Information.
The guidance notes regional regulatory guidance will vary between IMDRF members. When any conflicting requirements arise between this and regional documents, regional laws will take precedence, the guidance notes.
Comments on the guidance are due Jan. 17, 2014. View the proposal at www.fdanews.com/ext/resources/files/12/12-04-13-IMDRF.pdf. — Nick Otto
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