Medical Device Shelf Life & Accelerated Aging Toolkit: ASTM F1980 Templates
Medical Device Shelf Life Toolkit — accelerated aging protocol (ASTM F1980), real-time aging plan, shelf life rationale, package integrity testing plan, aging study report, and shelf life labeling guidance.
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Frequently Asked Questions
Can accelerated aging replace real-time aging for 510k submissions?
FDA accepts accelerated aging data at time of 510k submission provided a parallel real-time aging study is ongoing and the accelerated protocol follows ASTM F1980. Both protocols are included.
What Q10 factor should I use?
ASTM F1980 uses a Q10 of 2.0 as the default. Some materials justify values of 1.8-3.5 with appropriate rationale. The shelf life rationale document template covers Q10 selection and documentation.
What file format are the templates in?
All templates are provided in editable Microsoft Word (.docx) format. You can customize them to match your companyx27s branding and specific requirements.
How quickly will I receive the files?
Instantly. After purchase, youx27ll receive an email with download links within 2-3 minutes. Check your spam folder if you donx27t see it.
Can I use these for multiple projects or clients?
Yes. Your purchase includes a company-wide license. Use the templates across all your projects and devices within your organization.
Do these templates get updated when regulations change?
Yes. Youx27ll receive free updates via email whenever we update templates for new guidance or regulatory changes.
What if I need help customizing the templates?
Email us at support@regwatchdaily.com. We typically respond within 24 hours with guidance on customization.
Is there a money-back guarantee?
Yes — the Audit-Ready Guarantee. If youx27re not satisfied within 7 days, email us for a full refund. No questions asked.