Medical Equipment and PPE Regulatory Reference Guide
The COVID-19 pandemic has had an unprecedented impact on the world. As healthcare providers work on the front line to combat the pandemic, the supply of ventilators, face masks and other personal protective equipment (PPE) are growing scarce. As manufacturers, many of you are in the process of supporting these ongoing needs.
To assist you in the fight, we’ve put together this guide to share the proper protocols for U.S. regulatory submission, as provided by the FDA, CDC and ASTM, to help ensure your products get to market as quickly as possible and into the hands of our healthcare providers.
Free resources to support COVID-19
- Relevant ASTM Testing Standards & Specifications
- Relevant ISO Testing Standards & Specifications
- Relevant IEC Standards & Specifications
- Recent Final Medical Device Guidance Documents
- FDA Emergency Use Authorizations
Guidance for Medical Gloves and Gowns
- Enforcement Policy for Gowns, Gloves, etc.
- FAQs of Shortages of Surgical Masks and Gowns
- Questions about Personal Protective Equipment (PPE)
FDA Industry Guidance for Face Masks & Respirators
- Enforcement Policy for Face Masks and Respirators
- N95 Respirators and Surgical Masks (Face Masks)
- MOU using 3D printing between NIH, FDA, and VHA
FDA Industry Guidance for Ventilators
- Enforcement Policy for Ventilators
- Ventilator Supply Mitigation Strategies
- FDA Ventilator and EUA Guidance
U.S. Customs and Border Protection
Reminder: Format the correspondence in accordance with the relevant FDA guidance document to expedite response.
For additional FDA contact information, please call: 1-888-INFO-FDA
For questions regarding the appropriate product coding, or if requesting energy use authorizations for diagnostic devices, or if requesting energy use authorizations for non-diagnostic devices, please email the FDA directly.
For questions about how we can help with testing services, please contact us.
Personal Protective Equipment (PPE) Testing
Element has developed solutions to perform and/or coordinate the required testing for PPE, hand sanitizers, masks, gowns, and face shields to help you get these products to market.
Medical Product Testing
With a clear understanding of your markets, regulations, and challenges, we provide our expertise and experience with cGMP, GLP, ISO/IEC 17025 testing to help your product reach the market sooner and with safety and quality built in.
Chemical Compatibility Testing for Medical Devices, Materials, and Surfaces
Element can offer automated chemical compatibility testing that gives faster and more reliable results for medical device compatibility with medical disinfectants.
CV19 Secure - Workplace Assurance
Element provides independent audits for UK businesses’ COVID-19 workplace risk assessments. This scheme will audit your workplace risk assessment, identify any gaps and areas for improvement.