Overview of regulatory and approving agencies for medical devices and considerations for manufacturers

Regulatory Agencies

The FDA, NIOSH, and OSHA are the primary agencies involved in the certification, approval, and enforcement of PPE regulations.

Agency	Mission	Role Relative to PPE
Food and Drug Administration (FDA)	Protect public health by ensuring the safety, efficacy, and security of foods and drugs, including medical devices	Sets the regulations and specific performance standards for the majority of PPE
National Institute for Occupational Safety and Health (NIOSH)	Develop new knowledge in the field of occupational safety and health	The CDC agency responsible for the certification and approval of respiratory devices for occupational use
Occupation Safety and Health Administration (OSHA)	Assure safe and healthy working conditions by setting and enforcing standards	Sets and enforces standards and provides training to ensure safe and healthful working conditions for employees that may require the use of PPE

FDA Categorization

The FDA categorizes medical devices across three regulatory classes based on the level of control necessary to assure device effectiveness. Following is a list of regulatory requirements,¹ in order from less to more in general level of FDA regulation, and the PPE items for each class.²

Class I: Exempt from 510(k) marketing approval and design controls

Non surgical gowns
Exam gloves³
Scrubs and coveralls
Head and shoe covers

Class II: 510(k) required if marketing a device for the first time

Surgical gloves
Patient/isolation masks
Surgical gowns
Surgical N95 respirators

Class III: Pre-market approval (PMA) the most stringent regulatory category for medical devices

None

FDA COVID-19 Requirements

FDA requirements are significantly different during the COVID-19 pandemic compared to “normal” conditions.

FDA Requirements⁴	During normal conditions	High-priority Class I/II PPE as of April 2020⁵
FDA pre-market notification 510(k)	Depends⁶	No
Registration and listing	Yes	No
Quality System Regulation	Yes	No
Reports or corrections/removals	Yes	No
Unique Device Identification	Yes	No
Labeling accurately describing intended use	Yes	Yes

CDC Guidance on Gowns

CDC guidance states that Level 1 isolation gowns are appropriate PPE for routine COVID-19 patient care.⁷

Healthcare professionals (HCPs) can use non-surgical isolation gowns when performing routine care for COVID 19 patients.⁸

Non-surgical gowns

If gowns are running low, FDA⁸ indicates that HCPs can extend the use of disposable gowns without changing between Covid 19 patients. If the gown becomes contaminated, it should be changed.
Reusable gowns (those specifically constructed to be cleaned) should be washed after each patient is treated; can also spray gowns after use with decontamination fluid (ethanol based spray)⁸

Surgical gowns should only be used in scenarios where healthcare professionals will be at
moderate to high risk of exposure to fluid.⁸

Non-surgical Isolation Gowns

ANSI / AAMI Standard Barrier Protection	Level 1: Minimal Risk (Minimum requirement for COVID)	Level 2: Low Risk
Standard Use	Basic care, standard isolation, standard medical unit	Blood draw, suturing, ICU, or pathology lab
COVID-19 Applicability	Routine potential and current COVID patient care	Routine potential and current COVID patient care

Surgical Gowns and Surgical Isolation Gowns

ANSI / AAMI Standard Barrier Protection	Level 3: Moderate Risk	Level 4: High Risk
Standard Use	Arterial blood draw, inserting an IV, in the ER, or for trauma cases	Surgery, fluid intense procedures, surgery, infectious diseases suspected
COVID-19 Applicability	Environments that will expose wearer to fluid (e.g., intubations, vomiting patient, etc.)	Surgical purposes and environments that will expose wearer to fluid

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1. https://www.fda.gov/medical-devices/consumers-medical-devices/learn-if-medical-device-has-been-cleared-fda-marketing

2. CDC PPE COVID-19 guidance (23 Mar 2020)

3. Class I (reserved) subject to premarket notification marketing 510(k) requirements

For the most updated information, visit the FDA’s COVID-19 page: https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19

4. Electronic Code of Federal Regulations, Title 21, Subchapter H – Medical devices

5. FDA COVID-19 Public Health Emergency Enforcement Policies for (a) Face Masks and Respirators and (b) Gowns, Other Apparel, and Gloves

6. Class I – 510(k) exempt Medical devices do not require a pre market notification under normal conditions

7. https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirator-use-faq.html

8. https://www.fda.gov/medical-devices/letters-health-care-providers/surgical-mask-and-gown-conservation-strategies-letter-health-care-providers

WORKING DOCUMENT, SUBJECT TO CHANGE. NOT EXHAUSTIVE.

DOCUMENT INTENDED TO PROVIDE INSIGHT BASED ON CURRENTLY AVAILABLE INFORMATION FOR CONSIDERATION AND NOT SPECIFIC ADVICE.

COVID-19 PPE Manufacturer Resources Available (as of April)

FDA Regulation

The FDA has made exceptions under Emergency Use Authorizations (EUA) to minimize regulatory hurdles to production
The FDA regulates devices based on claims made by the manufacturer (e.g., regulated if infection prevention is claimed)
PPE products marketed to the public for general, non medical purposes will not require FDA marketing authorization (510(k)); they must be labeled accordingly

Message for Manufacturers

The FDA does not intend to object to the distribution of certain items during the public health emergency IF they do not create “such an undue risk”
This risk can be mitigated through:
- Appropriate labeling⁵
- Demonstrated ability to meet applicable manufacturing and design requirements⁵
Given frequent policy changes, manufacturers should visit the FDA’s COVID-19 website