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

 

Previous Chapter  Next Chapter


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

8https://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.