Information on PPE Product Specifications for Manufacturing

Dear IFAI Members and Industry Contacts, In the rapidly evolving regulatory environment involving COVID-19 procurement of Personal Protective Equipment (PPE), we wanted to provide you with the latest guidance we have received from the White House and FDA. Product specifications: We have received a lot of member requests for certain product...

Dear IFAI Members and Industry Contacts,

In the rapidly evolving regulatory environment involving COVID-19 procurement of Personal Protective Equipment (PPE), we wanted to provide you with the latest guidance we have received from the White House and FDA.

  1. Product specifications: We have received a lot of member requests for certain product specifications for medically related textiles. You can search here on the CDC website by product name (gowns, caps, etc.), and it will bring up the current NIOSH-approved specs.
  2. Procurement: FEMA’s National Response Coordination Center (NRCC) is facilitating procurement. Contract proposals should be sent to FEMA-NRCC-rssc@fema.dhs.gov. The White House has advised the more granularity the better for specific proposals but at the very least it should include the information provided in the attached document. In addition to submitting your proposal to FEMA, you should also cc Janelle Buerkley (jwbuerkley@ifai.com).
  3. FDA Waivers: A template to file for FDA waivers for needed PPE is provided below. Before reviewing, however, note that you DO NOT need to file for a waiver for Level 1 and 2 gowns and non-medical facemasks. To facilitate a rapid response on other items, the following information should be emailed to the FDA to request a waiver:

Template for Contacting FDA for Waivers:

Manufacturers may email FDA at deviceshortages@fda.hhs.gov for items that are non-medical masks and gowns (i.e. – the item guidance above) requesting waivers. We understand that this website is closely being monitored. We suggest that you also cc Janelle Buerkley (jwbuerkley@ifai.com) on any waiver requests you submit to the FDA at the email address above so we are aware of this request.

Subject of the email: “Product Codes XXX, Shortage Mitigation Options for FDA Engagement,” where XXX represents the product code(s).

Body of the email:

  • Describe the affected product or products which may include the brand name, model number, 510(k) number, etc.
  • Describe the proposed mitigation approach.
  • Identify what you are interested in discussing with FDA, such as:
    • Expedited review of a premarket submission, or
    • Expedited review of a manufacturing site change if you are a class III device manufacturer, or
    • Information about importing certain products.

In addition to this template for PPE waiver requests in general, we received some specific guidance from the White House and Congressman McHenry’s (R-NC) office last night on gowns and non-medical face masks. While the FDA is expected to issue more formal and overarching waiver guidance on PPE standards, we are being asked to share the information below with companies because of the severe shortage of masks and gowns. Additional general information can be found on the FDA’s PPE webpage here.

Gowns:

Surgical gowns (including surgical isolation gowns), surgical hoods and surgical togas are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, bodily fluids, and particulate material. FDA regulates surgical gowns, surgical isolation gowns, surgical hoods and surgical togas as Class II devices and assesses them for liquid barrier protection among other things.

FDA does not object to your marketing and distribution of the gown and surgical apparel products in the healthcare setting without prior 510(k) clearance if the product is labeled in the following manner:

  1. The apparel is not labeled as “surgical”; rather it may be labeled as a “gown”, “toga”, “hood”, etc.
  2. It states it may be used when FDA cleared gowns or apparel are unavailable
  3. Includes a recommendation against use in a surgical setting or where significant exposure to liquid bodily or other hazardous fluids may be expected;
  4. Includes a recommendation against use in a clinical setting where the infection risk level is high;
  5. It makes no claims regarding flammability;
  6. It makes no claims of antimicrobial or antiviral protection;
  7. It makes no claims of infection prevention or reduction;
  8. Contains a list of the body contacting materials.

In addition, FDA does not intend to object to marketing of gowns and other surgical apparel that meet the above criteria even if they are manufactured at facilities that do not meet 21 CFR 820.

Masks:

Surgical masks provide protection against large droplets, splashes or sprays of bodily or hazardous fluids. They do not provide the wearer with reliable protection from inhaling smaller airborne particles and are not considered respiratory protection. FDA regulates surgical masks as Class II devices and assesses them for liquid barrier protection among other things.

FDA recognizes the urgent need for face masks in the setting of the COVID-19 pandemic due to increased use and shortages in their availability.

FDA does not object to the marketing and distribution of face masks in the healthcare setting without prior 510(k) clearance if the product is labeled in the following manner:

  1. It states it may be used when FDA cleared masks are unavailable;
  2. It recommends against use in a surgical setting or where significant exposure to liquid bodily or other hazardous fluids may be expected;
  3. It makes no claims of antimicrobial or antiviral protection;
  4. It makes no claims of infection prevention or reduction;
  5. It makes no claims regarding flammability
  6. The labeling contains a list of the body contacting materials.
  7. The mask is not labeled as a “surgical mask”; rather it may be labeled as a “face mask”

In addition, FDA does not intend to object to marketing of masks that meet the above criteria even if they are manufactured at facilities that do not meet 21 CFR 820.

As noted above, this is an incredibly fluid situation. We will send any official or additional guidance we receive from the White House, FDA, FEMA and other relevant agencies as soon as we receive such information.

Source: www.ifai.com