Updated March 30, 2020
The past few weeks have brought disruption to our daily lives in ways large and small.  May we learn what is important and where to spend our energy from this experience.  The FDA is also undergoing extreme disruption as they work to continue to protect the public health and respond to the global COVID-19 pandemic.  We and companies like ours are experiencing a huge increase in calls from companies interested in understanding FDA requirements in order to respond to this emergency. We are always eager to educate, inform, and serve you and hope that you will find this article helpful.  I will list a few basic concepts and then provide links to specific FDA programs enacted in response to COVID-19. Be sure to contact us with any questions.

  1. While some requirements have been reported as ‘loosened’ and some FDA activities characterized as ‘dropped’ in consumer and trade publications, the basic premise that products intended for use in and on the human body must be safe and effective remains in effect.
  2. FDA has issued Emergency Use Authorizations to increase the supply of products required for health care personnel and first responders but a strong regulatory framework is still in place for those products.

Applicable to a variety of products
 Update: Adverse Event Reporting
FDA has issued published guidance on Adverse Event (AE) reporting for medical products and dietary supplements during the COVID-19 pandemic. While normal AE reporting should be maintained whenever possible, the agency notes that workforces may be reduced during a pandemic; therefore, this guidance is intended for firms unable to continue normal reporting operations, where impacted firms are requested to focus reporting on AEs related to medical products indicated for the treatment or prevention of the pathogen causing the pandemic (not limited to influenza or COVID-19), and other reports indicated in the guidance document or specified by FDA. It should be noted this guidance does not extend to monitoring or reporting AEs for investigational use of drugs, biologics, and devices or guidance imposed as a condition for medical products authorized for emergency use.
A number of pandemic preparedness planning resources are available to firms, which can be found here and here. Companies should develop a continuity of operations plan (COOP) that includes instructions for AE reporting and the submission of AE reports at a future time. Should a company be unable to fulfill normal AE reporting activities, documentation should include a formal declaration of the pandemic by a respected regulatory or governing body (i.e., the World Health Organization) and specific factors preventing normal AE reporting requirements (i.e., high absenteeism).
FDA notes that any delayed AE reports should be submitted within 6 months of the restoration of AE reporting activities to the pre-pandemic state. For impacted firms, AE reports should be submitted on a priority basis, where reports with regulatory timeframes of < 30 days should be submitted before periodic safety reports. If FDA has designated a product as presenting special concerns, AE reports must be submitted regardless of the timeframe. For medical devices, the agency notes that priority is specified by the outcome, where a fatal outcome is prioritized over a nonfatal outcome. Further guidance on AE report prioritization is provided in Table 1 of the guidance.
Industry Specific News:
Medical Devices
You have heard that new diagnostic tests are undergoing expedited reviews and being approved almost daily. These devices are the subject of the most far-reaching Emergency Use Authorization (EUA) FDA has issued in response to COVID-19. See also FAQs on diagnostic tests and the section titled, “In Vitro Diagnostics EUAs” on this page.
Personal Protective Equipment (PPE) including N95 masks, surgical masks, gloves, face shields, and gowns are medical devices.  The only change to the regulatory requirements for these products is that FDA has allowed for the use of expired N95 masks.  See details here, here, here, and in a ‘down arrow’ section under Personal Protective Equipment EUA on this page.
FDA has also provided a set of FAQs on gloves with a section specifically for companies that want to start supplying gloves.
All other regulations for GMPs, quality systems, device registration, and 510(k) submissions still apply.
Update:  Ventilators and Other Respiratory Devices
FDA has published guidance on an enforcement policy to expand the availability of Class II ventilators, anesthesia gas machines, and other respiratory devices and their accessories during the COVID-19 pandemic. The agency’s policy provides flexibility for manufacturers to modify devices to reduce manufacturing limitations or prevent supply shortages.  This flexibility does not reduce FDA’s requirements for validation of the safety and efficacy of the ventilators produced under this temporary emergency policy.
While the use of “FDA-cleared conventional/standard full-featured ventilators” is preferred, the agency notes that modification to the indications, claims, functionality, hardware, software, or materials of a device may be required which would ordinarily require a premarket notification submission. Specific examples are outlined in the guidance document. Furthermore, FDA has noted that specific durations of use or shelf life may be extended for various ancillary devices in situations that would not create undue risk.
The agency notes that manufacturers should conduct and document appropriate validation for changes made to hardware, software, materials, or duration of use as outlined in the guidance document. All changes should be recorded in the device master record and change control record. Devices that have been modified should be labeled with: a description of the device’s indications, claims, or functions, and performance and potential risks; instructions for use, environment of use, and details on the design differences and known risks; and delineation of FDA-cleared indications and claims from those which have not been cleared by FDA.  The agency requests that manufacturers work with FDA through its EUA process.
Drugs Including Hand Sanitizers and Therapeutics
Hand sanitizers are regulated as over-the-counter drugs.  The ingredients used in them have been under FDA review for years and the agency has divided the category into products for health care professionals and consumers.  Due to the current need for products in both categories, FDA has temporarily reversed previous decisions and has issued emergency use authorizations for hand sanitizers. These policies allow for companies that do not typically manufacture drugs to make hand sanitizers.  This is a temporary authorization and requires companies making hand sanitizer to follow basic good manufacturing procedures, register their facilities (for inspection purposes), and list these products with FDA.  Please see the policy here.  There is a separate but similar policy for compounding pharmacies.
FDA has published a webpage to help companies with potential COVID-19 therapeutics.  Changes to FDA’s foreign and domestic inspection program are discussed here.
Update:  Alcohol-Based Hand Sanitizer Products
On March 27, 2020, FDA updated a temporary policy regarding the manufacture of ethyl alcohol for incorporation into alcohol-based hand sanitizers. As production of alcohol-based hand sanitizers ramps up, the demand for raw materials, including ethanol, has increased. FDA’s policy allows for manufacturers to produce ethanol (also referred to as ethyl alcohol) for use as the Active Pharmaceutical Ingredient (API) in alcohol-based hand sanitizers for consumer and health care professional use during the COVID-19 public health emergency, as long as: the companies produce ethanol of sufficient purity (as outlined in the guidance document) following basic good manufacturing procedures; denature and label the ethanol following appropriate methods detailed in the guidance document; register their facilities; and list these products with FDA.
Denaturing the ethanol is a critical step to prevent adverse events from unintentional ingestion of hand sanitizer. The ethanol can be denatured by the manufacturer or at the point of manufacture or compounding of the hand sanitizer. While FDA continues to evaluate appropriate denaturing formulas, the agency provides formulas in Appendix C of the guidance document for the use of denatonium benzoate with or without tert-butyl alcohol, sucrose octaacetate with or without tert-butyl alcohol, or isopropyl alcohol as denaturants.
Update:  Drugs Subject to a Risk Evaluation and Mitigation Strategy
A limited number of drugs are subject to a Risk Evaluation and Mitigation Strategy (REMS), which may include a Medication guide, patient package insert, communication plan, and/or certain packaging or safe disposal technologies for drugs. Elements to assure safe use (ETASU) may also be part of the REMS requirements for a drug, which can require laboratory testing or imagining studies. Given that patients may be unwilling or unable to complete the required testing or studies due to self-isolation or quarantine, FDA has published a policy regarding REMS requirements during the COVID-19 pandemic.
The agency states that health care providers prescribing and/or dispensing REMs drugs should consider whether or not compelling reasons exist to not complete the test or studies, and to use their best medical judgment to weight the benefits and risks of completing treatment in the absence of laboratory tests and imaging studies. Health care providers should communicate these considerations to patients. While the REMS requirements remain in effect, FDA does not intend to take action for failure to adhere to certain laboratory testing or image study requirements.
Foods, Dietary Supplements, and Animal Foods
On March 18, 2020, FDA held a briefing for the food industry, including the dietary supplement and animal food industries.  While COVID-19 is not a food-borne illness, FDA discussed the importance of good sanitation and maintenance of standard GMPs in manufacturing activities, which always includes the need to ensure that employees are healthy.  FDA has published a set of FAQs for the food industry.
The agency also discussed changes to their inspection activities. They have postponed routine foreign and domestic facility inspections.  “For cause” domestic inspections will still take place and “mission critical” foreign inspections “will be considered on a case-by-case basis.”
During the March 18 briefing, FDA announced that domestic supplier verification required under the Food Safety Modernization Act (FSMA) and Foreign Supplier Verification Program (FSVP) requirements would not be enforced as a temporary measure.  Food, dietary supplement, and animal food companies must still be diligent to ensure the safety of their products.
Update:  Nutrition Labeling    On March 26, 2020, FDA published guidance regarding a temporary policy for nutrition labeling requirements of specific packaged food during the COVID-19 pandemic. The guidance is intended to provide flexibility in label requirements to restaurants and restaurant-supply food manufactures to enable them to sell specific packaged foods directly to retail consumers. It does not apply to restaurant prepared foods.
The agency has indicated that restaurants and food manufacturing facilities with inventory labeled for restaurant use may sell packaged foods without a Nutrition Facts label as long as the food does not have any nutrition claims and is labeled with: a statement of identity; ingredient statement; the name and place of business of the food manufacturer, packer, or distributor; net quantity of the contents; and allergen information required by the Food Allergen Labeling and Consumer Protection Act (FALCPA). Original packaging labels may be reused or labels may be created to provide the necessary information to the consumer.
Cosmetics
There have been no new policies issued for cosmetic manufacturers due to COVID-19.  The changes to inspection activities discussed above apply to cosmetic companies.
Our team is fortunate to remain healthy and at work, so let us know if you have questions on these or other FDA compliance topics.  Meanwhile stay calm, stay well, and stay put.
30 March 2020 Thanks to Katrina Emmel for assistance with this update.