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FDA’s New Draft Rule: “Medical Devices; Quality System Regulation Amendments

On February 22, 2022, FDA published a proposed rule that aims to harmonize the current Quality System Regulation for Medical Devices under 21 CFR part 820 with international standards, ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes. If finalized, the new regulation will be called the Quality Management System Regulation.

The public comment period is open for 90 days and comments may be submitted at regulations.gov/. Additionally, on March 2, 2022 a public advisory committee meeting of the Device Good Manufacturing Practice Advisory Committee is being held to discuss the proposed changes. Follow the hyperlinks above to provide comments on the proposed rule and to register for the public advisory committee meeting.

As of February 15, 2022, the U.S. Senate has confirmed Dr. Robert Califf by a vote of 50 to 46 to be the next FDA Commissioner.  Dr. Janet Woodcock will remain on in the position of Principal Deputy Commissioner to continue to oversee several of the important FDA initiatives she has been engaged with while serving as Acting Commissioner.

In an email sent by FDA on Monday 14 February 2022, the FDA pointed out that the Draft Guidance issued in October 2021 is not a binding document, and the reporting date is not a requirement. The 15 February 2022 CARES Act Reporting Date for 2020 Amounts of Listed Drugs and Biological Products is a recommendation.

Announced in the FDA Roundup of Feb 4, 2022 the FDA determined that beginning Feb. 7th, the agency will resume conducting domestic surveillance inspections across all commodities given the decline in COVID-19 cases across the country. This is an update to the temporary changes the FDA had announced in late Dec. 2021 in an effort to keep FDA and industry staff safe during the evolving COVID-19 pandemic and the spread of the omicron variant.

The ongoing inspections of both foreign and domestic mission-critical facilities will continue as they have been, with FDA leveraging a variety of tools, including remote assessments.

As already announced, previously planned foreign surveillance inspections that have received country clearance and are within the Center for Disease Control and Prevention’s Level 1 or Level 2 COVID-19 travel recommendation will proceed. The agency is working toward conducting foreign prioritized inspections beginning in April 2022.

Guidance Documents of Interest

Good ANDA Submission Practices Guidance for Industry

This guidance highlights common, recurring deficiencies that may lead to a delay in the approval of an ANDA. It also makes recommendations to applicants on how to avoid these deficiencies with the goal of minimizing the number of review cycles necessary for approval.

Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments

This guidance explains how FDA will issue and use an information request and/or a discipline review letter during the assessment of an original abbreviated new drug application. This guidance does not apply to an amendment made in response to a complete response letter, a supplement, or an amendment to a supplement.

Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry

This guidance provides recommendations on identifying RLD labeling updates and submitting ANDA amendments or supplements to update generic drug labeling.

Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs

This guidance specifies the procedures and principles for formal meetings between FDA and sponsors or requestors for an OTC monograph drug. It describes procedures under which meeting requesters can meet with appropriate FDA officials to obtain advice on the studies and other information necessary to support submissions under section 505G of the FD&C Act, to obtain advice on other matters relevant to the regulation of nonprescription drugs, and to obtain advice on the development of new OTC monograph drugs.

Principles of Premarket Pathways for Combination Products

This guidance presents the current thinking of FDA on principles for premarket review of combination products. This guidance offers general, high-level information regarding what combination products are, coordination within FDA and interaction between FDA and sponsors regarding combination product regulation, and how combination products are reviewed by FDA before they are marketed.

Drug Product Tracing: The Effect of Section 585 of the FD&C Act instead of FDA’s guidance on uniform national policy

Section 585 requires there be a uniform national policy, preempting States from establishing or continuing in effect certain standards and requirements. FDA is issuing this guidance to: (1) help industry and States understand the law as it is currently in effect; and (2) clarify the effect of section 585(a) on any regulation of drug product tracing by States.

All Guidance Documents can be searched on the FDA’s website.

FDA Websites of Interest

Product-Specific Guidances for Generic Drug Development

  • 30 new and 13 revised PSGs
  • 13 PSGs for complex products (11 new and 2 revised); 11 of these for products with no approved ANDAs (10 new and 1 revised)
  • 34 PSGs for products with no approved ANDAs (23 non-complex and 11 complex products)

Tracking Your Premarket Submission’s Progress (Progress Tracker)

FDA announces proposed rule: National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers

Bulk Drug Substances Used in Compounding Under Section 503B of the FD&C Act.

Four bulk drug substances have been added to the list in February.


OTC Monograph Reform: Overview of Draft Guidance for Formal Meetings

Date: 29 March 2022
Time: 2:00 PM – 3:00 PM EDT

FY 2022 Generic Drug Science and Research Initiatives Public Workshop

Dates: 9-10 May 2022
Day1: Mon, 9 May – 8:00 AM – 4:30 PM EDT
Day2: Tue, 10 May – 8:00 AM – 5:00 PM EDT

46th International Good Manufacturing Practices Conference

Dates: 7-10 March, 2022
See the website for further details.

FDA-EMA Parallel Scientific Advice (PSA) Program

Date: 16 March 2022
Time:  10:00 AM – 11:30 AM EDT

Posted in Drug and Device Corner, Drugs, Medical Devices.