Upcoming FDA Rulemakings: Device Quality Systems, Post Approval Changes to NDAs and BLAs and More

Regulatory NewsRegulatory News | 09 May 2018 |  By 

The Department of Health and Human Services (HHS) on Wednesday released the spring version of its unified agenda on proposed and final rulemakings, featuring a proposed rule on quality system regulations for medical devices and the de novo qualification process, and a final rule on postmarketing safety reporting regulations for human drugs and biological products, among others.

Here’s a rundown of several of the many upcoming rulemakings that could impact pharmaceutical and medical device companies.

Harmonizing and Modernizing Regulation of Medical Device Quality Systems

With an action date set for April 2019, FDA said it intends to revise its Quality System regulations for medical devices to “supplant the existing requirements with the specifications of an international consensus standard for medical device manufacture, ISO 13485:2016.”

As Focus reported in February, FDA faces logistical challenges in making this switch, including revisions to multiple agency documents that reference 21 CFR Part 820 and training FDA investigators to audit against ISO 13485:2016. 

The unified agenda said the revisions are “intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements.”

Medical Device De Novo Classification Process

By July of this year, FDA said it will propose a rule to establish procedures and criteria for the de novo process that would make it more transparent and predictable for industry.

Certain Requirements Regarding Prescription Drug Marketing (203 Amendment) 

FDA says that by November, it will amend the regulations at 21 CFR 203 “to remove provisions no longer in effect and incorporate conforming changes following enactment of the Drug Supply Chain Security Act (DSCSA). In this proposed rulemaking, the Agency is amending the regulations to clarify provisions and avoid causing confusion with the new standards for wholesale distribution established by DSCSA.”

Reporting Information Regarding Falsification of Data 

By August, FDA said it’s looking to withdraw a proposed rule that was slated to require sponsors of certain clinical and nonclinical studies (and certain other entities) to promptly report to FDA information indicating that any person has or may have engaged in the falsification of data in the course of proposing, designing, performing, recording, supervising, or reviewing research, or in the course of reporting research results.

Post Approval Changes to Approved Applications

The proposed rule, set for March 2019, would update the existing regulations governing supplements and other changes to approved new drug applications (NDAs) abbreviated new drug applications (ANDAs), and biologics license applications (BLAs), as well as regulations regarding certain post-approval reports.

Biologics License Applications and Master Files

Beginning on 23 March 2020, the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deems any biological product approved in a new drug application (NDA) to be a biologics license application (BLA).

Some NDAs were approved using drug master files (DMFs), which allow an applicant to incorporate proprietary information from another manufacturer into its application by reference to the master file.

A proposed rule, expected this month, would permit the contained use of DMFs for NDAs subject to the BPCI Act transition.

FDA also proposes to release another biological product rule this month on defining biological products.

Responsibilities for the Initiation and Conduct of Clinical Investigations

Slated for April 2019, this proposed rule would update FDA’s investigational new drug application (IND) regulations to define and clarify the roles and responsibilities of the various persons engaged in the initiation, conduct and oversight of clinical investigations subject to IND requirements. 

“The proposed changes would better protect the rights, safety, and welfare of subjects and help ensure the integrity of clinical trial data.  The proposed rule should help reduce study misconduct and ensure the integrity of clinical trial data (benefits) while requiring additional documenting, reporting, and recordkeeping for clinical investigators (costs),” the rule says.

Institutional Review Boards; Cooperative Research 

This proposed rule, expected in December, would replace current FDA requirements for cooperative research such that any institution located in US and participating in multi-site cooperative research “would need to rely on approval by a single Institutional Review Board (IRB) for that portion of the research that is conducted in the U.S., with some exceptions. This proposed rule would also establish an IRB recordkeeping requirement for research that takes place at an institution in which IRB oversight is conducted by an IRB that is not operated by the institution.”

Pediatric Study Plan Requirements for New Drug and Biologics License Applications 

In April 2019, FDA plans to propose requirements for the content of initial pediatric study plans required to be submitted under the Pediatric Research Equity Act (PREA) which requires sponsors of certain applications to submit a plan for studying their drug/biologic in pediatric patients; a primary factor in the increased ability to provide labeling and other drug information for pediatric patients for many more drug and biological products.

“Developing drugs for pediatric populations presents unique challenges for drug manufacturers. Although the plans are required to be submitted based on the statutory provision, a regulation is required and will provide clarity, specificity, and direction to sponsors, as well as assist FDA in ensuring compliance, and ultimately help to better advance the study of drugs in pediatric populations to support advancing pediatric indications,” FDA said.

Final Rules

Postmarketing Safety Reporting Requirements for Human Drug and Biological Products 

The final rule would amend the postmarketing safety reporting regulations for human drugs and biological products, including blood and blood products, in order to better align FDA requirements with guidelines of the International Council on Harmonisation (ICH), and to update reporting requirements in light of current pharmacovigilance practice and safety information sources and enhance the quality of safety reports received by FDA.

“These revisions were proposed as part of a single rulemaking (68 FR 12406) to clarify and revise both premarketing and postmarketing safety reporting requirements for human drug and biological products. Premarketing safety reporting requirements were finalized in a separate final rule published on September 29, 2010 (75 FR 59961). This final rule applies to postmarketing safety reporting requirements,” FDA said.

Medical Device Classification Procedures 

Expected in November 2018, this final rule implements Section 608 of the Food and Drug Administration Safety and Innovation Act (FDASIA) requiring FDA to use administrative orders to announce or change the classification of devices, instead of taking action by regulation.

Fixed-Combination and Co-Packaged Drugs

This final rule, expected in February 2019, amends FDA regulations on fixed-combination prescription and over-the-counter (OTC) drugs.

“Current regulations require, among other things, that the sponsor of a fixed-combination drug demonstrate that each of the components makes a contribution to the drug's claimed effects. The final rule harmonizes the combination drug requirements into a single set of regulations for both prescription and OTC combination drugs, and codifies existing policy on what kinds of studies are needed to show that the combination drug requirements are met,” FDA said. “The final rule also applies these regulations to combinations of biological drug products and to drug-biological product combinations; clarifies application of FDA's requirements regarding fixed-dose combinations to certain natural source drugs and certain synthetic drugs; establishes circumstances under which the Agency might waive the combination requirements for a particular drug or biological product; and addresses the issue of co-packaging.”

Hematology and Pathology Devices; Classification of Blood Establishment Computer Software  

In June, FDA plans to finalize a rule to classify the blood establishment computer software (BECS) and BECS accessories into class II (special controls) and subject to premarket review.  FDA has identified special controls for BECS and BECS accessories that are necessary to provide a reasonable assurance of safety and effectiveness.

Unified Agenda – Spring 2018 Rule List


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