Massachusetts Issues Guidance on Device Manufacturer Conduct

The Massachusetts Department of Public Health (MDPH) issued guidance on the recently implemented pharmaceutical and medical device manufacturer conduct regulations. MDMA is pleased that MDPH clarified that the regulations do not apply to pre-commercial companies. Furthermore, companies without disclosure filings do not have to pay the required $2,000 fee. However, they do require any company interacting with a Massachusetts licensed health care practitioners with prescribing authority to comply with the new requirements.